CDSCO Drug Alert: 64 Drug Samples Including Aristo's Monocef 500 Flagged
New Delhi: In its latest drug safety alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO) has flagged 62 medicine batches for failing to qualify for a random drug sample test for November– 2023, while two drug samples have been declared misbranded and spurious.These drug samples which are declared not of standard quality include Meropenem Injection...
New Delhi: In its latest drug safety alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO) has flagged 62 medicine batches for failing to qualify for a random drug sample test for November– 2023, while two drug samples have been declared misbranded and spurious.
These drug samples which are declared not of standard quality include Meropenem Injection IP 0.5 g manufactured by Bharat Parenterals, Artesunate injection IP (Zynate) manufactured by Jackson Laboratories, Montelukast Sodium and Levocetirizine Hydrochloride Tablets I.P. manufactured by Unicure India, Ciprofloxacin tablets I.P. 500 mg manufactured by ANG Lifesciences India, Glimepiride tablets I.P. 1 mg manufactured by Apple Formulations and others.
In addition to the above, popular drugs such as Rifampicin capsules IP (R-Cin 150) manufactured by Lupin and Ceftraixone Injection IP (Monocef 500 mg) manufactured by Aristo Pharmaceuticals are also on the list of samples declared as Not of Standard Quality.
This came after analysis and tests conducted by the CDSCO Drugs Control Department on 1197 samples. Out of these, 1133 samples were found to be of standard quality, while 64 of them were declared as not of standard quality (NSQ), including 2 drugs that were declared misbranded and spurious.
A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of the disintegration test, failure of pH and identification test, failure of clarity test, failure of water content test, failure of specific assay of drug test, and others.
The samples collected were tested in five laboratories RDTL Chandigarh, CDL Kolkata, RDTL Guwahati, CDTL Hyderabad, and CDTL Mumbai.
List of Drugs, Medical Devices, Vaccine, and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of November- 2023.
List of Drugs, Medical Devices, Vaccine, and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of November- 2023. | ||||||||
Total number of samples tested - 1197 | ||||||||
Total number of samples declared as Standard Quality - 1133 | ||||||||
Total number of samples declared as Not of Standard Quality - 62 | ||||||||
Total number of samples declared as Spurious - 01 | ||||||||
Total number of samples declared as Misbranded - 01 | ||||||||
S. No | Name of Drugs/medical device/cosmetics | Batch No. | Date of Manufacture | Date of Expiry | Manufactured By | Reason for failure | Drawn By (From state/CDSCO Zone) | From (Name of Laboratory) |
1 | Cefixime, Azithromycin and Lactic Acid Bacillus Tablets (SEFIX-CZ LB TABLETS) | JUN-23102 | Jun-2023 | May-2025 | Bonsai Pharma, Kishanpura, Baddi-Nalagarh Road, P.O.Gurumajara, Distt. Solan (H.P.) | Disintegration test | Drug Control Department Himachal Pradesh | RDTL, Chandigarh |
2 | Paracetamol Tablets IP 500 mg | PRS-520 | Aug-2022 | Jul-2025 | Healers Lab, Unit II, Plot No. 33, H.P.S.I.D.C., Extn., Baddi, Distt. Solan (H.P.) | Dissolution | CDSCO Baddi | RDTL, Chandigarh |
3 | Ondansetron Injection IP (Ondacip Injection ) | ION-10869 | Jun-2023 | May-2025 | E.G. Pharmaceuticals, Vill. Mandhala, Teh.Baddi, Distt. Solan (H.P.) | Particulate Matter | CDSCO Baddi | RDTL, Chandigarh |
4 | Hydrogen Peroxide Topical Solution IP 6% w/v | HP22-021 | Feb-2022 | Jan-2024 | Pharm Asia Durg, 20-21, Panchal Compound, Survey no : 78/1, PH no: 17, New 45, Gram Lasudia Mori, Indore- 452010 (M.P.) | Identification and Acidity | CDSCO North Zone Ghaziabad | RDTL, Chandigarh |
5 | Albendazole Tablets IP | MS1AO2205 | Oct-2022 | Sep-2025 | MAXTAR BIO- GENICS, Khasra No. 705, Vill. Malku Majra, Nalagarh Road, Baddi, Distt. Solan-173205 (H.P.)-India | Dissolution test | Drug Control Department Himachal Pradesh | RDTL, Chandigarh |
6 | Propylene Glycol USP (PGUSP) | F10121UP | Nov-2022 | Nov-2024 | S.K. Picglobal Co.Ltd., 255, Youngjam-ro, Nam-gu, Ulsan, South Korea 680130. | Water Determination | CDSCO North Zone Ghaziabad | CDL, Kolkata |
7 | Methylcobalamin Injection 1 ml | MC-2307 | Aug-2023 | Jan-2025 | Konis Pharmaceuticals, Krishna Nagar - 522 502 (A.P.). | Particulate Matter & Description | CDSCO, Sub- Zone Visakhapatnam | CDL, Kolkata |
8 | Ceftriaxone For Injection USP (SHANU- CEFT 2 GM) | YSF3103 | Aug-2023 | Jul-2026 | Yeluri Formulations Pvt Ltd., Sy. No. 296/7/6, IDA Bollaram, Medak District-502325, Telangana, India. | Constituted Solution & Particulate Matter | CDSCO, Hyderabad | CDL, Kolkata |
9 | DOXORUBICIN HYDROCHLORIDE FOR INJECTION BP 10 MG (DOXOTERO - 10) | OL23085 | Jun-2023 | May-2025 | Biozenta Lifesciences Pvt. Ltd., Khasra No. 59, 60 & 61, Bela Bathri, Haroli, Una, Himachal Pradesh - 174301 | Related Substances & water | CDSCO Hyderabad | CDL, Kolkata |
10 | Palonosetron Injection 0.25 mg / 5 ml (Palonolive) | PSI230501 | May-2023 | Apr-2025 | Bless Pharma India Private Limited, H. No. 3- 90/1/1, D. Pochampally Village, Dundigal, Gandimaisamma Mandal, Medchal- Malkajgiri Dist, Telangana- 500043 | Bacterial endotoxins | CDSCO Hyderabad | CDL, Kolkata |
11 | Granisetron Hydrochloride Injection 3mg / 3ml (EMYTRON) | GSI230101 | Jan-2023 | Dec-2024 | Bless Pharma India Private Limited, H. No. 3- 90/1/1, D. Pochampally Village, Dundigal, Gandimaisamma Mandal, Medchal- Malkajgiri Dist, Telangana- 500043 | Test for ‘pH' | CDSCO, Hyderabad | CDL, Kolkata |
12 | Ceftraixone Injection IP (Monocef 500 mg) | MPD231319 | Apr-2023 | Sep-2025 | Aristo Pharmaceuticals Pvt. Ltd., Plot No. 208, New Industrial Area No. 2, Mandideep - 462046, Dist. Raisen (M.P.) | Clarity of solution | CDSCO, Hyderabad | CDL, Kolkata |
13 | Compound Benzoic Acid Ointment IP - 15g (Whitfield's Ointment) | B21027 | Dec-2021 | Nov-2023 | Vivek Pharmachem (India) Ltd., EPIP, Bari Brahmana, Jammu - 181133. | Assay of Benzoic Acid | CDSCO South Zone Chennai | CDL, Kolkata |
14 | Ceftriaxone Injection IP 1g | CFI23016 | Feb-23 | Jan-25 | Vivek Pharmachem (India) Ltd., NH-8, Chimanpura, Amer, Jaipur - 303 102. | Clarity of solution | CDSCO South Zone Chennai | CDL, Kolkata |
15 | Rabeprazole Sodium (Enteric Coated) & Domperidone (Sustained Release) Capsules (Rabetal- DSR) | RPC-230704 | Jul-2023 | Jun-2025 | Talwar Pharma, Jhabrera Road, Kurdi, Manglour 247656, Roorkee, Distt- Haridwar, Uttarakhand. | Dissolution | CDSCO, Sub-Zone Rishikesh | CDL, Kolkata |
16 | Aceclofenac, Paracetamol & Serratiopeptidase Tablets (ACLOWIN- PLUS) | T-231023 | Oct-2023 | Sep-2025 | Vilin Bio Med Ltd., Unit-II, Khasra No. 85, Madhopur, Hazarathpur, Roorkee - 247667, Uttarakhand. | Description & Assay of Serratiopeptidase | CDSCO Sub-Zone Rishikesh | CDL, Kolkata |
17 | Gabapentin & Amitriptyline HCl Tablets (GABAMER AT) | T-230420 | Apr-2023 | Mar-2025 | Vilin Bio Med Ltd., Unit-II, Khasra No. 85, Madhopur, Hazarathpur, Roorkee - 247667, Uttarakhand. | Assay of Amitriptyline Hydrochloride | CDSCO Sub- Zone Rishikesh | CDL, Kolkata |
18 | Ferrous Ascorbate & L- Methylfolate Tablets (Bravofer) | T-230861 | 08/2023 | 07/2025 | Vilin Bio Med Ltd., Unit-II, Khasra No. 85, Madhopur, Hazarathpur, Roorkee - 247667, Uttarakhand. | Description, Disintegration & Assay of L- Methylfolate | CDSCO, Sub-Zone Rishikesh | CDL, Kolkata |
19 | Propylene Glycol IP | PG-IP/2023- 24/2233 | 08/2023 | 07/2028 | Manali Petrochemicals Limited, Plant-II, Sathangadu Village, Manali, Chennai - 600068 | Water | CDSCO, Sub-Zone Rishikesh | CDL, Kolkata |
20 | CHLORPHENAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE & DEXTROMETHORPHAN HYDROBROMIDE SYRUP (KASJEL-CP SYRUP) | DLS-2540 | 07/2023 | 06/2025 | Daffohils Laboratories Pvt. Ltd., F-109-110, UPSIDC, Industrial Area, Selaqui, Dehradun, U.K.- 248011 (India) | Assay/Content of Chlorphenamine Maleate | CDSCO, Sub-Zone Rishikesh | CDL, Kolkata |
21 | PROPYLENE GLYCOL IP | PG-IP/2022- 23/2512 | 03/2023 | 02/2028 | Manali Petrochemicals Limited, Plant-II, Sathangadu Village, Manali, Chennai - 600068 | Water content | CDSCO, Sub-Zone Rishikesh | CDL, Kolkata |
22 | Propylene Glycol IP | PG-IP/2023- 24/2206 | 08/2023 | 07/2028 | Manali Petrochemicals Limited, Plant-II, Sathangadu Village, Manali, Chennai - 600068 | Water content | CDSCO, Sub-Zone Rishikesh | CDL, Kolkata |
23 | GLICLAZIDE TABLETS IP 40 mg | CHT-3850 | 08/2023 | 07/2025 | Cotec Healthcare Pvt. Ltd., NH No. 74, Roorkee Dehradun Highway, Kishanpur, Roorkee-247667 Uttarakhand. | Assay & Related substances of Gliciazide | CDSCO, Sub-Zone Rishikesh | CDL, Kolkata |
24 | Sorbitol Solution IP (70%) | GAIL-IP-505 | Jun-2023 | Jun-2028 | Goya Agro Industries Pvt. Ltd. | Test for ‘Water’ | CDSCO, Sub-Zone Rishikesh | CDL, Kolkata |
25 | Propylene Glycol IP | PG-IP/2023- 24/2158 | Jul-2023 | Jun-2028 | Manali Petrochemicals Limited. | Water content | CDSCO Sub-Zone Rishikesh | CDL, Kolkata |
26 | Unlabeled white tablets Calcium and Vitamin D3 | Unlabeled | Not mentioned | Not mentioned | Kanha Biogenetic, Plot No. 1B, EPIP, Phase 1, Jharmajri, Baddi, Dist. Solan, (H.P.). | Description | CDSCO Baddi | CDL, Kolkata |
27 | DOBUTAMINE INJECTABLE USP 12.5mg / ml | ALY038 | Jun-2022 | May-2024 | Maya Biotech Pvt. Ltd., Khasra No. 515/3, Village Kondi, P.O. Thana, Baddi (H.P.) | Description, Particulate Matter in injection, Container content and Assay of Dobutamine Hydrochloride | CDSCO Baddi | CDL, Kolkata |
28 | Unlabeled vials with Red seal purported to contains Pantoprazole 40 mg | Unlabeled | Not mentioned | Not mentioned | Affy Parenterals, at Village Gullarwala, Sai Road, Baddi, Distt. Solan (H.P.) | Misbranded with respect to label | CDSCO Baddi | CDL, Kolkata |
29 | Unlabeled unpacked soft gelatin capsules purported to contain Calcitriol 0.25 mcg, Calcium 200 mg, Zinc 7.5mg | Unlabeled | Not mentioned | Not mentioned | Affy Parenterals, at Village Gullarwala, Sai Road, Baddi, Distt. Solan (H.P.) | Assay of Calcitriol, Calcium Carbonate and Zinc Sulphate Monohydrate | CDSCO Baddi | CDL, Kolkata |
30 | ARTESUNATE INJECTION IP (ZYNATE) | I-1219 | Jul-2023 | Jun-2025 | Jackson Laboratories Pvt. Ltd., 22-23, Majitha Road, Bye Pass, Amritsar- 143001 (India) | Bacterial Endotoxin Test, Particulate Matter & Clarity of solution | CDSCO Baddi | CDL, Kolkata |
31 | Methotrexate Injection IP 25 mg / ml (MEREX 1000) | NN3188A | Apr-2023 | Mar-2025 | Naprod Life Sciences Pvt. Ltd., Plot No. G- 17/1, M.I.D.C. Tarapur, Boisar, Dist. Thane - 401506 | Sterility & Bacterial Endotoxin Test | CDSCO Baddi | CDL, Kolkata |
32 | Prebiotic & Probiotic Capsules (Floroquik) | MC230548 | Jul-2023 | Dec-2024 | Mascot Health Series Private Limited, Plot No. 79, 80, Sec-6A, IIE, SIDCUL, Haridwar- 249403 | Assay of total gram positive rod shaped bacterium proposed to be total lactobacillus species | CDSCO East Zone Kolkata | CDL, Kolkata |
33 | Montelukast Sodium and Levocetirizine Hydrochloride Tablets I.P. | MLCT1026 | Feb-2023 | Jan-2025 | Unicure India Ltd., C-21, 22 & 23, Sector-3, Noida- 201301, Distt. Gautam Budh Nagar (U.P.). | Dissolution | CDSCO East Zone Kolkata | CDL, Kolkata |
34 | SPIRONOLACTONE TABLETS IP (SPIRNORAV-100) | SPT221635 | Jul-2022 | Jun-2024 | Salus Pharmaceuticals, 480/211, Harraiur, P.O. Gurumajra, Teh. Baddi, Dist. Solan, (H.P.) - 173205 | Dissolution | CDSCO East Zone Kolkata | CDL, Kolkata |
35 | Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium Citrate & Menthol Syrup | ML220730 | Dec-2022 | Nov-2024 | Mascot Health Series Private Limited, Plot No. 79, 80, Sec-6A, IIE, SIDCUL, Haridwar- 249403 | Assay/content of Menthol | CDSCO East Zone Kolkata | CDL, Kolkata |
36 | RIFAMPICIN CAPSULES IP (R-Cin 150) | A306177 | Jan-2023 | Dec-2024 | Lupin Ltd., A- 28/1, MIDC, Chikalthana, Aurangabad 431210 India. | Dissolution | CDSCO East Zone Kolkata | CDL, Kolkata |
37 | Benzoyl Peroxide 2.5% w/w Gel (Perolite) | M032 | Aug-2022 | Jul-2024 | Elegant Cosmed Pvt. Ltd., Plot No. 32 & 33, GIDC, Kuvadava- 360023, Gujarat. | Assay | CDSCO East Zone Kolkata | CDL, Kolkata |
38 | Fenofibrate Capsules IP 200 mg (LIPICARD) | 28022587 | Nov-2021 | Oct-2023 | USV Private Limited, Plot No.6 & 7E, HPSIDC Indl. Area, Baddi, Dist. Solan, Himachal Pradesh 173205. | Dissolution | CDSCO East Zone Kolkata | CDL, Kolkata |
39 | Paracetamol & Tramadol Hydrochloride Tablets (PAAR-TM) | G012221 | Aug-2022 | Jul-2025 | Baroque Pharmaceuticals Pvt. Ltd., Sokhada- | Uniformity of Dispersion & Assay of Tramadol Hydrochloride | CDSCO, Ahmedabad | CDL, Kolkata |
388620, Ta. - Khambhat, Dist. Anand, Gujarat, India. | ||||||||
40 | DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE & CHLORPHENIRAMINE MALEATE SYRUP | G013207 | Jul-2023 | Jun-2025 | Baroque Pharmaceuticals Pvt. Ltd., Sokhada- 388620, Ta. - Khambhat, Dist. Anand, Gujarat, India. | Assay of Phenylephrine Hydrochloride | CDSCO, Ahmedabad | CDL, Kolkata |
41 | Sodium Chloride Injection IP (0.9% w/v) | K4020007 | Aug-2023 | Jul-2026 | KamlaAmrut Pharmaceutical LLP, Survey No.: 53, 56, 57 At.: Village: Indrad, Near KamlAmrut Industrial Park, Dist.: Mehsana, Gujarat | Assay of Sodium Chloride | CDSCO, Ahmedabad | CDL, Kolkata |
42 | Meropenem Injection IP 0.5 g | PI3075 | Apr-2023 | Mar-2025 | Bharat Parenterals Ltd., Jarod-Samlaya Road, Tal. Savli, Vill.: Haripura, Dist. Vadodara- 391520, Gujarat, India | Bacterial Endotoxin Test | CDSCO, Ahmedabad | CDL, Kolkata |
43 | Methotrexate Injection IP 25 mg / ml (MEREX 1000) | NN3139A | Mar-2023 | Feb-2025 | Naprod Life Science Pvt. Ltd., Plot No. G-17/1, M.I.D.C., Tarapur, Boisar, Dist. Thane- 401506 | Sterility & Bacterial endotoxins | CDSCO, Sub-Zone, Varanasi | CDL, Kolkata |
44 | Methotrexate Injection IP 25 mg / ml (MEREX 1000) | NN3188A | Apr-2023 | Mar-2025 | Naprod Life Science Pvt. Ltd., Plot No. G-17/1, M.I.D.C., Tarapur, Boisar, Dist. Thane- 401506 | Sterility | CDSCO, Sub-Zone, Varanasi | CDL, Kolkata |
45 | AMLODIPINE TABLETS IP 5 mg | NHD22477A | Nov-2022 | Oct-2024 | Nest Healthcare Private Limited., Plot No.300. G.I.D.C., Odhav, Ahmedabad - 382415 (Guj.). India | Related Substances | CDSCO South Zone Chennai | CDTL, Hyderabad. |
46 | BISACODYL GASTRO- RESISTANT TABLETS IP 5 mg | T-230766 | Sep-2023 | Aug-2025 | Sunlife Sciences, 130, Kurdi, Jhabrera Road, Manglour, Roorkee, Distt. Haridwar (U.K.) Pin Code : - 247656 | Dissolution | CDSCO, Indore | CDTL, Hyderabad. |
47 | NIMESULIDE & PARACETAMOL TABLETS (CABLIDE-P) | ST-908A | Jan-2023 | Dec-2024 | Senate Laboratories, 251, 252, Sisona, Roorkee - 247661 (U.K.) | Disintegration | CDSCO Sub Zone, Rishikesh | CDTL, Hyderabad. |
48 | LEVOFLOXACIN TABLETS IP 500 mg | WT-460 | Sep-2023 | Aug-2025 | Wilcure Remedies PRIVATE LIMITED, PH NO.10, Gram Mirzapur, Khandwa Road, Dist. Indore 452020 (MP) India. | Description | CDSCO, Indore | CDTL, Hyderabad. |
49 | METRONIDAZOLE TABLETS IP 200 g | WT-341 | Jul-2023 | Jun-2025 | Wilcure Remedies PRIVATE LIMITED, PH NO.10, Gram Mirzapur, Khandwa Road, Dist. Indore 452020 (MP) India. | Dissolution | CDSCO, Indore | CDTL, Hyderabad. |
50 | Dexamethasone Tablets IP 0.5 mg. (DEXAJOX) | T-22280 | Feb-2023 | Jan-2025 | Kshipra Drugs Pvt. Ltd., 40- 41/22-B, Industrial Area, No. 1, Dewas (M.P.)- 455001 | Description & Assay | Drug Control Department Assam | RDTL, Guwahati |
51 | Paracetamol Tablets I.P. (Paraband-500) | PDN22024 | Jun-2022 | May-2024 | Danish Health Care (P) Ltd., 76/27-28, Industrial Estate, Maxi Road, Ujjain-456 010, INDIA | Dissolution | Drug Control Department Mizoram | RDTL, Guwahati |
52 | PARACETAMOL AND DICLOFENAC SODIUM TABLETS I.P. (DICLOCIN FORTE TABLETS) | NLT-108422 | Mar-2023 | Feb-2025 | Nutra Life Healthcare Pvt. Ltd., Plot No. 44- 45, Shiv Ganga Industrial Estate, Lakeshwari, Bhagwanpur, Roorkee, Distt. Haridwar, Uttarakhand | Dissolution of Paracetamol & Diclofenac Sodium | CDSCO sub zone, Guwahati | RDTL, Guwahati |
53 | Doxylamine Succinate, Pyridoxine Hydrochloride and Folic Acid Tablets. (Doxinate Forte) | DOFM2202 | Feb-2022 | Jan-2025 | Maneesh Pharmaceuticals Ltd., Village Balyana, Barotiwala, Tehsil Kasauli, Dist. Solan (H.P.) 174103. | Disintegration | Drug Control Department, Jharkhand | RDTL, Guwahati |
54 | Telmisartan Tablets I.P. 40 mg. (Telmisev- 40) | CHT22352 | Dec-2022 | Nov-2024 | Cureza Healthcare Pvt. Ltd., A.B. Road, Girwai-474001 | Dissolution | Drug Control Department Nagaland | RDTL, Guwahati |
55 | CIPROFLOXACIN TABLETS I.P. 500 mg. | T032023 | Nov-2022 | Oct-2024 | ANG Lifesciences India Ltd., Village Malkumajra, Nalagarh Road, Baddi, Distt. Solan-173205 (H.P.), INDIA | Dissolution | Drug Control Department Assam | RDTL, Guwahati |
56 | GLIMEPIRIDE TABLETS I.P. 1 mg. | GLT-2301 | Jan-2023 | Dec-2024 | Apple Formulations Pvt. Ltd., Plot No.208, Kishanpur, Roorkee-247667 (U.K) | Dissolution | Drug Control Department Assam | RDTL, Guwahati |
57 | PYRAZINAMIDE TABLETS I.P. 500 mg (PYRIZ-500) | 10734 | Mar-2023 | Aug-2025 | HEALTHY LIFE PHARMA PVT. LTD., FACTORY : N31/1, M.I.D.C., TARAPUR, BOISAR, DIST. PALGHAR- 401 506 INDIA. | Dissolution | Drug Control Department Jharkhand | RDTL, Guwahati |
58 | Ciprofloxacin Tablets I.P. 500 mg | T032022 | Nov-2022 | Oct-2024 | ANG Lifesciences India Ltd.., Village Malkumajra, Nalagarh Road, Baddi, Distt Solan-173205 (H.P.) | Dissolution | Drug Control Department Assam | RDTL, Guwahati |
59 | FRUSEMIDE INJECTION IP 10MG/ML. (FRUSEMIDE) | FEI2208 | Sep-2022 | Aug-2024 | MODERN LABORATORIES, 45- 47, Sector D- 2, Sanwer Road, Indore (M.P.) 452 015 INDIA | Sterility & Bacterial Endotoxins | Drug Control Department Meghalaya | RDTL, Guwahati |
60 | Nextoux Antiroux Expectorant | SN3219 | May-2023 | Apr-2026 | Sangeeta Pharma., A-35, M.I.D.C., Malegaon, Sinnar- 422103, Dist. Nashik | Assay of Dextromethorphan Hydrobromide | CDSCO, West- Zone Mumbai | CDTL - Mumbai |
61 | Paracetamol Tablets 650 mg (Afebril - 650) | 3001 | Mar-2023 | Feb-2025 | Astamed Healthcare (I) Pvt. Ltd., Plot No. 2 & 3, Phase II Genesis Industrial Complex, Kolgaon, Palghar. | Dissolution | CDSCO West Zone Mumbai | CDTL - Mumbai |
62 | Aminophyline Anhydrous BP | AP/23/0008 | Jul-2023 | May-2028 | Bakul Aromatics and Chemicals Pvt. Ltd., Plot No.A/6, MIDC Patalganga, Kaire 410 220 | Water | CDSCO West Zone Mumbai | CDTL - Mumbai |
63 | Aminophyline Anhydrous BP | AP/23/0009 | Jul-2023 | May-2028 | Bakul Aromatics and Chemicals Pvt. Ltd., Plot No.A/6, MIDC Patalganga, Kaire 410 220 | Water | CDSCO West Zone Mumbai | CDTL - Mumbai |
64 | Caffeine Anhydrous BP | CF/23/0007 | Jul-2023 | Jun-2028 | Bakul Aromatics and Chemicals Pvt. Ltd., Plot No.A/6, MIDC Patalganga, Kaire 410 220 | Spurious with respect to the Identification test for caffeine | CDSCO West Zone Mumbai | CDTL - Mumbai |
Also Read:CDSCO Drug Alert: 61 Drug Samples Including Emcure's Levocarnitine Inj Flagged
To view the official notice, click the link below:
Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement/treatment or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2024 Minerva Medical Treatment Pvt Ltd