CDSCO Clears Over 100 rDNA Drugs and Biologics Between 2020-25, Boosting Access to Advanced Therapies
New Delhi: India's drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has approved a wide range of recombinant DNA (r-DNA)-origin drugs and biologics for manufacture and marketing in the country between January 2020 and December 2025, marking a significant step toward improving access to advanced and life-saving therapies.
The approvals cover both finished formulations and bulk drug substances of several high-value biologics used in critical disease areas. These include monoclonal antibodies, recombinant hormones, growth factors, insulin analogues, and immunotherapies such as Omalizumab, Ranibizumab, Itolizumab, Etanercept, Trastuzumab, Denosumab, Bevacizumab, Adalimumab, Ustekinumab, Golimumab, Tocilizumab, Tenecteplase, Insulin analogues, and Erythropoietin, among others.
Several products also received additional or revised indications, expanding their approved clinical use in India. Recombinant DNA (rDNA) technology produces crucial protein-based drugs like insulin, human growth hormone, interferons, erythropoietin, and clotting factors by inserting human genes into microbes, creating "bio-engineered" medicines for diabetes, cancers, anemia, and dwarfism, plus vaccines like Hepatitis B, offering safer, cheaper alternatives to animal-derived sources. It also enables development of monoclonal antibodies (mAbs) for targeted therapies (e.g., cancer, autoimmune diseases) and advanced vaccines, revolutionizing treatment for many chronic and infectious conditions.
An analysis of CDSCO CT-21 approvals granted in 2025 indicates that multiple Indian biopharmaceutical companies received permissions primarily for manufacture for sale and distribution in India, along with approvals for drug substance and finished formulations of recombinant DNA–origin biologics. Reliance Life Sciences Pvt. Ltd. was granted CT-21 approval for the manufacture and marketing of Denosumab injection for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. Intas Pharmaceuticals Ltd. received approval for the manufacture of Pertuzumab (drug substance as well as drug product) intended for the treatment of HER2-positive Metastatic Breast Cancer and Pertuzumab is indicated in combination with trastuzumab and docetaxel for patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not yet received any chemotherapy for their metastatic disease.
In January 2025, Shilpa Biologicals Pvt. Ltd. obtained CT-21 clearance for the manufacture and sale of Adalimumab injection for additional therapeutic indications, expanding its approved use to psoriasis, Crohn’s disease, ulcerative colitis, and hidradenitis suppurativa.
Additionally, Eris Lifesciences Ltd. received multiple CT-21 approvals during 2025 for the manufacture and sale of insulin and insulin analogue formulations, including regular insulin and long-acting insulin preparations, indicated for the management of diabetes mellitus where insulin therapy is required.
List of new drugs (r-DNA origin) approved for manufacture 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 Reliance Life Sciences Pvt. Ltd. | 21-02-2020 | MF/BIO/20/000009 | Omalizumab powder for solution for Injection | Asthma Omalizumab is indicated for adult patients with moderate to severe persistent asthma who have a positive skin test or invitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. Limitations of Use: | Dosage Form: Lyophilized Powder for solution for Injection; Strength: 150 mg. Omalizumab powder for solution for Injection (subcutaneous route) 1. Single Use Vial (Single vial containing lyophilized product in the strength of 150 mg) 2. Combikit |
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Chronic Idiopathic Urticaria (CIU) | ||||||
Omalizumab is indicated for the treatment of adult patients with chronic idiopathic urticaria who remain symptomatic despite H1 antihistamine treatment. | ||||||
Limitation of Use: | ||||||
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2 | M/s Reliance Life Sciences Pvt. Ltd. | 26-02-2020 | MF/BIO/20/000011 | Omalizumab (new bulk drug substance) (90.00 mg/ml to 110.00 mg/ml) | Not applicable | Omalizumab (new bulk drug substance) (90.00 mg/ml to 110.00 mg/ml) |
3 | M/s Reliance Life Sciences Pvt. Ltd | 30-03-2020 | MF/BIO/20/000024 | Ranibizumab Injection | Indicated for the Neovascular (Wet) Age-Related Macular Degeneration (AMD). | Dosage Form: Solution for Injection in vial. |
Strength: Ranibizumab | ||||||
0.5 mg -10mg/ml (2.3 | ||||||
mg/0.23ml) - | ||||||
Ranibizumab 0.3 mg - | ||||||
6mg/ml (1.38 mg /0.23 | ||||||
ml) 1. Single Use Vial (Single vial containing of 0.5 mg or o.3 mg Ranibizumab) 2. Combikit | ||||||
4 | M/s Reliance Life Sciences Pvt. Ltd | 3-04-2020 | MF/BIO/20/000026 | Ranibizumab bulk drug substance | Not applicable | Ranibizumab bulk drug substance 12 mg/mL to 18 mg/mL |
5 | M/s USV Private Limited | 13-04-2020 | MF/BIO/20/000030 | Pegfilgrastim bulk drug substance | Not applicable | Pegfilgrastim bulk drug substance |
6 | M/s Biocon Biologics India Limited | 21-09-2020 | MF 378/2012 | Itolizumab Injection (r- DNA origin) 100 mg/vial lyophilized powder |
| Lyophilized powder for i.v injection. Each vial of Itolizumab Injection is reconstituted with approximately 1.1 mL of sterile water for injection. This results in a protein concentration of approximately 100 mg/mL Strength: 100mg/mL |
the treatment of Cytokine Release Syndrome | ||||||
(CRS) in moderate to severe Acute | ||||||
Respiratory Distress Syndrome (ARDS) | ||||||
patients due to COVID-19 | ||||||
7 | M/s Biocon Biologics India Limited | 22-09-2020 | BULK - 377/2012 | Itolizumab bulk drug substance (r-DNA origin) | Not applicable | Itolizumab bulk drug substance (r-DNA origin) 27±2 mg/mL, inhouse specification |
8 | M/s Mylan Pharmaceutical s Private Limited | 07-01-2021 | MF/BIO/21/000005 | Etanercept | Rheumatoid Arthritis (RA)–□Etanercept in | Dosage Form: Solution for subcutaneous Injection (single use) |
combination with methotrexate is indicated for | ||||||
the treatment of moderate to severe active | ||||||
rheumatoid arthritis in adults when the response to | ||||||
disease-modifying antirheumatic drugs, | ||||||
including methotrexate (unless contraindicated), | ||||||
has been inadequate.□Etanercept can be given | ||||||
as monotherapy in case of intolerance to | ||||||
methotrexate or when continued treatment with | ||||||
methotrexate is inappropriate□Etanercept is also | ||||||
indicated in the treatment of severe, active and |
progressive rheumatoid arthritis in adults not previously treated with methotrexate. □Etanercept, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical functionJuvenile Idiopathic Arthritis (JIA) – □Treatment of polyarthritis (rheumatoid factor positive or negative)and extended oligoarthritis in children and adolescents from the age of 2 years who have had aninadequate response to, or who have proved intolerant of, methotrexate.□Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.□Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.□Etanercept has not been studied in children aged less than 2 years.Psoriatic Arthritis (PsA) –Treatment of active and progressive psoriatic arthritis in adults when the response to previous diseasemodifying antirheumatic drug therapy has been inadequate. Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.Axial spondyloarthritisAnkylosing Spondylitis (AS)– Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.Nonradiographic Axial Spondyloarthritis (nr-AxSpA)-Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal | Strength: Pre- filled syringe:(i)50 mg/mL in Prefilled Syringes (ii) 25 mg /0.5 mL in Pre- filled Syringes Pre-filled Pen: (i). 50 mg/mL Pre-filled pen |
anti-inflammatory drugs (NSAIDs).Plaque Psoriasis (PsO) -Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralenand ultraviolet-A light (PUVA).Pediatric Plaque Psoriasis-Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. | ||||||
9 | M/s Mylan Pharmaceutica l Private Limited | 11-01-21 | Bulk-BIO/03/2021 | Etanercept drug substance (r- DNA origin) | NA | Protein Concentration 50 ± 5 mg/mL |
10 | M/s Cadila Healthcare Limited | 12-01-2021 | MF/BIO/21/000008 | Trastuzumab emtansine, bulk | NA | Trastuzumab emtansine (r-DNA origin) Bulk drug substance; (Protein Concentration18.00 –22.00 mg/mL), in-house specification |
11 | M/s Enzene Biosciences Limited | 28-01-2021 | MF/BIO/21/000014 | Teriparatide | Teriparatide is indicated in adults. Treatment of osteoporosis in postmenopausal women | i) Teriparatide Injection 600mcg/ 2.4 mL Pack style – 1 Disposable Pen of 600 mcg/2.4 mL (ii) Teriparatide Injection 750mcg/ 3 mLReusable pen with cartridge in blisters |
12 | M/s Cadila Healthcare Limited | 23-04-21 | MF-266/11, dated 21.06.2011 | Pegylated Interferon alfa- 2b | Additional indication - Restricted Emergency Use in the country in emergency situation in the treatment of moderate COVID-19 infection in adults | Pegylated Interferon alfa- 2b for Injection (r-DNA origin) 50 µg/0.5ml, 80 µg/0.5ml, 100 µg/0.5ml, 120 µg/0.5ml and 150 µg/0.5ml powder for concentrate for solution for infusion in single use vial (lyophilized vial for |
subcutaneous) | ||||||
13 | M/s Epygen Biotech Private Limited | 21-05-21 | MF/BIO/21/000046 | Biphasic Isophane Insulin Injection IP | Treatment of Diabetes mellitus | Dosage form: Suspension for Injection for subcutaneous administration Strength: 40 IU/ml, 10 mL vials |
14 | M/s Enzene Biosciences Ltd | 01-07-21 | MF/BIO/21/000056 | Romiplostim injection | Romiplostim is indicated for the treatment of primary immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). | Dosage Form: Lyophilized powder for solution for injection in single use vial to be used as solution for Injection for subcutaneous use after reconstitution Strength: Romiplostim Injection (r-DNA Origin) 125 mcg/vial, 250 mcg/vial and 500 mcg/vial |
15 | M/s Enzene Biosciences Ltd | 01-07-21 | MF/BULK/BD/190/2 021 | Recombinant Romiplostim drug substance | NA | Recombinant Romiplostim drug substance 0.50 ± 10% mg/mL (0.45 to 0.55 mg/mL) |
16 | M/s Enzene Biosciences Ltd., Plot No. 165/1/26, Block ‘T’, Bhosari M.I.D.C Area, Bhosari, Pune – 411026, Maharashtra, India | 20-07-2021 | MF/BIO/21/00006 2 | Denosumab 60mg/ml (r- DNA origin) | Denosumab is indicatedfor the treatment of osteoporosis in postmenopausal women. | solution for subcutaneous Injection inprefilled syringe Concentration: 60mg/ml |
17 | M/s Enzene Biosciences | 20-07-2021 | MF/BULK/BD/21 1/2021 | Denosumab (r- DNA origin) | NA | Concentration: 90 ± 20 mg/mL (70 to |
Ltd., Plot No. 165/1/26, Block ‘T’, Bhosari M.I.D.C Area, Bhosari, Pune – 411026, Maharashtra, India | drug substance | 110 mg/mL) | ||||
18 | M/s Bharat Serums and Vaccines Limited, 17th Floor, Hoechst House, NarimanPoi nt, Mumbai (India) - 400021 | 16-08-2021 | NOC for additional Strength & presentation-Pre Filled Syringe (PFS)vide F.No. BIO/MA/21/00005 2 | Recombinant Human Follicle Stimulating Hormone I.P. | For the treatment of an ovulation in women, non-responsive toclomiphene citrate. | Dosage Form: Solution for Injection in Prefilled Pen for multidose usage Strength:450 IU/0.75ml |
19 | M/s Bharat Serums and Vaccines Limited, 17th Floor, Hoechst House, NarimanPoi nt, Mumbai (India) - 400021 | 16-08-2021 | NOC for additional Strength BIO/MA/21/00005 | Recombinant Human Follicle Stimulating Hormone I.P. | For the treatment of an ovulation in women, non-responsive toclomiphene citrate. | Dosage Form: Solution for Injection in Prefilled Pen for multidose usage Strength: 900 IU/1.5mL |
20 | M/s. Intas Pharmaceu ticals Ltd Corporate House, Near Sola Bridge S.G. Highway, | 22-08-2021 | MF/BIO/21/00008 3 | Denosumab |
that is unresectable or where surgical | Dosage Form: Solution for injection in vial Strength: 70 mg/ml |
Thaltej Ahmedaba d Gujarat (India) – 380054 | resection is likely to result in severe morbidity,
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21 | M/s Bharat Serums and Vaccines Limited, 17th Floor, Hoech st House, Narim an Point, Mumbai – 400 021, Maharashtra, India | 24-08-2021 | NOC for additional strength vide F. No. BIO/MA/21/00004 6 | Recombinant Anti Rho-D Immunoglobulin | Indicated to prevent Rh Negative Women from forming antibodies to foetal rhesus positive red blood cells, that may pass in to the maternal blood during child birth, abortion or certain other sensitizing events | Dosage Form: Solution for injection for intramuscular administration only Strength: 150 mcg in 2 ml Vial |
22 | M/s Biopharma Limited, H.No. 8-3- 166/1 & 2, 105 to 108, 1st Floor, G Block, East Wing, Challa Hyderabad - 500018, Telangana, India | 03-09- 2021 | MF/BULK/BD/25 9 /2021 | Tocilizumab drug substance (r-DNA origin) | NA | Concentration: 20 mg/mL |
23 | M/s Biopharma 105 to 108, 1st Floor, G Block, East Wing, Challa | 03-10-2021 | MF/BIO/21/00010 4 | Tocilizumab | Indicated for Restricted use of thedrug under emergency situation in the country to treat COVID-19 hospitalizedadults who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) | Dosage Form: Concentrate for solution for infusion in single use vial Strengths -
|
24 | M/s Lupin Limited, Kalpataru Inspire, 3rd Maharashtra, India | 29-10-2021 | MF/BULK/BD/31 4/2021 | Ranibizumab drug substance (r-DNA origin) | NA | Concentration: 9.5 –11 mg/mL |
25 | M/s Lupin Limited, Kalpataru Inspire, 3rd Maharashtra, India | 29-10-2021 | MF/BIO/21/00011 9 | Ranibizumab | Indicated for the treatment of neovascular (wet) age – related macular degeneration (AMD) | Dosage Form: Solution for intravitreal injection in vial Strength – 10 mg/mL |
26 | M/s Biogenomics Limited, First Floor, Kothari Compound, Opposite Tiku-ji-ni- wadi, Maharashtra, India | 29-10- 2021 | MF/BULK/BD/31 2/2021 | Recombinant Insulin Aspart I.P. (r-DNA origin) drug substance | NA | lyophilized powder |
27 | M/s Biogenomics Limited, First Floor, Kothari Compound, Opposite Tiku-ji-ni- wadi Mandapa, Thane West - 400610, Maharashtra , India | 29-10-2021 | MF/BIO/21/00012 0 | Recombinant Insulin Aspart I.P. | Indicated for treatment of diabetes mellitus (DM) in adults | Dosage Form: Solution for injection Strength - 100 U/mL or 3.5 mg/mL of Insulin aspart in 3 mL cartridge and 10 mL vial |
28 | M/s Cadila Healthcare Limited | 30.12.2020 | MF/BIO/20/000102 | Trastuzumab Emtansine | 1) Metastatic Breast Cancer (MBC) for the treatment of HER2-positive, unresectable locally advanced or metastatic breast cancer, in patients who had previously received trastuzumab and a | Dosage Form: Lyophilized Powder for concentrate for solution for Intravenous infusion in |
taxane, separately or in combination. Such patients should have either i) received prior therapy for locally advanced or metastatic disease, or ii) developed a disease recurrence during or within six months of completing adjuvant therapy. 2) Early Breast Cancer (EBC) for the adjuvant treatment of patients with HER2-positive early breast cancer with residual invasive disease in the breast and/or lymph nodes after receiving neo-adjuvant taxanebased and HER2-targeted therapy | Vial Strength: 100 mg and 160 mg | |||||
29 | M/s Virchow Biotech Pvt Ltd., Plot No: 4, SV Cooperativ e, Industrial Estate, Jeedimetla Medchal – Malkajgiri (D), Telangana - 500055, India | 29-12-2021 | MF/BIO/21/00014 0 | Pegylated Recombinant Human Granulocyte Colony Stimulating factor injection | Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the expectation of chronic myeloid leukemia and myelodysplasticsyndromes). | Dosage Form: Solution for injection in pre- filled syringe Strength - 6mg/0.6ml. |
30 | M/s Dr Reddys Laboratories Limited, Survey No. 47, Bachupally Village, Bachupally Mandal, Hyderabad (India) – 500090 | 29-12-2021 | MF/BIO/21/00014 1 | Rituximab (r- DNA origin) Bulk FDS | NA | Frozen or liquid condition |
31 | M/s Bharat Serums and Vaccines Limited, 17th | 19-01-2022 | NOC vide F. No. BIO/MA/21/00005 4 | Recombinant Human Follicle Stimulating Hormone | For the treatment of an ovulation in women, non-responsive toclomiphene citrate. | Dosage Form: Solution for injection in prefilled pen(Multidose) |
Floor, Hoechst House, NarimanPoi nt, Mumbai (India) - 400021 | Strength - 1200 I.U. / 2.0 mL | |||||
32 | M/s Dr Reddys Laboratories Limited, Survey No. 47, Bachupally Village, Bachupally Mandal, Hyderabad (India) – 500090 | 20-04-2022 | MF/BIO/22/00003 0 | Bevacizumab Formulated Drug Substance in Liquid and Frozen form (r- DNA origin) | NA | Concentration: 25 mg/mL |
33 | M/s Anamay Biotech Private Limited, 2, Padmja | 23-05-2022 | MF/BIO/22/00004 5 | Recombinant Human Epidermal Growth Factor Aqueous Bulk | NA | Concentration: NLT 500 μg in 1mL |
34 | M/s Anamay Biotech Private Limited, 2, Padmja | 23-05-2022 | MF/BIO/22/00004 6 | Recombinant Human Epidermal Growth Factor, Silver Sulfadiazine and Chlorohexidine Gluconate Cream | For the Treatment of burns | Dosage Form: Topical Cream Strength: Quantity per gram: · Recombinant Human Epidermal Growth Factor - 10mcg,
|
35 | M/s Anamay Biotech Private Limited, 2, | 24-05-2022 | MF/BIO/22/00004 8 | Recombinant Human Epidermal Growth Factor | indicated for the topical healing of diabetic foot ulcers, donor site skin grafts and burn wounds | Dosage Form: Topical gel Strength: 10 μg, |
Padmja | 60 μg and 150 μg Topical gel | |||||
36 | M/s Lupin Limited, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai – 400055, Maharashtra, India | 17-06-2022 | NOC for additional indications vide F. No. BIO/MA/22/00003 1 | Ranibizumab |
3. The treatmentof visual impairment dueto choroidalneovascularization (CNV) secondary topathologic myopia (PM) | Dosage Form: Solution for injection in Vial Strength: 10 mg/ml |
37 | M/s Intas Pharmaceuti calsLimited | 06-07-2022 | PAC for additional indication vide F.No. 4-93/Intas/ PAC-R- Ranibizumab/202 1-BD | Ranibizumab | Ranibizumab is indicated in preterm infants for the treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), Zone II (Satge 3+) or AP-ROP (aggressive posterior ROP) disease”. | Dosage Form: Solution for injection in vial Strength: 10 mg/mL |
38 | M/s Bharat Serums and Vaccines Limited, 17th Floor, Hoechst House, India | 22-08-2022 | NOC for new strength vide F. No. BIO/MA/22/00006 0 | Recombinant Human Follicle Stimulating Hormone | For the treatment of an ovulation in women, non-responsive toclomiphene citrate. | Dosage Form: Solution for Injection in Prefilled Pen for multidose usage Strength: 300 IU/0.5ml |
39 | M/s Bharat Serums and Vaccines Limited,17th | 29-09-2022 | NOC for additional presentation-Pre Filled Syringe (PFS)vide F. No. BIO/MA/21/00011 5 | Recombinant Anti Rho-D Immunoglobulin | r-anti-D is indicated to prevent Rh Negative Women from forming antibodies to foetal rhesus positive red blood cells, that may pass in to the maternal blood during child birth, abortion or certain other sensitizing events. | Dosage Form: Solution for injection in Pre- filled syringe for intramuscular administration only Strength: 150 mcg / 1mL |
40 | M/s Enzene Biosciences Ltd. | 28-10-2022 | MF/BIO/22/000100 | Adalimumab (r-DNA Origin) | Adalimumab is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. | Dosage Form: Solution for injection in PFS. Strength: 100 mg/mL |
41 | M/s Enzene Biosciences Ltd. | 08-12-2022 | MF/BIO/21/000014 | Teriparatide |
osteoporosis therapy. | Dosage Form: Solution for subcutaneous Injection Strength: 600 mcg/2.4ml and 750 mcg/3ml |
42 | M/s Reliance Life Sciences Private Limited | 19-12-2022 | MF/BIO/22/000133 | Denosumab (r-DNA Origin) | Denosumab is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. | Dosage Form: Solution for subcutaneous injection in PFS & vial. Strength: 60 mg/ml |
43 | M/s Enzene Biosciences Ltd. | 16-01-2023 | MF/BIO/23/000001 | Cetuximab | Squamous cell cancer of the head and neck. | Dosage Form: Solution for Intravenous Infusion in vial Strength: 100 mg/20 ml |
44 | M/s. Hetero Biopharma Limited | 31-01-2023 | MF/BIO/23/000004 | Tenecteplase | Tenecteplase is indicated in adults for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left Bundle Branch Block within 6 hours after the onset of acute myocardial infarction (AMI) symptoms | Dosage Form: Lyophilized powder for injection in vial Strength: 30 mg/6 ml, 40 mg/8 ml, 50 mg/10 ml |
45 | M/s Wockhardt Limited | 14-02-2023 | MF/BIO/23/000006 | Erythropoietin | Anaemia associated with chronic renal failure in haemodialysis in adults or peritoneal dialysis and non- dialysed adults | Dosage Form: Solution for injection in PFS. Strength: 4000IU, 5000IU, 10000IU |
46 | M/s Enzene Biosciences Ltd. | 21-02-2023 | MF/BIO/23/000011 | Bevacizumab | Bevacizumab in combination with fluoropyrimidine- based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum | Dosage Form: Concentrate for solution for infusion in Vial Strength: 25 mg/ml |
47 | M/s Sun Pharmaceutical Industries Limited | 24-03-2023 | MF/BIO/23/000020 | Ranibizumab | Indicated for the treatment of neovascular age-related macular degeneration (AMD) | Dosage Form: Single-use glass vial for intravitreal injections Strength: 10 mg/mL |
48 | M/s Enzene Biosciences Ltd. | 10-04-2023 | MF/BIO/23/000031 | Denosumab injection |
high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer | Dosage Form: Pre-filled syringe Strength: 60 mg/ml |
49 | M/s Reliance Life Sciences Pvt. Ltd. | 26-04-2023 | MF/BIO/23/000038 | Golimumab Injection | Golimumab in combination with methotrexate (MTX), is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis | Dosage Form: Solution for injection in Single use prefilled syringe for subcutaneous injection. Strength: 50 mg/0.5 mL and 100 mg/mL |
50 | M/s Reliance Life Sciences Pvt. Ltd. | 26-04-2023 | MF/BIO/23/000037 | Ustekinumab | Ustekinumab is indicated for the treatment of adult patients with moderate to severe plaque psoriasis. | Dosage Form: Solution for injection in Single use prefilled syringe for subcutaneous injection. Strength: 45 mg/0.5 mL and 90 mg/mL |
51 | M/s Reliance Life Sciences Pvt. Ltd. | 16-05-2023 | MF/BIO/23/000046 | Ustekinumab Drug Substance (Bulk) | NA | Concentration: 95.00 to 125.00 mg/mL |
52 | M/s Reliance Life Sciences Pvt. Ltd. | 16-05-2023 | MF/BIO/23/000047 | Golimumab Drug Substance (Bulk) | NA | Concentration: NLT 110 mg/mL |
53 | M/s Shilpa Biologicals Private Limited | 22-06-2023 | MF/BIO/23/000057 | Adalimumab | Adalimumab is indicated for Rheumatoid Arthritis (RA) (in adults)
• Severe, active and progressive RA | Dosage Form: Solution for Injection (Single use prefilled syringe for subcutaneous injection) Strength: 40 mg/0.4 mL |
54 | M/s Shilpa Biologicals Private Limited | 24-08-2023 | MF/BIO/23/000078 | Adalimumab Drug Substance (Bulk) | NA | Concentration: 100 mg/ml |
55 | M/s Enzene Biosciences | 29-08-2023 | MF/BIO/23/000080 | Ranibizumab Injection | Neovascular Age related Macular Degeneration | Dosage Form: Solution for injection in |
Ltd. | vial Strength: 10 mg/ml | |||||
56 | M/s Levim Biotech LLP | 24-08-2023 | MF/BIO/23/000076 | Liraglutide | For the treatment of Type II Diabetes Mellitus. | Dosage Form: Solution for Injection in 3 ml cartridge (18mg/3mL) Strength: 10 mg/mL |
57 | M/s Zenotech Laboratories Limited | 05-10-2023 | MF/BIO/23/000089 | Ranibizumab | Indicated for the treatment of neovascular age- related macular degeneration (AMD)” | Dosage Form: Single- use glass vial for intravitreal injections Strength: 10 mg/ml |
58 | M/s Gennova Biopharmace uticals Limited | 27-10-2023 | MF/BIO/23/000093 | Tenecteplase | Revision of Approved Indication: Tenecteplase (TNK-t-PA) is indicated in thrombolytic treatment of the Acute Ischemic Stroke within 4.5 hrs of the stroke initiation | Dosage Form: powder for injection. Strength: 20 mg/10mL Vial |
59 | M/s Reliance Life Sciences Pvt. Ltd. | 29-11-2023 | MF/BIO/23/000098 Note: Approval of Additional Indication. | Bevacizumab | Additional Indication: Hepatocellular Carcinoma (HCC) -Bevacizumab in combination with Atezolizumab for the treatment of patients with unresectable or metastatic HCC who have not received prior systemic therapy. | Dosage Form: Solution for infusion. Strength: 100 mg/4mL & 400mg/16mL |
60 | M/s Enzene Biosciences Ltd. | 08-01-2024 | MF/BIO/24/000002 | Ranibizumab Drug Substance | NA | Concentration: 13 mg/mL ±10% |
61 | M/s Sun Pharmaceuti cals Industries Limited | 18-01-2024 | MF/BIO/24/000006 Note: Approval of Additional Indication. | Ranibizumab | Additional Indication:
| Dosage Form: Single-use glass vial for intravitreal injections Strength: 10 mg/mL |
62 | M/s M.J. Biopharm Pvt. Ltd | 19-01-2024 | MF/BIO/24/000011 | Liraglutide | For the treatment of Type II Diabetes Mellitus. | Dosage Form: Single- use glass vial for intravitreal injection Solution for Injection in 3 ml cartridge Strength: 18 mg/3mL |
63 | M/s Enzene Biosciences Ltd. | 30-01-2024 | MF/BIO/24/000014 Note: Approval of Additional Indication. | Bevacizumab | Additional Indication:
| Dosage Form: Concentrate for solution for infusion in Vial. Strength: 100mg/4mL & 400 mg/16mL |
topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents.
not received prior systemic therapy. | ||||||
64 | M/s M.J. Biopharm Pvt. Ltd | 27-03-2024 | MF/BIO/24/000039 | Recombinant Insulin Glargine, Drug Substance IP/USP/Ph. Eur | NA | NA |
65 | M/s M.J. Biopharm Pvt. Ltd | 27-03-2024 | MF/BIO/24/000037 | Insulin Glargine Injection | For the treatment of patients diagnosed with Type 2 Diabetes Mellitus | Dosage Form: Solution for Injection in 10 ml vial and 3 ml cartridge Strength: 100 IU/mL |
66 | M/s Curateq Biologics Private Limited | 27-03-2024 | MF/BIO/24/000036 | Trastuzumab(r- DNA origin) drug substance | NA | Concentration: 22mg/ml±1mg/ml (Frozen liquid) and 25mg/ml ±2mg/ml (Frozen liquid) |
67 | M/s Curateq Biologics Private Limited | 27-03-2024 | MF/BIO/24/000036 | Trastuzumab | For the treatment of HER2-positive metastatic breast cancer | Dosage Form: Powder for concentrate for Solution for Infusion. Strength: 150mg/vial & 420mg/vial |
68 | M/s Zydus Lifesciences Limited | 04-04-2024 | MF/BIO/24/000041 | Pertuzumab | For the treatment of metastatic breast cancer | Dosage Form: Single dose vial of concentrate solution for intravenous infusion |
Strength: 420mg/14mL (30mg/mL) | ||||||
69 | M/s Enzene Biosciences Ltd. | 29-04-2024 | MF/BIO/24/000046 Note: Approval of Additional Indication | Adalimumab Injection | 1.Rheumatoid arthritis 2.Psoriatic arthritis 3.Hidradenitis suppurativa (HS) 4.Crohn's disease 5.Ulcerative colitis 6.Psoriasis 7. Juvenile idiopathic arthritis | Dosage Form: Strength: 20 mg/ 0.2 mL PFS, 40 mg/ 0.4 mL PFS, 80 mg/ 0.8 mL PFS (100mg/mL) |
70 | M/s Biocon Biologics Limited | 30-04-2024 | MF/BIO/24/000047 Note: Due to change of MA holder | Etanercept Injection | Rheumatoid Arthritis (RA) –
severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function Juvenile Idiopathic Arthritis (JIA) –
| Dosage Form: Solution for subcutaneous Injection (single use) Strength: 50mg/mL & 25mg/0.5mL in PFS and 50mg/mL in PFP |
less than 2 years. Psoriatic Arthritis (PsA) – Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease modifying antirheumatic drug therapy has been inadequate. Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease. Axial spondyloarthritis Ankylosing Spondylitis (AS) –Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Nonradiographic Axial Spondyloarthritis (nr- AxSpA) -Treatment of adults with severe non- radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C- reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti- inflammatory drugs (NSAIDs). Plaque Psoriasis (PsO) -Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet- A light (PUVA). Pediatric Plaque Psoriasis -Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. | ||||||
71 | M/s Biocon Biologics Limited | 30-04-2024 | MF/BIO/24/000047 Note: Due to change of MA holder | Etanercept (r- DNA origin) drug substance (bulk); | Not Applicable | Composition: 45.00 mg/mL to 55.00 mg/mL, in-house specification |
72 | M/s Reliance Life Sciences Pvt Ltd | 09.07.2024 | MF/BIO/24/000077 Note: Approval of Additional Indication | Ranibizumab |
| Dosage Form: solution for injection in vial Strength: 2.3mg/0.23mL (0.5mg dose) and 1.38mg/0.23mL (0.3mg |
dose) | ||||||
73 | M/s Zydus Lifesciences Limited | 27.08.2024 | MF/BIO/24/000091 Note: Approval of Additional Indication | Pertuzumab | Early Breast Cancer | Dosage Form: Concentrate solution for intravenous infusion in vial Strength: 420 mg/14 mL (30mg/mL) |
74 | M/s Bharat Serums And Vaccines Limited | 15.10.2024 | MF/BIO/24/000107 Note: Revised Indication | Trinbelimab | Trinbelimab Injection (r-anti-D) is indicated to prevent Rh negative women from forming antibodies to foetal Rh positive red blood cells, that may pass into the maternal blood during pregnancy, childbirth, abortion or certain other sensitizing events | Dosage Form: Solution for Injection in Vial and PFS Strength: 300 mcg & 150 mcg |
75 | M/s Reliance Life Sciences Pvt Ltd | 25.10.2024 | MF/BIO/24/000111 Note: Approval of Additional Indication | Golimumab |
| Dosage Form: Solution for injection in PFS. Strength: 50mg/0.5ml and 100mg/ml |
76 | M/s Cadila Pharmaceuti cals Limited | 27.11.2024 | MF/BIO/24/000126 | Biphasic Isophane Insulin Injection (30/70) IP | For the treatment of Diabetes Mellitus in patients who requires injectable insulin. | Dosage Form: Solution for injection in Vial. Strength: 40IU/mL |
77 | M/s. Hetero Biopharma Limited | 20.12.2024 | MF/BIO/24/000132 | Denosumab | Denosumab 120 mg/ 1.7 ml (70 mg/mL) (r-DNA origin) is indicated for- 1. Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone. | Dosage Form: Subcutaneous (SC) Injection in Vial. Strength: 70mg/mL |
2. Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity | ||||||
78 | M/s Reliance Life Sciences Pvt. Ltd. | 23.12.2024 | MF/BIO/24/000133 Note: Approval of Additional Indication | Ustekinumab |
UstekiRel® is indicated for the treatment of adult patients with active psoriatic arthritis. UstekiRel® can be used alone or in combination with methotrexate (MTX).
UstekiRel® is indicated for the maintenance treatment of adult patients with moderately to severely active Crohn's disease.
UstekiRel® is indicated for the maintenance treatment of adult patients with moderately to severely active ulcerative colitis | Dosage Form: Solution for injection in PFS. Strength: 45 mg/0.5ml & 90 mg/ml |
79 | M/s Zydus Lifesciences Limited | 27.12.2024 | MF/BIO/24/000136 | Nivolumab |
Nivolumab, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by a validated test, with no EGFR or ALK genomic tumor aberrations. Nivolumab, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. Nivolumab, in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lungcancer (NSCLC).
Nivolumab as a single agent is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) after prior therapy in adults. Nivolumab is indicated for the treatment of patients | Dosage Form: concentrate for solution for infusion. Strength: 40 mg/4 mL and 100mg/10mL (10mg/mL) |
with intermediate or poor risk, previously untreated advanced renal cell carcinoma, in combination with ipilimumab. Nivolumab, in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced Renal cell carcinoma (RCC).
Nivolumab as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck after platinum- based therapy.
Nivolumab as a single agent is indicated for the treatment of patients with BRAF V600 wildtype unresectable or metastatic melanoma Nivolumab as a single agent is indicated for the treatment of patients with BRAF V600 mutation positive unresectable or metastatic melanoma. Nivolumab is indicated for the treatment of patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection, in the adjuvant settings.
Nivolumab is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after: -autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or -3 or more lines of systemic therapy that includes autologous HSCT.
Nivolumab is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC. Nivolumab is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: -have disease progression during or following platinum-containing chemotherapy. -have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum containing chemotherapy.
|
Nivolumab as monotherapy is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
Nivolumab, in combination with fluoropyrimidine-and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
Nivolumab is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT). | ||||||
80 | M/s Intas Pharmaceuti cals Ltd. | 17.01.2025 | MF/BIO/25/000006 | Pertuzumab, drug substance and drug product | For the treatment of HER2-positive Metastatic Breast Cancer -Pertuzumab is indicated in combination with trastuzumab and docetaxel for patients with HER2- positive metastatic or locally recurrent unresectable breast cancer, who have not yet received any chemotherapy for their metastatic disease | Dosage Form: Concentrate for Solution for Infusion in vial. Strength: 420 mg/14 mL (30 mg/mL) |
81 | M/s Shilpa Biologicals Private Limited | 17.01.2025 | MF/BIO/25/000005 Note: | Adalimumab |
| Dosage Form: Solution for Injection (Single use prefilled syringe for |
Approval for Additional Indication | severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy.
such therapies. | subcutaneous injection) Strength: 40 mg/0.4 mL | ||||
82 | M/s Levim Lifetech Private Limited | 28.02.2025 | MF/BIO/25/000028 Note: Due to name change MA is re- issued. | Liraglutide Drug Substance (r-DNA origin), Liraglutide 6.0 mg/ml solution for injection | For the treatment of Type II Diabetes Mellitus | Dosage Form: Solution for Injection in 3 ml cartridge (18mg/3mL) Strength: 6.0 mg/mL |
83 | M/s Levim Lifetech Private Limited | 01.04.2025 | MF/BIO/25/000031 Note: Due to name change MA is re- issued. | Streptokinase Bulk Solution (r-DNA) origin (Ready-to-fill), Recombinant Streptokinase for Injection, I.P. 15,00,000 IU | Acute Myocardial Infraction | Dosage Form: Lyophilized powder for solution for Injection Strength: 15,00,000 IU/vial |
84 | M/s Reliance Life Sciences Pvt Ltd | 28.04.2025 | MF/BIO/25/000062 Note: Approval for Additional Indication | Denosumab | For the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity | Dosage Form: Solution for Subcutaneous injection in a single use vial Strength: 120mg /1.7 ml |
85 | M/s Enzene Biosciences Ltd. | 13.06.2025 | MF/BIO/25/000085 | Pertuzumab injection (rDNA origin) 420 mg/14mL (Single dose vial with a concentration of 30mg/mL | HER2-positive Metastatic Breast Cancer | Dosage Form: Solution for infusion (Intravenous) Strength: 30mg/mL |
86 | M/s. Zydus Lifesciences Limited, | 19.06.2025 | MF/BIO/25/000092 | Aflibercept 40 mg/mL (2mg/0.05mL) (r- DNA origin) |
| Dosage Form: Sterile solution for intravitreal injection. Strength: 40 mg/mL |
5. Visual impairment due to Myopic Choroidal Neovascularization (myopic CNV) | ||||||
87 | M/s Regenix Biosciences Limited | 23.06.2025 | MF/BIO/25/000096 | Insulin Glargine Injection IP 100IU/mL (r-DNA Origin) | For the treatment of patients diagnosed with Type 2 Diabetes Mellitus | Dosage Form: Solution for Injection in 10 ml vial, 3 ml cartridge and 3 ml cartridge in disposable pen. Strength: 100IU/mL |
88 | M/s. Zydus Lifesciences Limited | 23.06.2025 | MF/BIO/25/000093 | Rituximab 100 mg/10 mL and 500mg/50mL (10mg/mL) (r-DNA origin) |
Zydus Rituximab in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease- modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies. Zydus Rituximab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
positive diffuse large B-cell lymphoma (DLBCL), | Dosage Form: Single dose vial, Concentrate for solution for intravenous infusion. Strength: 10mg/mL |
Burkitt lymphoma (BL)/Burkitt leukaemia (mature B- cell acute leukaemia) (BAL) or Burkitt-like lymphoma (BLL) | ||||||
89 | M/s. Hetero Biopharma Limited | 03.07.2025 | MF/BIO/25/000099 | Denosumab Formulated Drug Substance (r-DNA origin) 70mg/mL | NA | Strength: 70mg/mL |
90 | M/s Virchow Biotech Private Limited | 04-08-2025 | MF/BIO/25/000114 | Rituximab Injection 500mg/50mL and 100 mg/10mL (r- DNA origin) |
ii. Non–Hodgkin’s Lymphoma (NHL) iii. Chronic Lymphocytic Leukemia (CLL) iv. Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA)
| Dosage Form: Solution for infusion (Intravenous) in 10mL and 50mL vial. Strength: 500mg/50mL and 100 mg/10mL |
91 | M/s Biogenomics Limited | 29.08.2025 | MF/BIO/25/000127 | Biphasic Insulin Aspart Injection I.P. (r-DNA origin), 100 IU/ml in 3ml Cartridge and VD Pen 60 (Mixture of insulin aspart and protamine crystallised insulin aspart)(30:70) | Treatment of Diabetes Mellitus in Adults 30 years and above. | Dosage form: Suspension for injection for s. c. use. Strength: 100 IU/ml in 3ml Cartridge and VD Pen 60 |
92 | M/s Biocon Biologics Limited | 14.11.2025 | MF/BIO/25/000156 |
Benzyl alcohol. (10 mL Bacteriostatic Water for Injection will be supplied along with the product).
| Dosage form: Lyophilized powder for solution for injection. Strength: 150 mg / 440 mg |
for injection 440 mg (r-DNA origin) multiple use vial (combipack) supplied along with Bacteriostatic Water for injection containing 1.1% Benzyl alcohol. (2 x 10 mL Bacteriostatic Water for Injection will be supplied along with the product). |
3. Metastatic Gastric Cancer Trastuzumab indicated in adults, in combination with cisplatin and capecitabine or 5-fluorouracil for the treatment of patients with HER2- overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease. | |||||
93 | M/s Zydus Lifesciences Limited | 28.11.2025 | MF/BIO/25/000160 Note: Approval for additional Strength | Bevacizumab | - | - |
94 | M/s Eris Lifesciences Limited | 16.12.2025 | MF/BIO/25/000164 | Isophane Insulin Injection | For the treatment of diabetes mellitus in patients who requires injectable insulin. | Dosage form: Lyophilized powder for solution for injection. Strength: 150 mg / 440 mg |
95 | M/s Eris Lifesciences Limited | 16.12.2025 | MF/BIO/25/000165 | Insulin Injection IP Soluble Insulin, Neutral (Regular) | For the treatment of diabetes mellitus in patients who requires injectable insulin. | Dosage form: Solution for injection Strength: 100 IU/mL, 3 ml Cartridge |
96 | M/s Eris Lifesciences Limited | 16.12.2025 | MF/BIO/25/000174 | Biphasic Isophane Insulin Injection | For the treatment of diabetes mellitus in patients who requires injectable insulin | Dosage form: Solution for injection Strength: 100 IU/mL, 3 ml Cartridge |
97 | M/s Eris Lifesciences Limited | 16.12.2025 | MF/BIO/25/000179 | Insulin Injection IP Soluble Insulin, Neutral (Regular) | For the treatment of Diabetes Mellitus | Dosage form: Solution for injection Strength: 100 IU/mL 10 mL Vial |
98 | M/s Eris Lifesciences Limited | 16.12.2025 | MF/BIO/25/000177 | Insulin Glargine Injection IP | For the treatment of adults, adolescents and children of 6 years or above with diabetes mellitus, where treatment with insulin is required | Dosage form: Solution for injection Strength: 100 IU/mL (3 ml cartridge, 3 ml vial and 5 ml vial) |
99 | M/s Eris Lifesciences | 16.12.2025 | MF/BIO/25/000175 | 1. Biphasic Isophane Insulin Injection | Treatment of diabetes mellitus | Dosage form: Suspension for Injection |
Limited | 2. Biphasic Isophane Insulin Injection | Strength: (30/70) 40 IU/mL, 10 mL vial / (50/50) 40 IU/mL, 10 mL vial | ||||
100 | M/s Eris Lifesciences Limited | 16.12.2025 | MF/BIO/25/000176 |
| Treatment of diabetes mellitus | Dosage form: Suspension for Injection Strength: (30/70) 100 IU/mL, 10 mL Vial / 50/50) 100 IU/mL, 10 mL Vial |
101 | M/s Eris Lifesciences Limited | 17.12.2025 | MF/BIO/25/000168 |
| For the treatment of adults, adolescents and children of 6 years or above with Diabetes mellitus, where treatment with insulin is required. | Dosage form: Suspension for Injection Strength: 100 IU/mL, 10 mL Vial / 100 IU/mL, prefilled pen with 3 mL cartridge |
102 | M/s Eris Lifesciences Limited | 17.12.2025 | MF/BIO/25/000167 | Insulin Injection IP Soluble Insulin (Neutral) | For the treatment of diabetes mellitus in patients who requires injectable insulin. | Dosage form: Solution for injection Strength: 40 IU/mL, 10 mL Vials |
103 | M/s Eris Lifesciences Limited | 17.12.2025 | MF/BIO/25/000178 | Nimotuzumab Injection (Humanized Anti-EGFR monoclonal antibody) | For the treatment of head and neck cancer | Dosage form: Solution for injection Strength: 50 mg |
104 | M/s Enzene Biosciences Ltd. | 19.12.2025 | MF/BIO/23/000001 Note: Approval for Additional Indication | Cetuximab |
RAS wild-type metastatic colorectal cancer in combination with Irinotecan based chemotherapy in first-line in combination with FOLFOX as a single agent in patients who have failed oxaliplatin and irinotecan-based therapy and who are intolerant to irinotecan. | Dosage Form: Solution for Intravenous Infusion in vial Strength: 100 mg/20 ml |
105 | M/s Eris Lifesciences Limited | 19.12.2025 | MF/BIO/25/000182 | Isophane Insulin Injection | For the treatment of diabetes mellitus in patients who requires injectable insulin. | Dosage form: Suspension for injection Strength: 40 IU/mL (10 m Vial) |
106 | M/s Genesys | 29.12.2025 | MF/BIO/25/000186 | Insulin Glargine | For the Treatment of Type II Diabetes Mellitus in | Dosage form: Solution for |
Biologics Pvt. Ltd. | Injection | Adults only | Injection in 3 ml cartridge Strength: 100 IU/mL | |||
107 | M/s Genesys Biologics Pvt. Ltd. | 29.12.2025 | MF/BIO/25/000187 | Insulin Glargine I.P (r-DNA Origin) Drug Substance | - | - |
To view the official list, click the link below:
Also Read: CDSCO Panel Seeks More Clinical Data from Regenix Drugs on rDNA-Based Insulin Injection
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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