From Teriparatide to Pembrolizumab: CDSCO Clears Import of r-DNA Drugs via CT-18 Route
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has granted multiple CT-18 approvals between January 2020 and December 2025 for recombinant DNA (r-DNA) origin drugs and biologics, enabling companies to import these products into India for sale and distribution.
CT-18 permissions are issued under the New Drugs and Clinical Trials Rules and are specifically related to import of unapproved new drugs or biologics into the country. These approvals mark an important step in expanding access to advanced protein-based therapies used in oncology, endocrinology, autoimmune disorders, osteoporosis, and metabolic diseases.
The approved products include monoclonal antibodies, recombinant hormones, peptide analogues, and other biologics developed through recombinant DNA technology. Such drugs include therapies for osteoporosis (e.g., Teriparatide), cancer biologics, immunology products, and metabolic disorder treatments, all of which are produced using genetically engineered cell systems rather than chemical synthesis. These medicines play a crucial role in treating chronic, life-threatening, and rare conditions, offering targeted mechanisms of action, improved safety profiles, and better therapeutic outcomes. Their approval for import ensures Indian patients gain access to globally developed advanced biologics.
The list of r-DNA origin drugs approved to be imported in 2025 includes AstraZeneca Pharma India Ltd’s Eculizumab and multiple approvals for Durvalumab across new indications, alongside MSD Pharmaceuticals Pvt. Ltd’s Sotatercept and Pembrolizumab, Roche Products (India) Pvt. Ltd’s Polatuzumab Vedotin, Atezolizumab, and Crovalimab, Novo Nordisk India Pvt. Ltd’s Insulin Icodec, Semaglutide Injection, and Concizumab, Intas Pharmaceuticals Ltd’s Serplulimab, Sun Pharmaceutical Industries Ltd’s Tildrakizumab (r-DNA origin), Bristol-Myers Squibb India Pvt. Ltd’s Luspatercept, Novartis Healthcare Pvt. Ltd’s Secukinumab, Bayer Pharmaceuticals Pvt. Ltd’s Antihemophilic Factor (Recombinant Factor VIII), Pfizer Products India Pvt. Ltd’s Marstacimab, and Eisai Pharmaceuticals India Pvt. Ltd’s Lecanamab, reflecting a strong pipeline of recombinant biologics spanning oncology, hematology, immunology, endocrinology, and rare diseases approved for import and marketing during the year.
List of new drugs (r-DNA origin) approved for import and marketing in India during Jan, 2020 – Dec, 2025 | ||||||
S. No. | Name of the firm | Date of Permission | Permission No. /CDSCO Reference No. | Name of the Drug | Indication | Dosage Form & Strength |
1 | M/s Bristol- Myers Squibb India Pvt. Ltd. | 21-02-2020 | IMP/BIO/20/000008 | Ipilimumab Injection, 50 mg/10 mL (5 mg/mL), Single use vial | Renal Cell Carcinoma (RCC) Ipilimumab is indicated for treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma, in combination with Nivolumab. Recommended dosage Combination phase: The recommended dose during the combination phase is Ipilimumab 1 mg/kg administered intravenously over a period of 30 minutes every 3 weeks for the first 4 doses in combination with Nivolumab 3 mg/kg administered intravenously over a period of 30 minutes, followed by the single-agent phase. Single- agent phase: The recommended dose of Nivolumab during the single- agent phase is 3 mg/kg every two weeks administered intravenously over a period of 30 minutes. | Dosage Form: concentrate for solution for infusion for intravenous injection Strength: 5 mg/mL |
2. | M/s Sandoz Private Limited | 15.03.2020 | IMP/BIO/19/000001 (Initial approval granted on 18.02.2019) | Ranibizumab Solution for injection in vial 10mg/mL + filter needle | Ranibizumab is indicated in preterm inf ants for: The treatment of retinopathy of prematurity (ROP) with zone I (stage1+, 2+, 3 or 3+), zone II (stage 3+) or AP-ROP (aggressive posterior ROP) disease (Additional Indication) | Solution for injection. Each Vial contains 2.3 mg of Ranibizumab in 0.23 mL solution. Strength: 10 mg/mL, |
3 | M/s Sandoz Private Limited | 26-03-2020 | IMP/BIO/20/000026 | Crizanlizumab Concentrate for solution for infusion 10 mg/mL (100mg/10mL) | Crizanlizumab is indicated to reduce the frequency of vasoocclusive crises in adults and pediatric patients aged 16 years and older with sickle cell disease. | Dosage Form: Concentrate for solution for infusion Strength: 10mg/mL |
4 | M/s Dr. Reddy’s Laboratories Ltd | 3-04-2020 | IMP/BIO/20/000029 | Evolocumab Solution for Injection 140mg/ml (r-DNA origin) |
statin with or without other lipid- lowering therapies or, | Dosage Form: Solution for Injection. Each single use Prefilled Syringe / Prefilled Autoinjector Strength: Evolocumab Injection 140 mg/mL |
5 | M/s Sandoz Private Limited | 1-07-2020 | IMP/BIO/20/000056 | Brolucizumab solution for injection 120 mg/mL (r-DNA origin) | For the treatment of neovascular (wet) age-related macular degeneration (AMD) | Dosage Form: Solution for Injection (1 Vial + 1 filter needle) Strength: 120 mg/mL |
6 | M/s Novo Nordisk India Pvt Ltd | 16-07-2020 | IMP/BIO/20/000059 | Catridecacog (recombinant coagulation factor XIII) 2500 IU (Novo Thirteen) | Long term prophylactic treatment of bleeding in patients with congenital factor XIII A subunit deficiency. Novo Thirteen can be used for all age groups | Dosage Form: Lyophilized Powder for solution for injectionin vial Strength: 2500 IU |
7 | M/s Novo Nordisk India Pvt Ltd | 27-07-2020 | IMP/BIO/20/000060 | Semaglutide | Semaglutide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications; • in combination with | Dosage Form: Solid oral (tablets). Semaglutide Strength 3 mg Tablets, 7 mg Tablets and 14 mg |
other medicinal products for the treatment of diabetes | Tablets | |||||
8 | M/s Novo Nordisk India Pvt Ltd | 5-08-2020 | IMP/BIO/20/000063 | Nonacog beta pegol | Nonacog beta pegol is indicated for treatment and prophylaxis of bleeding in pretreated patients with haemophilia B (congenital factor IX deficiency | Dosage Form: Lyophilized Powder for solution for injection. Nonacog beta pegol Strength: 500.0 IU/Vial , 1000.0 IU/Vial and 2000.0 IU/Vial |
9 | M/s Baxalta Bioscience India Pvt.Ltd | 9-09-2020 | IMP/BIO/20/000068 | Rurioctocog alfa pegol (PEGylated recombinant human FVIII) | Rurioctocog alfa pegol (Adynovate) is a human antihemophilic factor indicated in children and adults with Hemophilia A (congenital factor VIII deficiency) for: □ On-demand treatment and control of bleeding episodes □ Perioperative management □ Routine prophylaxis to reduce the frequency of bleeding episodes | Dosage Form: Lyophilized Powder for solution for injection, Strength: 250 IU/500 IU/750 IU/1000 IU/1500 IU/2000 IU vials |
10 | M/s Cipla Limited | 27-10-2020 | IMP/BIO/20/000082 Note: Additional Marketing Authorization | Recombinant Human Growth Hormone (Somatropin) Injection 4 IU, (IP) | Long term, treatment of children who have growth failure due to endogenous growth hormone and for treatment of short stature in children with Turner's syndrome confirmed by Chromosomal analysis | Dosage Form: Powder for solution for Injection. Each vial of Recombinant human Growth Hormone (EUTROPIN) contains 4 IU of Recombinant Human Growth Hormone (somatropin). The pack is supplied with 1 mL vial for injection for subcutaneous use |
11 | M/s Merck Specialities Private Limited | 29-10-2020 | IMP/BIO/20/000085 | Follitropin alfa (r- DNA origin) and Lutropin alfa (r- DNA origin) Injection (Brand Name: Pergoveris) | Pergoveris is indicated for the stimulation of follicular development in adult women with severe LH and FSH deficiency | Dosage Form: Solution for Injection in Prefilled Pen Strength: 1. Pergoveris (300 IU rhFSH + 150 IU r- hLH)/0.48 mL;
+ 225 IU r-hLH)/0.72 mL;
|
rhFSH + 450 IU r- hLH)/1.44 mL. | ||||||
12 | M/s AstraZeneca Pharma India Limited | 16-12-2020 | IMP/BIO/20/000097 | Benralizumab | Benralizumab is indicated as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype in adult patients. The recommended dose is 30 mg of Benralizumab by subcutaneous injection every 4 weeks for the first 3 doses, and then every 8 weeks thereafter | Dosage Form: Solution for injection in a single dose prefilled syringe (with Needle Safety Guard) for Subcutaneous administration only Strength: 30 mg/mL |
13 | M/s Novo Nordisk India Private Limited | 02-03-2021 | IMP/BIO/21/000001 | Turoctocog Alfa Pegol | Turoctocog alfa pegol [antihemophilic factor (recombinant), glycopegylated-exei] is a recombinant DNA-derived coagulation Factor VIII concentrate indicated for use in adults and children with hemophilia A for: □ On-demand treatment and control of bleeding episodes □ Perioperative management of bleeding □ Routine prophylaxis to reduce the frequency of bleeding episodes Limitation of Use: Turoctocog alfa pegol is not indicated for the treatment of von Willebrand disease | Dosage Form: Turoctocog alfa pegol lyophilised powder for reconstitution into a solution for injection for intravenous use Strengths: 500 IU/vial, 1000 IU/vial, 1500 IU/vial, 2000 IU/vial and 3000 IU/vial; single dose vial pack for single use administration |
14 | M/s Novartis Healthcare Private Limited | 12-03-2021 | IMP/BIO/21/000004 PAC- IMP/BIO/25/000140 for approval of additional pack presentation | Ofatumumab | Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. | Dosage Form: Solution for injection in pre-filled syringe/ pre-filled pen Strength: Ofatumumab 20 mg/0.4 mL |
15 | M/s Novartis Healthcare | 26-03-2021 | Import 6200/05 dated 26.10.2005, 12-57/05- DC/Novartis/09. Suppl.Changes-1 dated 01.04.2010, 4- 16/Novartis/PAC-R- Omalizumab/14-BD | Omalizumab | Additional indication - Omalizuamb is indicated as an add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and | (a) Omalizumab powder and solvent for solution for injection 75 mg & 150 mg single-use vial (b) Omalizumab solution for injection in a pre- filled syringe 75 mg/0.5 mL and 150 mg/1.0 mL |
Private Limited | dated 22.10.2014, 4- 17/Novartis/PAC-R- Omalizumab/15-BD dated 18.05.2015, 4- 160/ Novartis/PAC- R-Omalizumab/15- BD dated 26.10.2015 | above) with severe Chronic rhinosinusitis with nasal polyps for whom therapy with INC does not provide adequate disease control | single-use pre-filled syringe; for subcutaneous administration only | |||
16 | M/s Sanofi- synthelabo (India) Pvt. Ltd. | 08-04-2021 | P-119/2016 dated 02-Aug-2016 | Agalsidase Beta | Agalsidase Beta is indicated for long term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry Disease (α- galactosidase A deficiency) | additional strength Agalsidase Beta (r-DNA origin) 5 mg Vial, Dosage Form: Powder for Concentrate for Solution for Infusion |
17 | M/s Roche Products (India) Pvt. Ltd | 03-05-2021 | IMP/BIO/21/000017 | Casirivimab (r- DNA origin) and Imdevimab (r- DNA origin) | Combination of Casirivimab and Imdevimab indicated for restricted use in emergency situation, for the treatment of mild to moderate corona virus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with laboratory confirmed SARS- COV2 infection and who are at high risk of severe COVID-19 and does not require oxygen. | Casirivimab is a sterile, preservative-free, clear to slightly opalescent, color less to pale yellow solution. Imdevimab is a sterile, preservative- free, clear to slightly opalescent, color less to pale yellow solution with a pH of 6.0. Casirivimab and Imdevimab are each supplied in individual single-dose vials. Casirivimab and Imdevimab is approved at combine dose of 1200 mg (600 mg of each drug) administered by intravenous infusion or subcutaneous route. |
18 | M/s Amgen Technology Private Limited, | 04-05-2021 | IMP/BIO/21/000018 | Romosozumab | Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture Romosozumab is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. | Romosozumab (r-DNA origin) Injection 90 mg/mL. 105 mg/1.17mL clear to opalescent, colorless to light yellow solution for injection in a single- use prefilled syringe for Subcutaneous use Strength: 90mg/mL |
19 | M/s Johnson & Johnson Pvt. Ltd | 01-06-2021 | IMP/BIO/21/000027 | Daratumumab | a) In combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. b) In combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant. c) For the treatment of patients with multiple myeloma who have received at least one prior therapy. d) For the treatment of patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent. | Daratumumab 1800 mg (120 mg/mL). The product is supplied in vial as a sterile, 120mg/mL liquid for subcutaneous injection. Each vial contains 1800 mg of Daratumumab in a 15mL nominal fill volume and an excess volume of at least 1.3mL. The Drug Product contains no preservatives and is for single use only. |
20 | M/s Merck Specialities Private Limited | 02-06-2021 | IMP/BIO/19/000052 (Drug originally approved on 31- Dec- 2019 | Avelumab | Additional indication - 1) Avelumab is indicated as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has not progressed with first-line platinum-based induction chemotherapy. 2) Avelumab in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) | Avelumab concentrate for solution for infusion (Intravenous Infusion) Strength: 20 mg/ml vial |
21 | M/s Roche Products (India) Pvt. Ltd | 09-06-2021 | IMP/BIO/21/000030 | Satralizumab | Satralizumab is indicated as monotherapy or in combination with immunosuppressants for the treatment of adult and adolescent patients with neuromyelitis optica spectrum disorders (NMOSD). | Satralizumab Injection 120 mg/ml pre-filled syringe (PFS) with needle safety device (NSD) for subcutaneous use for single dose administration |
22 | M/s Eli Lilly and Company (India) Pvt. Ltd. | 06-07-2021 | IMP/BIO/21/000038 | Insulin Lispro Ultrarapid | Treatment of diabetes mellitus in adults. | Solution for Injection 100 units/ml and 200 units/ml Presentations:
Injection 100 units/ml, 3ml cartridge & 3ml prefilled pen
Injection 100 units/mL, 10ml vial, multiple dose for Subcutaneous and Intravenous use
200 units/ml, 3ml prefilled pen |
23 | M/s Pfizer Limited | 29-09-2021 | MP/BIO/21/000080 | Infliximab | Crohn’s Disease
Infliximab is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn’s disease. Pediatric Crohn’s Disease
| Lyophilized Powder for Concentrate for Solution for Intravenous Infusion; Strength: 100 mg powder per vial |
symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy. Ulcerative Colitis
Pediatric Ulcerative Colitis
Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis
|
inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis. | ||||||
24 | M/s Roche Products (India) Pvt. Ltd. | 01-10-2021 | IMP/BIO/21/00 0082 | Pertuzumab- Trastuzumab |
HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease | Solution for subcutaneous injection Strength: 600mg Pertuzumab + 600mg Trastuzumab [10ml/15cc vial] and 1200mg Pertuzumab + 600mg Trastuzumab vial [15ml/20cc vial] |
25 | M/s Bristol- Myers Squibb India Pvt. Ltd. | 09-06-2016 | IMP-88/2016 | Nivolumab |
on 09.06.2016).
chemotherapy, is indicated for the first- line | Nivolumab concentrate for solution for infusion; 40 mg and 100 mg Strength: 10 mg/mL |
treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations (additional indication approved on 09.04.2021)
Nivolumab as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck after platinum based therapy (additional indication approved on 04.10.2017).
metastatic melanoma (approved on 02.07.2018)
(additional indication approved on 12.06.2018): |
Nivolumab is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after:
Nivolumab is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:
a fluoropyrimidine, oxaliplatin, and irinotecan (additional indication approved on 18.04.2019).
adenocarcinoma (additional indication approved on |
30.11.2021). 10) Adjuvant treatment of Resected Junction Cancer (EC or GEJC) Esophageal or Gastroesophageal: Nivolumab is indicated for the adjuvant treatment of esophageal or completely resected gastroesophageal junction cancer with residual pathologic disease in patients, who have received neoadjuvant chemoradiotherapy (CRT) (additional indication approved on 30.11.2021). | ||||||
26 | M/s Cipla Limited | 14-10-2021 | IMP/BIO/21/000085 Note: Additional Marketing Authorization | Insulin Lispro I.P. | Diabetes mellitus | Suspension for Injection Strength: 100 IU/mL, Cartridge and prefilled pen and 200U/ml, prefilled pen |
27 | M/s Cipla Limited | 30-09-2021 | IMP/BIO/21/000084 Note: Additional Marketing Authorization | Insulin Lispro Biphasic I njection I.P. (25% Insulin Lispro and 75% Insulin Lispro Protamine) | Diabetes mellitus | Suspension for Injection in Cartridge and prefilled pen Strength: 100IU/mL |
28 | M/s Takeda Pharmaceutical s India Pvt. Ltd. | 20-10-2021 | IMP/BIO/21/000089 | Brentuximab Vedotin | Previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy
cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) | Powder for concentrate for solution for infusion in vial Strength: 50 mg |
29 | M/s Cipla Limited | 29-11-2021 | IMP/BIO/21/000096 Note: Additional Marketing Authorization | Recombinant Human Erythropoietin injection I.P. | For treatment of anemia in chronic renal failure patients | Solution for injection Strength: 2000 IU/0.5 ml, 3000 IU/0.3 ml, 4000 IU/0.4 ml, 6000 IU/0.6 ml, 8000 IU/0.8 ml |
and 10000 IU/1.0ml Solution for injection in pre-filled syringe | ||||||
30 | M/s Cipla Limited | 09-12-2021 | IMP/BIO/21/000100 Note: Additional Marketing Authorization | Insulin Lispro Biphasic Injection I.P. (50% Insulin Lispro and 50% Insulin Lispro Protamine suspension) Injection (r-DNA origin) | For the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis | Suspension for injection in Cartridge & prefilled pen Strength:100 IU/mL |
31 | M/s Cipla Limited | 22-12-2021 | IMP/BIO/21/000106 Note: Additional Marketing Authorization | Recombinant Human Erythropoietin injection I.P. | For treatment of anemia in chronic renal failure patients | Solution for injection in vial Strength:10,000 IU/ 1mL, 20,000 IU/2mL |
32 | M/s Dr. Reddy’s Laboratories Limited | 05-01-2022 | IMP/BIO/22/000001 | Romosozumab | Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture Romosozumab is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. Limitations of Use The anabolic effect of Romosozumab wanes after 12 monthly doses of therapy. Therefore, the duration of Romosozumab use should be limited to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered. Two 105 mg/1.17 mL single use prefilled syringes are required to administer the recommended 210 mg dose of Romosozumab | Solution for injection in a single-use prefilled syringe for Subcutaneous use. Strength: 90 mg/mL |
33 | M/s Bristol- Myers Squibb India Pvt. Ltd. | 12-01-2022 | IMP/BIO/22/000002 | Luspatercept | Myelodysplastic syndromes (MDS): Luspatercept is indicated for the treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate- risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had | Lyophilized Powder for solution for injection in vial. Strength: 25 mg and 75 |
an unsatisfactory response to or are ineligible for erythropoietin- based therapy. β-thalassemia: Luspatercept is indicated for the treatment of adult patients with transfusion-dependent anaemia associated with beta- thalassaemia. | mg | |||||
34 | M/s Cipla Limited | 04-02-2022 | IMP/BIO/22/000006 Note: Additional Marketing Authorization | Dulaglutide | Dulaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated:
factors. | Dosage Form: Solution for Injection Strength: 0.75 mg/0.5 ml in Prefilled Pen and 1.5 mg/0.5 ml |
35 | M/s Johnson & Johnson Pvt. Ltd., | 02-01-2017 | IMP-223/2016 | Daratumumab |
dexamethasone, or bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (indication approved on 08.02.2022).
patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory | Concentrate for solution for infusion Strength: 20 mg/mL |
agent and who have demonstrated disease progression on the last therapy (indication approved on 08.02.2022). | ||||||
36 | M/s Eli Lilly and Company (India) Pvt. Ltd. | 07-02-2022 | IMP/BIO/22/00 0012 | Ixekizumab |
phototherapy | Solution for Injection in Prefilled Autoinjector and Prefilled Syringe Strength: 80 mg/mL |
37 | M/s Johnson & Johnson Pvt. Ltd. | 08-02-2022 | IMP/BIO/22/000013 | Amivantamab | Treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal-growth factor receptor (EGFR) Exon 20 insertion mutations whose disease has progressed on or after platinum- based chemo- therapy. | Liquid concentrate for infusion Strength: 50 mg/mL |
38 | M/s Cipla Limited | 07-02-2022 | IMP/BIO/22/000011 Note: Additional Marketing Authorization | Recombinant Human Follicle stimulating Hormone solution for injection I.P. | Treatment of female infertility | Solution for injection Strengths: 75IU/ 0.15mL, 150 IU/0.3mL, 225 IU/0.45mL, 300 IU/0.6mL Solution for injection in prefilled syringe |
39 | M/s GlaxoSmithKlin e Pharmaceutical s Limited | 12-06-2018 | IMP147/2018 | Mepolizumab | Eosinophilic granulomatosis with polyangiitis (EGPA) Mepolizumab is indicated as an add-on treatment for adult patients with relapsingremitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA). Hypereosinophilic syndrome (HES) Mepolizumab is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable nonhaematologic secondary cause (additional indication approved on 15.03.2022) | Solution for injection in pre-filled pen (auto- injector) or pre-filled syringe (safety syringe) Strength:100 mg/mL |
40 | M/s Johnson & Johnson Pvt. Ltd. | 10-03-2022 | IMP/BIO/22/000020 | Ustekinumab | Ustekinumab is indicated for:
· Inducing and maintaining clinical remission,
in adults with moderately to severely active Crohn’s disease who:
| Strength: 130 mg/ 26 ml,
Strength: 45 mg/0.5 ml, Strength: 90 mg/ml |
41 | M/s Novo Nordisk India Pvt. Ltd. | 20-04-2022 | IMP/BIO/22/000031 | Semaglutide | It is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of · 30 kg/m2 or greater (obesity) or
Limitations of Use:
prescription drugs, over-the- counter drugs, and herbal preparations, have not been established.
| Solution for injection (in prefilled pen (Single dose Pen injector) Strength: Each pre- filled pen contains
in 0.5 mL,
0.5 mL, 3. 1.0 mg semaglutide in 0.5 mL, 4. 1.7 mg semaglutide in 0.75 mL and, 5. 2.4 mg semaglutide in 0.75 mL |
42 | M/s Takeda Pharmaceutical s India Pvt. Ltd. | 26-07-2022 | IMP/BIO/22/000053 | Vedolizumab | Vedolizumab 108mg is indicated as only for maintenance treatment by subcutaneous route once every 2 weeks, following at least 2 intravenous infusions (Vedolizumab IV 300 mg), for the following indications: Ulcerative colitis Vedolizumab is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with lost response to or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist. Crohn’s disease Vedolizumab is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with lost response to or were intolerant to either conventional therapy or a tumor necrosis factor- alpha (TNFα) antagonist | Solution for injection in Pre-filled syringe with Needle safety device & Pre-filled syringe with Autoinjector Strength: 108 mg |
43 | M/s Pfizer Products India Private Limited | 12-08-2022 | IMP/BIO/22/000055 | Somatrogon | Indicated for the treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone | Solution for injection Strength: Each Prefilled pen contains:
prefilled pen. |
44 | M/s Novo Nordisk India Pvt. Ltd. | 17-10-2022 | IMP/BIO/22/000068 | Semaglutide | It is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of
Limitations of Use:
| Solution for Injection in Prefilled Pen Strength: 0.25mg/0.5mg/1mg/1.7mg/ 2.4mg |
products or with any other GLP-1 receptor agonist.
pancreatitis. | ||||||
45 | M/s Bristol- Myers Squibb India Pvt. Ltd. | 02-11-2022 | IMP-88/2016 | Nivolumab |
| Concentrate for solution for infusion in vial Strength: 240 mg in vial (10 mg/ml) |
treatment of adult and pediatric (12 years and older) pati ents with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
| ||||||
46 | M/s MSD Pharmaceutical s Private Limited | 25-11-2022 | IMP-093/2016 | Pembrolizumab |
PD-L1 with a CPS 10 | Solution for infusion Strength: 100 mg/4mL (25 mg/ml) |
47 | M/s Sandoz Private Limited | 13-12-2022 | IMP/BIO/20/000056 | Brolucizumab | Indicated for the treatment of DME (Diabetic Macular Edema) | Solution for injection in vial + filter needle Strength: 120 mg/ml |
48 | M/s Takeda Biopharmaceut icals India Pvt. Ltd. | 31-01-2023 | IMP/BIO/23/000001 Note: Due to name change MA is re- issued. | Vedolizumab | Vedolizumab is indicated for the treatment of:
| Dosage Form: Powder for concentrate for solution for infusion. Strength: 300 mg |
severely active Crohn’s Disease who have had an inadequate response with, lost response to or were intolerant to either conventional therapy or tumor necrosis factor-alpha (TNF-α) antagonist. | ||||||
49 | M/s Takeda Biopharmaceut icals India Pvt. Ltd. | 31-01-2023 | IMP/BIO/23/000002 Note: Due to name change MA is re- issued. | Recombinant Antihemophilic Factor VIII (r-AHF- VIII) | For supplementing blood coagulation factor VIII and suppresses bleeding tendency in congenital blood coagulation factor VIII deficient patients (Haemophilia A). | Dosage Form: Lyophilized Powder for Concentrated for Solution for Intravenous Injection Strength: 250IU, 500IU, 1000IU |
50 | M/s Takeda Biopharmaceut icals India Pvt. Ltd. | 31-01-2023 | IMP/BIO/23/000003 Note: Due to name change MA is re- issued. | Coagulation Factor IX (Recombinant) | Coagulation Factor IX (Recombinant) is an antihemophilic factor indicated for:
| Dosage Form: Lyophilized Powder for Solution (for Intravenous use only) Strength: 250 IU/500 IU/1000 IU/2000 IU and 3000 IU |
51 | M/s Eli Lilly and Company (India) Pvt. Ltd. | 06-02-2023 | IMP/BIO/23/000005 | Galcanezumab | Galcanezumab is indicated for the preventive treatment of migraine in adults. | Dosage Form: Solution for injection as single-dose Prefilled Pen and Prefilled Syringe. Strength: 120 mg/ml |
52 | M/s AstraZeneca Pharma India Limited. | 06-02-2023 | IMP/BIO/23/000004 | Durvalumab | Durvalumab (IMFINZI) in combination with chemotherapy is indicated for the treatment of patients with locally advanced or metastatic biliary tract cancer (BTC) | Dosage Form: Solution for infusion Strength: 120 mg/2.4 mL and 500 mg/10 mL |
53 | M/s Takeda Biopharmaceut icals India Pvt. Ltd. | 07-02-2023 | IMP/BIO/23/000006 Note: Due to name change MA is re- issued. | Idursulfase | Idursulfase is indicated for the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II) | Dosage Form: Concentrate for Solution for (IV) Infusion. Strength: 2mg/ ml |
54 | M/s Takeda Biopharmaceut icals India Pvt. Ltd. | 08-02-2023 | IMP/BIO/23/000007 Note: Due to name change MA is re- issued. | Velaglucerase Alfa | Velaglucerase Alfa is indicated for long-term enzyme replacement therapy (ERT) in patients with type 1 Gaucher disease. | Dosage Form: Powder for Solution for Infusion in single use vial. Strength: 400 units |
55 | M/s Takeda Biopharmaceut icals India Pvt. Ltd. | 13-02-2023 | IMP/BIO/23/000009 Note: Due to name change MA is re- issued. | Agalsidase alfa | Agalsidase alfa is indicated for long-term enzyme replacement therapy inpatients with a confirmed diagnosis of Fabry Disease (α-galactosidase A deficiency). | Dosage Form: Concentrate solution for intravenous infusion Strength: 1mg/ml |
56 | M/s Takeda Biopharmaceut icals India Pvt. Ltd | 13-02-2023 | IMP/BIO/23/000010 Note: Due to name change MA is re- issued. | Vedolizumab | Vedolizumab 108mg is indicated as only for maintenance treatment by subcutaneous route once every 2 weeks, following at least 2 intravenous infusions (Vedolizumab IV 300 mg), for the following indications: Ulcerative colitis Vedolizumab is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with lost response to or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist. Crohn’s disease Vedolizumab is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with lost response to or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist | Dosage Form: Solution for injection in Pre-filled syringe with Needle safety device & Pre-filled syringe with Autoinjector Strength: 108mg |
57 | M/s Takeda Biopharmaceut icals India Pvt. Ltd | 13-02-2023 | IMP/BIO/23/000011 Note: Due to name change MA is re- issued. | Rurioctocog alfa pegol | Rurioctocog alfa pegol (Adynovate) is a human antihemophilic factor indicated in children and adults with Hemophilia A (congenital factor VIII deficiency) for:
| Dosage Form: Lyophilized Powder for solution for injection Strength: 250IU/vial, 500IU/vial, 750IU/vial, 1000IU/vial, 1500IU/vial in 2ml, 2000IU/vial in 5ml |
58 | M/s Sanofi Healthcare India Private Limited | 21-02-2023 | IMP/BIO/23/000016 | Insulin Glargine + Lixisenatide | For treatment of adults patients with Obesity with insufficiently controlled type 2 diabetes mellitus to improve glycemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT2 inhibitors, when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product (sulfonylurea, glinide, DPP-4 inhibitors or gliptins, and Sodium- glucose co-transporter 2 (SGLT2) inhibitors or gliflozins) or with basal insulin or with glucagon-like peptide-1 (GLP-1) receptor agonist | Dosage Form: Solution for Subcutaneous injection in prefilled pen Strength: 100 U/ml + 33 mcg/ml and 100 U/ml + 50 mcg/ml |
59 | M/s Takeda Biopharmaceut icals India Pvt. Ltd | 22-03-2023 | IMP/BIO/23/000025 Note: Due to name change MA is re- issued. | Coagulation Factor VIII (Recombinant) rFVIII | Treatment and prophylaxis of bleeding in patients with Haemophilia A (Congenital factor VIII deficiency) in all age groups. | Dosage Form: Powder and Solvent for Solution for Injection along with Baxjact II reconstitution device Strength: 250 IU/ 500IU/ 1000 IU/1500 IU/2000 IU/3000 IU |
60 | M/s Takeda Biopharmaceut icals India Pvt. Ltd | 24-03-2023 | IMP/BIO/23/000029 Note: Due to name change MA is re- issued. | Brentuximab Vedotin |
lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF). | Dosage Form: Powder for concentrate for solution for infusion in vial Strength: 50 mg |
61 | M/s Roche Products (india) Private Limited | 24-03-2023 | IMP/BIO/23/000032 PAC- IMP/BIO/25/000145 for approval of additional pack presentation | Faricimab | Indicated for the treatment of:
| Dosage Form: Intravitreal solution for injection/ Pre- filled syringe (PFS) with Injection filter needle (with a shelf life of 18M at 2-8 °C) Strength: 6 mg/0.05 mL |
(120mg/mL) | ||||||
62 | M/s Roche Products (India) Private Limited | 24-03-2023 | IMP/BIO/23/000028 | Ocrelizumab | Ocrelizumab is indicated for the treatment of:
| Dosage Form: single-dose vial. Strength: 30 mg/ml |
63 | M/s Boehringer Ingelheim India Private Limited | 24-03-2023 | IMP/BIO/23/000031 | Spesolimab | Spesolimab is indicated for the treatment of flares in adult patients with Generalized Pustular Psoriasis | Dosage Form: Concentrate for solution for infusion 450 mg/7.5 ml (60 mg/ml) in 10 ml vial administered through intravenous (IV) route Strength: 60 mg/ml |
64 | M/s GSK Pharma India Private Limited | 26-04-2023 | IMP/BIO/23/000048 | Dostarlimab | Dostarlimab is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability high (MSI-H) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen. | Dosage Form: Concentrate for solution for infusion (sterile concentrate) Strength: 500 mg/ 10 mL |
65 | M/s Cipla Limited | 26-04-2023 | IMP/BIO/23/000049 Note: Additional Marketing Authorization | Insulin Lispro Ultrarapid (UR) Injection | Treatment of diabetes mellitus in adults. | Dosage Form: Solution for Injection Strength: 100 Units/mL in 3 ml cartridge and prefilled pen |
66 | M/s AstraZeneca Pharma India Limited | 01-05-2023 | IMP/BIO/23/000054 | Trastuzumab deruxtecan | Trastuzumab deruxtecan is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen | Dosage Form: Single use sterile, lyophilized powder for concentrate for solution for infusion Strength: 100 mg/ 5 ml |
67 | M/s Sanofi India Limited | 16-05-2023 | IMP/BIO/23/000058 | Biphasic Insulin Aspart Injection IP | Biphasic Insulin Aspart Injection I.P. is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 10 years and above. | Dosage Form: 30% Soluble insulin aspart IP and 70 % protamine- crystallised insulin aspart IP; suspension for |
injection. Strength: 100 IU/mL in 3 mL cartridge and 3 mL cartridge in pen injector. | ||||||
68 | M/s AstraZeneca Pharma India Limited | 26-05-2023 | IMP/BIO/23/000061 | Tremelimumab | Tremelimumab in combination with durvalumab is indicated for the treatment of patients with unresectable hepatocellular carcinoma (uHCC) | Dosage Form: 25mg/ 1.25mL and 300 mg/ 15mL Solution for infusion in single dose vial Strength: 20 mg/mL |
69 | M/s MSD Pharmaceutical Private Limited | 31-05-2023 | IMP/BIO/23/000063 | Pembrolizumab Injection |
breast cancer at high risk of recurrence. | Dosage Form: Solution in single vial Strength: 25 mg/mL |
70 | M/s Sanofi Healthcare India Private Limited | 14-06-2023 | IMP/BIO/23/000066 | Avalglucosidase Alfa | Avalglucosidase Alfa is indicated for the treatment of long-term enzyme replacement therapy for the treatment of patients with Pompe disease (acid - glucosidase deficiency) | Dosage Form: Powder for concentrate for solution for infusion Strength: 100 mg/Vial |
71 | M/s Cipla Limited | 01-08-2023 | IMP/BIO/23/000076 Note: Additional Marketing Authorization | Insulin Glargine IP | Insulin Glargine is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above. | Dosage Form: Solution for injection Strength: 100 Units/mL in 3 ml cartridge and 3 ml pre-filled pen |
72 | M/s Bristol- Mayer Squibb India Pvt. Ltd. | 01-09-2023 | IMP/BIO/23/000083 | Nivolumab | Additional Indication: Renal Cell Carcinoma (RCC) Nivolumab in combination with cabozantinib, is indicated for the first line treatment of patients with advanced Renal Cell Carcinoma (RCC). | Dosage Form: concentrate for solution for infusion. Strength: 10 mg/ml |
73 | M/s Roche Products (India) Private Limited | 04-09-2023 | IMP/BIO/23/000087 | Polatuzumab Vedotin | Polatuzumab vedotin in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R- CHP) is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL) | Dosage Form: Powder for concentrate for solution for infusion Strength: 30 mg/Vial and 140 mg/Vial |
74 | M/s Johnson & Johnson Pvt. Ltd. | 11-09-2023 | IMP/BIO/23/000090 | Teclistamab | Teclistamab is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. | Dosage Form: Powder for concentrate for solution for infusion. Strength: 10 mg/mL |
75 | M/s AstraZeneca Pharma India Limited | 25-09-2023 | IMP/BIO/23/000092 | Palivizumab | Palivizumab is indicated for the prevention of serious lower respiratory tract disease requiring hospitalization caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease:
disease (CHD). | Dosage Form: single dose vials administered through intramuscular route. Strength: 100 mg/mL |
76 | M/s Novo Nordisk India Pvt. Ltd. | 22-11-2023 | IMP/BIO/23/000104 | Somapacitan | Somapacitan is indicated for the replacement of endogenous growth hormone (GH) in children and adolescents with growth failure due to growth hormone deficiency (paediatric GHD (GHD)) and in adults with growth hormone deficiency (adult GHD (AGHD)) | Dosage Form: Solution for Injection in pre-filled pen Strength: 10 mg/1.5ml; 15 mg/1.5ml |
77 | M/s Pfizer Products (India) Private Limited | 28-11-2023 | IMP/BIO/23/000105 Note: This product was initially approved on 05.09.2018. Based on the application, the modification of approved indication is approved. | Nonacog Alfa (Recombinant human coagulation factor IX) | Revised Therapeutic Indication: Nonacog alfa (recombinant coagulation factor IX) is a recombinant human blood coagulation factor IX indicated for adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for:
Limitations of Use: Nonacog alfa (recombinant coagulation factor IX) is not indicated for induction of immune tolerance in patients with hemophilia B | Dosage Form: powder and solvent for solution for injection Strength: 250IU, 500IU, 1000IU, 2000IU and 3000 IU |
78 | M/s Sanofi Healthcare India Private Limited | 22-12-2023 | IMP/BIO/23/000110 | Olipudase alfa | Olipudase alfa is indicated as enzyme replacement therapy for long-term treatment of non-central nervous system (CNS) manifestations of acid sphingomyelinase deficiency (ASMD) in pediatric and adult patients. | Dosage Form: Powder for concentrate for solution for infusion. Strength: 21.2 mg/ Vial |
79 | M/s Astellas Pharma India Pvt. Ltd. | 08-01-2024 | IMP/BIO/24/000001 | Enfortumab vedotin | Enfortumab vedotin as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor 1 or programmed death ligand 1 inhibitor | Dosage Form: Powder for concentrate for solution for infusion. Strength: 20 mg/vial & 30mg/vial After reconstitution, each mL of solution contains 10mg of Enfortumab vedotin |
80 | M/s Bristol- Myers Squibb India Pvt. Ltd. | 17-01-2024 | IMP/BIO/24/000006 Note: Approval of Additional Indication. | Nivolumab | Additional Indication:
patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing | Dosage Form: concentrate for solution for infusion. Strength: 10 mg/mL |
radical resection of UC] | ||||||
81 | M/s Novo Nordisk India Private Limited | 17-01-2024 | IMP/BIO/24/000005 Note: This product was initially approved on 27.07.2020. Based on the application, the modification of approved indication is approved | Semaglutide tablets | Revised Therapeutic Indication: RYBELSUS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use
| Dosage Form: Tablets. Strength: 3mg. 7mg & 14mg. |
82 | M/s AstraZeneca Pharma India Limited | 19-01-2024 | IMP/BIO/24/000004 | Andexanet alfa | Andexanet alfa is indicated for patients treated with FXa inhibitors (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life- threatening or uncontrolled bleeding. | Dosage Form: Powder for solution for infusion. Strength: 200mg/ 20mL Vial |
83 | M/s. Lupin Limited | 19-01-2024 | IMP/BIO/24/000009 Note: Additional Marketing Authorization | Biphasic Isophane Insulin Injection I.P. (30% Soluble insulin and 70% Isophane insulin) (Note: The permission is granted to the firm additionally to the original MA holder M/s Eli Lilly) | For the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis. | Dosage Form: Suspension for injection in cartridge administered through subcutaneous route. Strength: 100IU/mL (3mL Cartridge) |
84 | M/s. Lupin Limited | 19-01-2024 | IMP/BIO/24/000008 Note: Additional Marketing Authorization | Isophane Insulin Injection I.P. (Note: The permission is granted to the firm additionally to the original MA holder M/s Eli Lilly) | For the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis | Dosage Form: Suspension for injection in cartridge administered through subcutaneous route. Strength: 100IU/mL (3mL Cartridge) |
85 | M/s Johnson and Johnson Private Limited | 15-02-2024 | IMP/BIO/24/000018 | Guselkumab | Guselkumab is indicated for the treatment of adult patients with active psoriatic arthritis | Dosage Form: Single-use pre-filled syringe & single- use pre-filled pen for subcutaneous administration. Strength: 100 mg/mL |
86 | M/s MSD Pharmaceutical s Private Limited | 06-03-2024 | IMP/BIO/24/000025 Note: Approval of Additional Indication. | Pembrolizumab | Additional Indication:
(ASCT) or following at least two prior therapies when ASCT is not a treatment option. | Dosage Form: Solution in single vial Strength: 25mg/mL |
87 | M/s Astrazeneca Pharma India Limited | 26-03-2024 | IMP/BIO/24/000035 Note: Approval of Additional Indication. | Trastuzumab deruxtecan | Additional Indication: Locally Advanced or Metastatic Gastric Cancer Trastuzumab deruxtecan is indicated for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab based regimen. | Dosage Form: Single use sterile, lyophilized powder for concentrate for solution for infusion Strength: 100mg/5mL |
88 | M/s Astrazeneca Pharma India Limited | 26-03-2024 | IMP/BIO/24/000036 Note: Approval of Additional Indication. | Trastuzumab deruxtecan | Additional Indication: HER2-Low Metastatic Breast Cancer Trastuzumab deruxtecan is indicated for the treatment of adult patients with unresectable or metastatic HER2-Low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemo therapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. | Dosage Form: Single use sterile, lyophilized powder for concentrate for solution for infusion Strength: 100mg/5mL |
89 | M/s Novartis Healthcare Private Limited | 26-03-2024 | IMP/BIO/24/000032 PAC- IMP/BIO/25/000147 for approval of additional pack presentation | Erenumab | Prophylaxis of migraine | Dosage Form: Solution for injection/prefilled pen. Strength: 70mg/mL |
90 | M/s. Lupin Limited | 08-04-2024 | IMP/BIO/24/000040 Note: Additional Marketing Authorization | Dulaglutide | Dulaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated:
multiple cardiovascular risk factors | Dosage Form: Solution for Injection in a single use prefilled pen. Strength: 0.75 mg/0.5 ml in Prefilled Pen and 1.5 mg/0.5 ml |
91 | M/s. Lupin Limited | 08-04-2024 | IMP/BIO/24/000038 Note: Additional Marketing Authorization | Insulin Lispro Injection I.P. | Treatment of patients with Diabetes Mellitus | Dosage Form: 3mL Cartridge and 3mL Prefilled Pen. |
92 | M/s. Lupin Limited | 09-04-2024 | IMP/BIO/24/000039 Note: Additional Marketing Authorization | Insulin Lispro Biphasic Injection I.P. (25% Insulin Lispro and 75% Insulin Lispro Protamine suspension) | Treatment of patients with Diabetes Mellitus. | Dosage Form: Suspension for injection in 3mL Cartridge & in 3mL prefilled pen Strength: 100 IU/mL |
93 | M/s. Lupin Limited | 09-04-2024 | IMP/BIO/24/000037 Note: Additional Marketing Authorization | Insulin Lispro Biphasic Injection I.P. (50% Insulin Lispro and 50% Insulin Lispro Protamine suspension) | Indicated for treatment of patients with Diabetes Mellitus. | Dosage Form: Suspension for injection in 3mL Cartridge & in 3mL prefilled pen. Strength: 100 IU/mL |
94 | M/s. Lupin Limited | 09-04-2024 | IMP/BIO/24/000041 Note: Additional Marketing Authorization | Insulin Human I.P. | Indicated for treatment of patients with Diabetes Mellitus. | Dosage Form: Concentrate solution for IV infusion in single use vial Solution for injection (Sub cutaneous) in pre-filled |
syringe. Strength: 100 IU/mL | ||||||
95 | M/s Johnson & Johnson Pvt. Ltd. | 16-04-2024 | BIO/IMP/20/000067 Note: Approval of Additional Indication | Ustekinumab | Ustekinumab is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis | Dosage Form: Suspension for injection in 3mL Cartridge. Strength: 130 mg/ 26 ml in vial 45 mg/0.5 ml, 90 mg/ml in PFS |
96 | M/s Dr. Reddy’s Laboratories Limited, | 10.05.2024 | IMP/BIO/24/000049 | Toripalimab |
| Dosage Form: Intravenous Solution for Infusion in 6mL vial. Strength: 240mg/6mL |
97 | M/s Bristol- Myers Squibb India Pvt. Ltd. | 22.05.2024 | IMP/BIO/24/000051 Note: Approval of Additional Indication | Nivolumab | Non-Small Cell Lung Cancer (NSCLC) - Nivolumab, in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumours ≥ 4cm or node positive) non-small cell lung cancer (NSCLC) | Dosage Form: concentrate for solution for infusion. Strength: 10 mg/ml |
98 | M/s Sanofi India Limited | 10.06.2024 | IMP/BIO/24/000058 | Nirsevimab | Nirsevimab Indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in:
vulnerable to severe RSV disease through their second RSV season. | Dosage Form: Solution for injection in pre-filled syringe Strength: 50mg/PFS and 100mg/PFS |
99 | M/s Eli Lilly And Company (India) Pvt. Ltd. | 09.07.2024 | IMP/BIO/24/000068 | Mirikizumab | Mirikizumab is indicated for the treatment of moderately to severely active ulcerative colitis in adults. | Dosage Form: Solution for subcutaneous administration in Pre-filled Pen Strength: 20mg/mL (300mg/15mL) in Vial and 100mg/mL in Pre-filled |
Pen | ||||||
100 | M/s Novartis Healthcare Private Limited | 30.07.2024 | IMP/BIO/24/000073 Note: Approval of Additional Indication | Secukinumab |
Secukinumab alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease-modifying anti- rheumatic drug (DMARD) therapy has been inadequate.
For the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.
Indicated for the treatment of active non- radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C- reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence in adults who have responded inadequately to non-steroidal anti- inflammatory drugs (NSAIDs). | Dosage Form: solution for injection in pre filled pen Strength: 150mg/mL |
101 | M/s AstraZeneca Pharma India Limited | 20.09.2024 | IMP/BIO/24/000085 Note: Approval of Additional Indication | Durvalumab | Durvalumab (IMFINZI) in combination with chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy after surgery, is indicated for the treatment of patients with resectable (tumours 4 cm and/or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. | Dosage Form: Solution for Infusion in Vial. Strength: 120 mg/2.4mL and 500mg/10mL (50mg/mL) |
102 | M/s AstraZeneca Pharma India Limited | 09.10.2024 | IMP/BIO/24/000094 Note: Approval of New Presentation | Benralizumab | Benralizumab is indicated as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype in adult patients. The recommended dose is 30 mg Benralizumab administered by subcutaneous injection every 4 weeks for the first 3 doses and then every 8 weeks thereafter. | Dosage Form: Solution for Injection in an Autoinjector Strength: 30mg/mL |
103 | M/s Bristol- Mayer Squibb India Pvt. Ltd. | 25.10.2024 | IMP/BIO/24/000098 Note: Approval of Additional Indication | Ipilimumab | Esophageal Squamous Cell Carcinoma (ESCC) Ipilimumab, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC)). | Dosage Form: concentrate for solution for infusion for intravenous injection, Single use vial Strength: 50mg/10mL (5mg/mL) |
104 | M/s Astrazeneca Pharma India Limited | 14.01.2025 | IMP/BIO/25/000001 | Eculizumab | For the treatment of patients with
| Dosage Form: Concentrate for solution for infusion in vial Strength: 300 mg (10mg/ml) |
105 | M/s Roche Products (India) Private Limited | 29.01.2025 | IMP/BIO/25/000008 Note: Approval of Additional Indication | Polatuzumab Vedotin | Polatuzumab vedotin in combination with bendamustine and rituximab is indicated for the treatment of adult patients with diffuse large B-cell lymphoma who have received at least one prior therapy | Dosage Form: Powder for concentrate for solution for infusion Strength: 30 mg/Vial and 140 mg/Vial |
106 | M/s Roche Products (India) Private Limited | 29.01.2025 | IMP/BIO/25/000007 Note: Approval of Additional Indication | Atezolizumab | Tecentriq as monotherapy is indicated for the first- line treatment of adult patients with advanced NSCLC who are ineligible for platinum-based therapy. | Dosage Form: Concentrate for solution for infusion Strength: 840mg/14ml vial |
107 | M/s Novo Nordisk India Pvt Ltd | 11.02.2025 | IMP/BIO/25/000010 | Insulin Icodec | Treatment of diabetes mellitus in adults. | Dosage Form: Solution for Injection in pre-filled pen Strength: 700U/1 mL, 1050U/1.5 mL & 2100 U/3 mL |
108 | M/s Novo Nordisk India Private Limited | 25.02.2025 | IMP/BIO/25/000014 Note: Approval of Additional Indication | Semaglutide Injection | Semaglutide Injection is indicated to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight. | Dosage Form: Solution for injection in prefilled pen (single dose and multi-dose pen injector) Strength: 0.25mg / 0.5mg / 1mg / 1.7mg / 2.4 mg |
109 | M/s AstraZeneca Pharma India Limited | 25.02.2025 | IMP/BIO/25/000016 Note: Approval of Additional Indication | Durvalumab | Durvalumab in combination with Tremelimumab is indicated for the treatment of patients with unresectable hepatocellular carcinoma (uHCC) | Dosage Form: Solution for Infusion. Strength: 120 mg/2.4mL and 500mg/10mL. |
110 | M/s MSD Pharmaceutical s Private Limited | 20.02.2025 | IMP/BIO/25/000015 | Sotatercept | Sotatercept in combination with standard pulmonary arterial hypertension (PAH) therapy, is indicated for the treatment of adults with PAH, (World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events. | Dosage Form: Powder for solution for injection in single dose vial. Strength: 45 mg & 60 mg Single-dose vial |
111 | M/s Astrazeneca Pharma India Limited | 06.03.2025 | IMP/BIO/25/000022 Note: Approval of Additional Indication | Durvalumab | Durvalumab is indicated for the treatment of patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT). | Dosage Form: Solution for Infusion. Strength: 120mg/2.4ml & 500 mg/10ml |
112 | M/s Roche Products (India) Pvt. Ltd. | 19.03.2025 | IMP/BIO/25/000026 | Crovalimab | Crovalimabis a complement C5 inhibitor indicated for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg. | Dosage Form: Solution for infusion in a single- dose vial Strength:340mg/2ml (170mg/ml) |
113 | M/s MSD Pharmaceutical s Private Limited | 21.04.2025 | IMP/BIO/25/000043 Note: Approval of Additional Indication | Pembrolizumab |
clinical studies) | Dosage Form: Solution for infusion Strength: 100 mg/4mL (25 mg/ml) |
114 | M/s Novo Nordisk India Private Limited | 28.04.2025 | IMP/BIO/25/000048 | Concizumab | Concizumab injection is indicated for routine prophylaxis of bleeding in patients with
| Dosage Form: Solution for Injection in pre-filled pen. Strength: 15mg/1.5mL, 60mg/1.5mL, 150mg/1.5mL and 300mg/3mL |
115 | M/s Glenmark Pharmaceutical s Ltd. | 02.05.2025 | IMP/BIO/25/000052 | Tislelizumab | 1. Tislelizumab as monotherapy is indicated for the treatment of adult patients with unresectable, recurrent, locally advanced or metastatic esophageal squamous cellcarcinoma (ESCC) after prior chemotherapy. Tislelizumab in combination with pemetrexed and platinum containing chemotherapy is indicated for the first-line treatment of patients with locally advanced or metastatic non- squamous non-small cell lung cancer (NSCLC), with PD-L1 expression ≥50% but no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations. Tislelizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of patients with locally advanced or metastatic squamous NSCLC. 4. Tislelizumab as monotherapy is indicated for the treatment of patients with locally advanced or metastatic NSCLC after prior chemotherapy | Dosage form: Concentrate for solution for infusion Strength: 100 mg/10ml, in Vial |
116 | M/s AstraZeneca Pharma India Limited | 07.05.2025 | IMP/BIO/25/000053 Note: Approval of Additional Indication | Trastuzumab Deruxtecan | HER 2 low and HER 2 ultralow breast cancer: Enhertu is indicated as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2- low (IHC 1+ and IHC 2+/ISH-) or HER2- ultralow (IHC0 with membrane staining) BC, who have received at least one endocrine therapy in metastatic setting | Dosage Form: Single use sterile, lyophilized powder for concentrate for solution for infusion Strength: 100 mg/ 5 ml |
117 | M/s Johnson & Johnson Pvt. Ltd., | 15.05.2025 | IMP/BIO/25/000057 Note: Approval of Additional Indication | Amivantamab | Amivantamab in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic non- small cell lung cancer(NSCLC) with activating epidermal-growth factor receptor (EGFR) Exon 20 insertion mutations | Dosage Form: Liquid concentrate for infusion. Strength: 350 mg |
118 | M/s AstraZeneca Pharma India Limited | 28.05.2025 | IMP/BIO/25/000066 Note: Approval of Additional Indication | Benralizumab | Benralizumab is indicated as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). | Dosage Form: Solution for injection Strength: 30mg/mL |
119 | M/s Johnson & Johnson Pvt. Ltd. | 30.05.2025 | IMP/BIO/25/000059 Note: Approval of Additional Indication | Ustekinumab | Ustekinumab injection indicated for the treatment of adult patients with moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. | Dosage Form: Solution for injection Strength: 45 mg/0.5 ml, 90 mg/ml in a single dose PFS. |
120 | M/s Bayer Pharmaceutic als Pvt. Ltd. | 30.05.2025 | IMP/BIO/25/000058 | Antihemophilic Factor (Recombinant Factor VIII) PEGylated-aucl 500IU, 1000IU, 2000IU & 3000IU | Indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for:
| Dosage Form: Lyophilized powder for solution for injection along with vial adapter Strength: 500IU, 1000IU, 2000IU & 3000IU |
121 | M/s Intas Pharmaceutical s Ltd, | 30.05.2025 | IMP/BIO/25/000065 | Serplulimab | Small Cell Lung Cancer: Serplulimab in combination with carboplatin and etoposide is indicated for the first-line treatment for adult patients with extensive stage small cell lung cancer (ES-SCLC) | Dosage Form: Concentrate for solution for infusion. Strength: 10 mg/ml |
122 | M/s AstraZeneca Pharma India Limited | 01.07.2025 | IMP/BIO/25/000077 Note: Approval of Additional Indication | Durvalumab | Durvalumab in combination with carboplatin and paclitaxel is indicated for the first line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy followed by maintenance treatment with Durvalumab in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR). | Dosage Form: Solution for Infusion. Strength: 120mg/2.4ml & 500 mg/10ml |
123 | M/s Sun Pharmaceutical Industries Limited | 02.07.2025 | IMP/BIO/25/000082 | Tildrakizumab Injection (r-DNA origin) | Indicated for the treatment of adults with moderate- to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. | Dosage Form: Single Dose Pre-filled Syringe with stalked needle and rigid needle shield and closed with a plunger stopper. Strength: 100mg/ml |
124 | M/s Bristol- Myers Squibb India Pvt. Ltd. | 04.07.2025 | IMP/BIO/25/000081 Note: Approval of Additional Indication | Luspatercept | Luspatercept is indicated in adults for the treatment of transfusion-dependentanaemia due to very low, low and intermediate-risk myelodysplastic syndromes. | Lyophilized Powder for solution for injection in vial. Strength: 25 mg and 75 mg |
125 | M/s Novartis Healthcare Private Limited | 04.07.2025 | IMP/BIO/25/000083 Note: Approval of Additional Indication | Secukinumab | Secukinumab is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy. | Dosage Form: solution for injection in pre filled pen Strength: 150mg/mL |
126 | M/s AstraZeneca | 11.07.2025 | IMP/BIO/25/000087 Note: | Durvalumab | Imfinzi in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent | Dosage Form: Solution for Infusion. |
Pharma India Limited | Approval of Additional Indication | IMFINZI as adjuvant treatment following radical cystectomy, for the treatment of adult patients with muscle invasive bladder cancer (MIBC) | Strength: 120mg/2.4ml & 500 mg/10ml | |||
127 | M/s Bayer Pharmaceutic als Pvt. Ltd. | 22.07.2025 | IMP/BIO/25/000088 | Antihemophilic Factor (Recombinant Factor VIII) I.P. 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU vial | Indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for:
| Dosage Form: Lyophilized powder for solution for injection along with vial adapter Additional Strength: 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU vial |
128 | M/s Pfizer Products India Private Limited | 25.07.2025 | IMP/BIO/25/000090 | Marstacimab | Indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with:
without factor IX inhibitors. | Dosage Form: Solution for Injection in pre-filled pen Strength: 150mg/ml |
129 | M/s Eisai Pharmaceutical s India Private Limited | 25.07.2025 | IMP/BIO/25/000091 | Lecanamab | To slow the progression of mild cognitive impairment and mild dementia due to Alzheimer’s disease. | Dosage Form: Concentrate for solution for infusion Strength: 100 mg/mL |
130 | M/s Pfizer Products India Private Limited | 22.08.2025 | IMP/BIO/25/000101 | Elranatamab | Indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least four prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. | Dosage Form: Solution for injection in a single dose vial. Strength: 44mg/1.1 mL (40mg/mL) and 76mg/1.9mL (40mg/mL) |
131 | M/s Bristol- Myers Squibb India Pvt. Ltd. | 26.08.2025 | IMP/BIO/25/000103 | FDC of Nivolumab and Relatlimab | For the treatment of adult & pediatric patients 12 years of age or older with unresectable or metastatic melanoma | Dosage form: Concentrate for Solution for Infusion. Strength: 240mg/80mg (r-DNA origin) in 20 ml |
132 | M/s Johnson & Johnson Pvt. Ltd. | 03.09.2025 | IMP/BIO/25/000108 Note: Approval of | Amivantamab | Amivantamab in combination with carboplatin and pemetrexed for the treatment of patients with locally advanced or metastatic NSCLC with | Dosage Form: Liquid concentrate for infusion. |
Additional Indication | EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with osimertinib | Strength: 350 mg | ||||
133 | M/s Biocon Biologics Limited | 18.09.2025 | IMP/BIO/25/000112 | Aflibercept |
impairment due to myopic choroidal neovascularisation. | Dosage Form: Solution for injection (Intravitreal use). Strength: 40 mg/ml |
134 | M/s Novo Nordisk India Private Limited | 19.09.2025 | IMP/BIO/25/000115 | Semaglutide Injection | Semaglutide injection is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus · To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease · To reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease. | Dosage Form: Solution for Injection in pre-filled pen Strength: 0.25 mg, 0.5 mg, 1 mg |
135 | M/s AstraZeneca Pharma India Limited | 30.09.2025 | IMP/BIO/25/000120 Note: Approval of Additional Indication | Trastuzumab Deruxtecan | Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder for concentrate for solution for infusion is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options | Dosage Form: Single use sterile, lyophilized powder for concentrate for solution for infusion Strength: 100 mg/ 5 ml |
136 | M/s Bristol- Myers Squibb India Pvt. Ltd. | 01.10.2025 | IMP/BIO/25/000116 Note: Approval of Additional Indication | Nivolumab | Nivolumab, in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by single-agent Nivolumab as adjuvant treatment after surgery. | Dosage Form: concentrate for solution for infusion. Strength: 10 mg/ml |
137 | M/s Ferring Pharmaceutical s Pvt. Ltd. | 03.10.2025 | IMP/BIO/25/000119 | Follitropin Delta | Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro | Dosage Form: Solution for Injection in a pre-filled pen for subcutaneous use |
fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle | Strength: 12mcg per 0.36mL, 36mcg per 1.08mL and 72mcg per 2.16 mL | |||||
138 | M/s Eli Lilly And Company (India) Pvt. Ltd. | 03.10.2025 | IMP/BIO/25/000117 | Donanemab | For the treatment of Alzheimer’s disease. Treatment with donanemab should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in the clinical trials | Dosage Form: Solution for intravenous infusion. Strength: 350 mg/20 mL (17.5 mg/mL) |
139 | M/s Johnson & Johnson Pvt. Ltd | 30.10.2025 | IMP/BIO/25/000130 Note: Approval of Additional Indication | Daratumumab | Daratumumab in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant. | Dosage Form- liquid for subcutaneous injection. Strength: 1800 mg (120 mg/mL). |
140 | M/s Bristol- Myers Squibb India Pvt. Ltd. | 17.11.2025 | IMP/BIO/25/000138 Note: Approval of Additional Indication | Nivolumab |
| Dosage Form: concentrate for solution for infusion. Strength: 10 mg/ml |
141 | M/s Bristol- Myers Squibb India Pvt. Ltd. | 17.11.2025 | IMP/BIO/25/000139 Note: Approval of Additional Indication | Nivolumab |
unresectable malignant pleural mesothelioma. | Dosage Form: concentrate for solution for infusion. Strength: 10 mg/ml |
142 | M/s MSD Pharmaceutical s Private Limited | 18.11.2025 | IMP/BIO/25/000141 Note: Approval of Additional Indication | Pembrolizumab | 1. KEYTRUDA® (pembrolizumab) in combination with chemoradiotherapy (external beam radiation therapy followed by brachytherapy), is indicated for the treatment of FIGO 2014 Stage III -IVA locally advanced cervical cancer in adults who have not | Dosage Form: Solution for infusion Strength: 100 mg/4mL (25 mg/ml) |
received prior definitive therapy.
| ||||||
143 | M/s Bristol- Mayer Squibb India Pvt. Ltd. | 24.11.2024 | IMP/BIO/25/000144 Note: Approval of Additional Indication | Ipilimumab |
line treatment of adult patients with unresectable malignant pleural mesothelioma. | Dosage Form: concentrate for solution for infusion for intravenous injection, Single use vial Strength: 50mg/10Ml (5mg/Ml) |
144 | M/s Sun Pharma Distributors Limited | 02.12.2025 | IMP/BIO/25/000150 | Tildrakizumab | Indicated for the treatment of adults with moderate- to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. | Dosage Form: Single Dose Pre-filled Syringe with stalked needle and rigid needle shield and closed with a plunger stopper. Strength: 100mg/ml |
145 | M/s GSK Pharma India Private Limited | 15.12.2025 | IMP/BIO/25/000160 | Dostarlimab | Dostarlimab is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with primary advanced or recurrent endometrial cancer (EC) who are candidates for systemic therapy | Dosage Form: Concentrate for solution for infusion (sterile concentrate) Strength: 500 mg/ 10 mL |
146 | M/s. Astrazeneca Pharma India Limited | 16.12.2025 | IMP/BIO/25/000159 | Datopotamab Deruxtecan | For the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)- positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and | Dosage Form: Powder for Concentrate for Solution for Infusion Strength: 100 mg |
chemotherapy for unresectable or metastatic disease | ||||||
147 | M/s Bristol- Mayer Squibb India Pvt. Ltd. | 19.12.2025 | IMP/BIO/25/000162 Note: Approval of Additional Indication | Ipilimumab |
patients. | Dosage Form: concentrate for solution for infusion for intravenous injection, Single use vial Strength: 50mg/10Ml (5mg/Ml) |
148 | M/s Astellas Pharma India Pvt. Ltd. | 19.12.2025 | IMP/BIO/25/000163 | Zolbetuximab | Zolbetuximab in combination with fluoropyrimidine and platinum- containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are Claudin (CLDN) 18.2 positive. | Dosage Form: Powder for concentrate for solution for infusion Strength: 100 mg and 300 mg |
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Susmita Roy, B pharm, M pharm Pharmacology, graduated from Gurunanak Institute of Pharmaceutical Science and Technology with a bachelor's degree in Pharmacy. She is currently working as an assistant professor at Haldia Institute of Pharmacy in West Bengal. She has been part of Medical Dialogues since March 2021.
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