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Date: 2023-03-30 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of February 2023

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

Gazette Overview

  • 59 samples were declared as Not of Standard Quality.
  • No samples were declared as Spurious or Misbranded.
  • This gazette notification lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for February 2023.
  • A total of 1251 samples were tested during the month.
  • Out of the tested samples, 1192 were declared to be of Standard Quality.

Key Changes

  • 59 drugs/medical devices/cosmetics have been identified as Not of Standard Quality.
  • The notification provides details including the name of the product, batch number, manufacturing and expiry dates, the reason for failure, the authority that drew the sample, and the manufacturing location for each of the 59 items.
  • Reasons for failure include Dissolution issues, pH levels, Assay discrepancies, Identification problems, Bacterial Endotoxins, Sterility issues, Labelling errors, Disintegration issues, Related Substances and Extractable Volume and Particulate Matter.

Impact Analysis

Manufacturers

  • Action Item: Engage with regulatory authorities to understand the specific concerns and demonstrate commitment to compliance.

Distributors and Retailers

  • Action Item: Enhance supplier due diligence to ensure the quality and compliance of purchased products.

Consumers

  • Action Item: Encourage consumers to purchase medicines and medical devices from licensed and reputable sources.

Regulatory Authorities

  • Action Item: Increase public awareness campaigns to educate consumers and healthcare professionals about drug quality and safety.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. RDTL: Regional Drugs Testing Laboratory CDL: Central Drugs Laboratory IP: Indian Pharmacopoeia
Official Source Record View Original Source →
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List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of February – 2023. Total number of samples tested 1251 Total number of samples declared as of Standard Quality 1192 Total number of samples declared as Not of Standard Quality 59 Total number of samples declared as Spurious - Total number of samples declared as Misbranded - S.No Name of Batch No./Date of Reason for failure Drawn By From Drugs/medical Manufacture/Date of device/cosmetics Expiry/Manufactured By 1. OMICERR -20 B. No.: TPC-220263 Dissolution (Acid CDSCO RDTL (Omeprazole Mfg dt: 02/2022 Stage) and Loss on Sub Zone Guwahati Capsules IP) Exp dt: 01/2024 Drying Guwahati Mfd by: M/s Talwar Pharma Jhabrera Road, Kurdi-Manglour-247656, Roorkee Distt.-Haridwar Uttarakhand. 2. Levocetirizine B. No.: DGCR2023 Dissolution Drug RDTL Tablets I.P. Mfg dt: 06/2022 Control Guwahati Levotac Exp dt: 05/2024 Department Mfd by: M/s Cris Jharkhand Pharma (India) Ltd. E- 11, UPSIDC Industrial Area, Selaqui, Dehradun-248011, Uttarakhand. 3. Levocetirizine B. No.: LZR-2202 pH Drug RDTL Dihydrochloride Mfg dt: 01/2022 Control Guwahati Syrup., 30ml Exp dt: 12/2023 Department Mfd by: M/s. Apple Bihar Formulations Pvt. Ltd. Plot No. 208 Kishanpur, Roorkee - 247667 Uttarakhand. 4. Levocetirizine B. No.: LZR-2203 pH Drug RDTL Dihydrochloride Mfg dt: 01/2022 Control Guwahati Syrup Exp dt: 12/2023 Department Mfd by: M/s Apple Bihar Formulations Pvt. Ltd. Plot No. 208 Kishanpur, Roorkee-247667 Uttarakhand. 5. Azithromycin B. No.: BL-12913 Assay Drug RDTL Tablets IP Mfg dt: 12/2021 & Control Guwahati Page 1 of 12(BARLOCIN-250) Exp dt: 11/2023 Dissolution Department Mfd by: M/s. Park Jharkhand Pharmaceuticals, 272, Ind. Area, Phase II, Panchkula 134113 Haryana. 6. Roxclave-625 B. No.: SRBT-22280 Identification of Drug RDTL Tablets Mfg dt: 06/2022 Potassium Control Guwahati (Amoxycillin & Exp dt: 11/2023 Clavulanate, Assay Department Potassium Mfd by: M/s. SPAS of Amoxycillin as Jharkhand Clavulanate Tablets REMEDISE, Vill-Bersan, well as Dissolution I.P.) P.O. Lodhi Majra, Tehsil-Baddi, Distt. Solan, Himachal Pradesh -173205. 7. Pantoprazole B. No.: 21443328 Identification Drug RDTL Gastro- resistant Mfg dt: 11/2021 & Control Guwahati Tablets IP Assay of Exp dt: 04/2024 Department PAN 40 Pantoprazole Mfd by: M/s. ALKEM Assam ALKEM HEALTH SCIENCE A unit of Alkem Laboratories Limited, Unit-2 Samardung, Karek Block, P.O.: Namthang, South Sikkim-737137. 8. Penta-40 B. No.: CT30674 Dissolution Drug RDTL (Pantoprazole Mfg dt: 07/2022 Control Guwahati Sodium Gastro- Exp dt: 06/2024 Department resistant Mfd by: M/s. Cosmas Jharkhand Tablets I. P.) Pharmacls Ltd., Buranwala Road, Village: Kotla, P.O.: Barotiwala, Solan, Himachal Pradesh – 174103. 9. Levocetirizine B. No.: LZR-2204 pH Drug RDTL Dihydrochloride Mfg dt: 01/2022 Control Guwahati Syrup., 30ml Exp dt: 12/2023 Department Mfd by: M/s. Apple Bihar Formulations Pvt. Ltd. Plot No. 208 Kishanpur, Roorkee - 247667- Uttarakhand. Page 2 of 1210. GEMSOLINE B. No.: MDS-22C03 pH Drug RDTL SUSPENSION Mfg dt: 03/2022 Control Guwahati (Calcium Carbonate Exp dt: 02/2024 Department with Vitamin B12 & Mfd by: M/s. Quixotic Mizoram Cholecalciferol Healthcare, 88-A, EPIP, suspension) Phase-II, Thana, Baddi, Distt. Solan, Himachal Pradesh – 173205. 11. Calcium & Vitamin B. No.: OLL22009 Dissolution of Drug RDTL D3 Tablets IP Mfg dt: 07/2022 Calcium Control Guwahati (OSTOSHELL-500) Exp dt: 06/2024 Department Mfd by: M/s. Danish Jharkhand Health Care (P) Ltd., 76/27-28, Industrial Estate, Maxi Road, Ujjain-456010, Madhya Pradesh, INDIA. 12. DIVIRON-SR B. No.: T-2387 Dissolution Drug RDTL (Diclofenac Mfg dt: 12/2021 Control Guwahati Prolonged Release Exp dt: 11/2023 Department Tablets I.P. 100mg) Mfd by: M/s. Jakson Jharkhand Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar- 143001, Punjab (India). 13. Calcium & Vitamin B. No.: G-T554 Dissolution of Drug RDTL D3 Tablets IP Mfg dt: 07/2022 Calcium Control Guwahati (CAL D3M Tablets) Exp dt: 06/2024 Department Mfd by: M/s. Globin Jharkhand Pharmaceuticals Pvt. Ltd., Puhana Chowk, Dehradun Road, Roorkee, Distt. Haridwar, Uttarakhand. 14. Amoxycillin & B. No.: CH042014 Assay of Clavulanic Drug RDTL Potassium Mfg dt: 04/2022 Acid and Dissolution Control Guwahati Clavulanate Tablets Exp dt: 03/2024 of Amoxycillin and Department IP Mfd by: M/s. Park Clavulanic Acid Jharkhand CLAVPARK 625 Pharmaceuticals, Vill. Kalujhanda, Near Nanakpur, Teh. Baddi, Dist. Solan, Himachal Pradesh - 174103. 15. Piperacillin & B. No.: UNI-220071 Assay of Drug RDTL Tazobactam for Mfg dt: 08/2022 Piperacillin & Control Guwahati Injection Page 3 of 12Tazotal-P Exp dt: 07/2024 Tazobactam Department Mfd by: M/s. Unital Bihar Formulation,114-B, EPIP, Phase-1, Jharmajri, Baddi, Solan, Himachal Pradesh. 16. CIPROFLOXACIN B. No.: 0701122 Dissolution Drug RDTL HYDROCHLORIDE Mfg dt: 05/2022 Control Guwahati TABLETS I.P. Exp dt: 04/2025 Department 500MG Mfd by: Jharkhand M/s.KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LIMITED, Plot No. 14, II Phase, Peenya, Bengaluru.-.560058. 17. NS (Sodium B. No.: S1FBV69 Bacterial Drug CDL Chloride Injection IP Mfg dt: 01/2022 endotoxins Control Kolkata (0.9% w/v) – 500 ml Exp dt: 12/2023 Department Mfd by: M/s. Swaroop Odisha Pharmaceuticals Pvt. Ltd. A-10, Tala Nagari Industrial Area, Aligarh - 202001, Uttar Pradesh. 18. RL 500 ml, B. No.: S2FBV20 Bacterial Drug CDL Compound Sodium Mfg dt: 02/2022 endotoxins Control Kolkata Lactate Injection IP Exp dt: 01/2024 Department (Ringer Lactate Mfd by: M/s. Swaroop Odisha Solution for Inj.) Pharmaceuticals Pvt. Ltd. A-10, Tala Nagari Industrial Area, Aligarh - 202001, Uttar Pradesh. 19. RL 500 ml, B. No.: S2FBV22 Bacterial Drug CDL Compound Sodium Mfg dt: 02/2022 endotoxins Control Kolkata Lactate Injection IP Exp dt: 01/2024 Department (Ringer Lactate Mfd by: M/s. Swaroop Odisha Solution for Inj.) Pharmaceuticals Pvt. Ltd. A-10, Tala Nagari Industrial Area, Aligarh - 202001, Uttar Pradesh. 20. RL 500 ml, B. No.: S2FBV21 Bacterial Endotoxins Drug CDL Compound Sodium Mfg dt: 02/2022 & Control Kolkata Lactate Injection IP Exp dt: 01/2024 Sterility Department (Ringer Lactate Mfd by: M/s. Swaroop Odisha Solution for Inj.) Pharmaceuticals Pvt. Ltd. A-10, Tala Nagari Page 4 of 12Industrial Area, Aligarh - 202001, Uttar Pradesh. 21. RL 500 ml, B. No.: S2FBV42 Bacterial endotoxins Drug CDL . Compound Sodium Mfg dt: 02/2022 Control Kolkata Lactate Injection IP Exp dt: 01/2024 Department (Ringer Lactate Mfd by: M/s. Swaroop Odisha Solution for Inj.) Pharmaceuticals Pvt. Ltd. A-10, Tala Nagari Industrial Area, Aligarh - 202001, Uttar Pradesh. 22. Ofsin-D (Ofloxacin B. No.: OFD.275 Assay of Ofloxacin Drug CDL Suspension), Mfg dt: 09/2022 Control Kolkata 60 ml Exp dt: 08/2024 Department Mfd by: M/s. Onus Life Andhra Sciences, Survey No. Pradesh 277/14, Saripally Road, Nellimarla -535217, Vizianagaram, Andhra Pradesh. 23. Propylene Glycol IP B. No.: PG-IP/2022- Test for Water Drug CDL 100 ml 23/2027 Control Kolkata Mfg dt: 04/2022 Department Exp dt: 03/2027 Andhra Mfd by: M/s. Manali Pradesh Petro Chemicals Pvt. Ltd., Plant II, Sathangadu Village, Manali, Chennai – 600 068, India. 24. COOL PLUS Syrup B. No.: OCP.260 Assay of Drug CDL (Paracetamol, Mfg dt: 04/2022 Phenylephrine Control Kolkata Phenylephrine Hcl, Exp dt: 03/2024 Hydrochloride & Department Chloropheniramine Mfd by: M/s. Onus Life Sodium Citrate Andhra Maleate, Sodium Sciences, Survey No. Pradesh Citrate & Menthol 277/14, Saripally Road, Syrup), 60 ml Nellimarla -535217, Vizianagaram, Andhra Pradesh. 25. BENOLIPE B. No.: B2207306B Assay of Alpha CDSCO, CDL (Methylcobalamin, Mfg dt: 07/2022 Lipoic Acid South Zone Kolkata Alpha Lipoic Acid, Exp dt: 12/2023 Chennai Inositol, Folic Acid, Mfd by: M/s. Bymaa Chromium Laboratories Pvt. Ltd., Picolinate, Selenium A-19, 20, 21 & 22 Page 5 of 12Dioxide, and Electronic Park, PIPDIC Benfotiamine, Industrial Estate, Capsules) Thirubhuvanai, Puducherry 605 107. 26. HITOP 5 ml Eye B. No.: 2201 Assay CDSCO CDL Drops Mfg dt: 06/2022 South Zone Kolkata (Proparacaine Exp dt: 05/2023 Chennai Hydrochloride Mfd by: M/s. Suyassh Opthalmic Solution Pharmaceuticals, 216/5- USP 0.5% w/v) 6, Village: Khundh, Taluka: Chikhil, Dist. Navsari, Gujarat. 27. Hepacel 25000 B. No.: ATFT2002 Assay CDSCO CDL IU/5 ml (Heparin Mfg dt: 08/2022 Hyderabad Kolkata Sodium Injection Exp dt: 07/2024 I.P.) Mfd by: M/s. Aishwarya Healthcare, Vill. Thana, Baddi Dist. Solan, Himachal Pradesh, India -173205. 28. Taze (Piperacillin B. No.: 322-350 Assay of CDSCO CDL and Tazobactam Mfg dt: 05/2022 Tazobactum East Zone Kolkata Injection I.P.) Exp dt: 04/2024 Kolkata Mfd by: M/s. Zee Laboratoeis, 47, Industrial Area, Paonta Sahib- 173 025, Himachal Pradesh. 29. Rosuvastatin, B. No.: UGC22071 Description, Assay CDSCO CDL Aspirin and Mfg dt: 03/2022 & Dissolution of East Zone Kolkata Clopidogrel Exp dt: 02/2024 Rosuvastatin Kolkata Capsules Mfd by: M/s. Unimarck Healthcare Ltd., Plot No. 24, 25 & 37, Sector - 6A, SIDCUL, Haridwar 249403, Uttarakhand. 30. PARACIN - SR B. No.: ZTN2I04 Dissolution & Assay CDSCO CDL (Paracetamol Mfg dt: 09/2022 East Zone Kolkata Sustained Release Exp dt: 08/2024 Kolkata Tablets 1000 mg) Mfd by: M/s. Zaneka Healthcare Ltd., BHEL, Ancillary Estate, Ranipur, Haridwar – 249 403, Uttarakhand. Page 6 of 1231. Rabomas - DSR B. No.: MC22800 Assay & Dissolution CDSCO CDL (Rabeprazole Mfg dt: 08/2022 of Rabeprazole East Zone Kolkata Sodium & Exp dt: 07/2024 Sodium Kolkata Domperidone (SR) Mfd by: M/s. Mascot Capsules) Health Series Pvt. Ltd., Plot No. 79, 80, Sec - 6A, IIE, Sidcul, Haridwar – 249 403, Uttarakhand. 32. Cildapin 10 Tablets B. No.: MT223472B Dissolution CDSCO CDL (Cilnidipine Tablets Mfg dt: 07/2022 East Zone Kolkata IP) Exp dt: 06/2024 Kolkata Mfd by: M/s. Mascot Health Series Pvt. Ltd., Plot No. 79, 80, Sec 6A, IIE, Sidcul, Haridwar – 249 403, Uttarakhand.. 33. CLAVAM 625 B. No.: 22442326 Identification and CDSCO CDL (Amoxycillin and Mfg dt: 08/2022 Assay East Zone Kolkata Potassium Exp dt: 01/2024 Kolkata Clavulanate Tablets Mfd by: M/s. Alkem IP) Health Science, A unit of Alkem Laboratories Ltd., Unit - 2, Samardung, Karek Block, P.O. Namthang, South Sikkim -737137. 34. Montek LC B. No.: SIC3283A Identification & CDSCO CDL (Montelukast Mfg dt: 12/2021 Assay of East Zone Kolkata Sodium and Exp dt: 05/2024 Montelukast Sodium Kolkata Levocetirizine Mfd by: M/s. Sun & Assay of Hydrochloride Pharma Laboratories Levocetirizine Tablets IP) Ltd., Plot No. 107-108, Hydrochloride Namli Block, P.O. Ranipool, East Sikkim 737 135. 35. AUGMENTIN 625 B. No.: MK 203 Identification and CDSCO CDL DUO (Amoxycillin Mfg dt: 04/2022 Assay East Zone Kolkata and Potassium Exp dt: 09/2023 Kolkata Clavulanate Tablets Mfd by: M/s. Medreich IP) Limited, 12th Mile Stone, Old Madras Road, Virgonagar, Bengaluru 560 049. Page 7 of 1236. Cyra-D B. No.: CD-11449 Dissolution of CDSCO CDL (Rabeprazole Mfg dt: 10/2021 Domperidone & East Zone Kolkata Sodium & Exp dt: 09/2023 Assay of Kolkata Domperidone Mfd by: M/s. Mapro Rabeprazole Capsules) Pharmaceuticals Pvt. Sodium & Ltd., (Unit -2), Q Road, Domperidone Phase IV, G.I.D.C. Wadhwan 363035, Surendranagar, Gujarat. 37. Pan 40 B. No.: 22442631 Dissolution CDSCO CDL (Pantoprazole Mfg dt: 09/2022 East Zone Kolkata Gastro-resistant Exp dt: 02/2025 Kolkata Tables IP) Mfd by: M/s. Alkem Health Science, A unit of Alkem Laboratories Limited, Unit -2, Samardung Block, Karek Block, P.O. Namthang, South Sikkim -737 137. 38. Telma 40 B. No.: 18220015 Identification CDSCO CDL (Telmisartan Tablets Mfg dt: 01/2022 & East Zone Kolkata I.P. 40 mg) Exp dt: 12/2024 Assay Kolkata Mfd by: M/s. Glenmark Pharmaceuticals Ltd., Samlik Marchak, Industrial Growth Centre, East Sikkim, Sikkim -737135. 39. Monocef - O B. No.: BPH222546 Identification, Assay CDSCO CDL (Cefpodoxime Mfg dt: 08/2022 & Uniformity of East Zone Kolkata Tablets IP 200 mg) Exp dt: 07/2024 weight Kolkata Mfd by: M/s. Aristo Pharmaceuticals Pvt. Ltd., Village: Makhnumajra, P.O. Bhud, Baddi, Dist. Solan, Himachal Pradesh -173205. 40. Taxim - O 200 B. No.: 22181259 Identification CDSCO CDL (Cefixime Tablets Mfg dt: 08/2022 & East Zone Kolkata I.P.) Exp dt: 07/2024 Assay Kolkata Mfd by: M/s. Alkem Health Science, A Unit Page 8 of 12of Alkem Laboratories Limited, Unit -2, Samardung, Karek Block, P.O. Namthang, South Sikkim - 737 137. 41. Renox-40 B. No.: 21EN22 Identification CDSCO CDL (Enoxaparin Sodium Mfg dt: 06/2021 & East Zone Kolkata Injection I.P. 40 mg / Exp dt: 05/2023 Assay Kolkata 0.4ml) Mfd by: M/s. Sai Parenterals Pvt. Ltd., D4, Phase V, IDA, Jeedimetla, Hyderabad – 500 055, Telangana. 42. Ridtas-S B. No.: RT220619 Dissolution CDSCO CDL (S(-) Amlodipine Mfg dt: 08/2022 & East Zone Kolkata Tablets I.P.) Exp dt: 07/2024 Assay of Kolkata Mfd by: M/s. Ridley S (-) Amlodipine Lifesciences Pvt. Ltd., D-1651, DSIDC, Indl. Complex, Narela, Delhi 110 040. 43. Atorvastatin B. No.: SGT-2281 Assay of Aspirin CDSCO CDL And Mfg dt: 04/2022 And East Zone Kolkata Aspirin Tablets Exp dt: 03/2024 Atorvastatin Kolkata Mfd by: M/s. Spectrum Formulations Pvt. Ltd., Khasra No. 12, Makhanpur Bhagwanpur, Roorkee, Haridwar , Uttarakhand – 247 661. 44. Paracetamol B. No.: AP-5205 Extractable Volume CDSCO CDL Injection 150 mg Mfg dt: 05/2022 & East Zone Kolkata Exp dt: 04/2024 Particulate Matter Kolkata Mfd by: M/s. Alchemist Remedies Pvt. Ltd., 138-139, Industrial Area No. 2, A. B. Road, Dewas Madhya Pradesh. 45. Gebcare - 100 B. No.: T221337 Related CDSCO CDL (Gabapentin Tablets Mfg dt: 05/2022 Substances East Zone Kolkata I.P. 100 mg) Exp dt: 04/2024 Kolkata Mfd by: M/s. United Page 9 of 12Bioceuticals Pvt. Ltd., Plot No. 33C, Industrial Park - IV, Begumpur, Haridwar – 249 402, Uttarakhand. 46. Zinc Sulphate B. No.: ZST922 Assay CDSCO CDTL Dispersible Tablets Mfg dt: 02/2022 Subzone Chennai IP 20 mg Exp dt: 01/2024 Bangalore Mfd by: M/s. Unicure India Ltd.,C-21, 22 & 23, Sector -3,Noida- 201301, Distt. Gautam Budh Nagar, Uttar Pradesh. 47. Olben Cream B. No.: 22316 Labelling CDSCO CDTL (Cream for Dry Mfg dt: 04/2022 Subzone Chennai Skin) (On sample (Primary container) Bangalore 04/2024 [On Carton Box] Exp dt: Not stated (On sample (Primary container) 03/2024 [On Carton Box] Mfd by: M/s. Olcare Laboratories, 505/A, G.I.D.C. Estate, Wadhwancity– 363035 Dist. Surendranagar, Gujarat. 48. Ciprofloxacin B. No.: 0600120 Dissolution CDSCO CDTL Hydrochloride Mfg dt: 06/2020 Subzone Chennai Tablets IP 250 mg Exp dt: 05/2023 Bangalore Mfd by: M/s. Karnataka Antibiotics and Pharmaceuticals Ltd., Plot No.14, II Phase, Peenya Industrial Area, Bengaluru – 560058. 49. Amtas PRP B. No.: K2102200 Perindopril CDSCO CDTL (Amlodipine And Mfg dt: 10/2021 Erbumine Assay Sub - Zone Mumbai Perindopril Tablets) Exp dt: 09/2024 Indore. Mfd by: M/s. Intas Pharmaceuticals Ltd., Bhagey Khola, Rangpo, East Sikkim – 737 132. 50. Ramipril Tablets IP B. No.: TPTGOV-21166 Assay and CDSCO CDTL 5 mg Mfg dt: 07/2021 Dissolution West -Zone Mumbai Page 10 of 12Exp dt: 06/2023 Mumbai Mfd by: M/s. Terrace Pharmaceuticals (P) Ltd., 3-B (a) Phase III, Industrial Area, Sansarpur Terrace, Distt. Kangra, Himachal Pradesh - 176501. 51. Glimepiride Tablets B. No.: T22051 Related CDSCO CDTL IP 1 mg Mfg dt: 02/2022 Substances Sub-Zone Mumbai Exp dt: 01/2024 Indore. Mfd by: M/s. Trugen Pharmaceuticals Pvt. Ltd., Vill. Tejjupur, Near Chodiala Rly. Station, Roorkee, Distt- Haridwar, Uttarakhand – 247661. 52. Glimepiride Tablets B. No.: T22060 Related CDSCO CDTL IP 1 mg Mfg dt: 03/2022 Substances Sub-Zone Mumbai Exp dt: 02/2024 Indore Mfd by: M/s. Trugen Pharmaceuticals Pvt. Ltd., Vill. Tejjupur, Near Chodiala Rly. Station, Roorkee, Distt- Haridwar, Uttarakhand – 247661. 53. PHENIRAMINE B. No.: APV-2001 Description, CDSCO CDTL MALEATE Mfg dt: 12/2020 Uniformity of Weight Zonal Office Hyderabad TABLETS IP Exp dt: 11/2023 and Assay Hyderabad (APVIL) Mfd by: M/s. Ridley life science Pvt. Ltd, D- 1651, DSIDC, Indl. Complex, Nerela, Delhi- 110040. 54. DICLOFENAC B. No.: TS7463 Disintegration CDSCO CDTL SODIUM TABLETS Mfg dt: 11/2022 (Acid Stage) Zonal Office Hyderabad I.P. 50 mg Exp dt: 10/2024 Hyderabad Mfd by: M/s. Adroit Pharmaceuticals Pvt. Ltd., At: 46, Garoba Maidan, Nagpur-8, Maharashtra. Page 11 of 1255. AMLODIPINE AND B. No.: MRT1846 Dissolution and CDSCO CDTL ATENOLOL Mfg dt: 12/2021 Assay Zonal Office Hyderabad TABLETS IP Exp dt: 11/2023 Hyderabad (ALAMO-AT) Mfd by: M/s. M.R. Healthcare Pvt. Ltd., Village Tanda Mallu, Kashipur Road, Ramnagar- 244715, Dist. Nainital, Uttarakhand (India). 56. Glimepiride Tablets B. No.: GPU-511 Dissolution CDSCO RDTL IP 1 mg Mfg dt: 09/2021 and North Zone Chandigarh Exp dt: 08/2023 Related Substances Mfd by: M/s. Healers Lab Unit II, Plot No. 33, H.P.S.I.D.C., Extn., Baddi, Distt-Solan, Himachal Pradesh. 57. Ventoxen B. No.: 22VC 1 03A Identification CDSCO RDTL (Venetoclax) Mfg dt: 05/2022 and North Zone Chandigarh Tablets 100 mg Exp dt: 04/2024 Assay of Venetoclax Mfd by: M/s. Everest Pharmaceuticals Ltd., BSCIC I/A, Kanchpur, Narayanganj, Bangladesh. 58. Calcium and B. No.: T179168 Assay of Vitamin D3 CDSCO RDTL Vitamin D3 Mfg dt: 05/2022 North Zone Chandigarh Tablets IP Exp dt: 04/2024 Mfd by: M/s. Quest Laboratories Pvt. Ltd., Plot No. 45, Sector-III, Pithampur, Dist. Dhar- 454775 ,Madhya Pradesh. 59. Albendazole Tablets B. No.: EVT-22080 Dissolution Drug RDTL IP (Altai 200 Mfg dt: 07/2022 Control Chandigarh Tablets) Exp dt: 06/2024 Department Mfd by: M/s. Events Himachal Corporation, UNIT-II, Pradesh Nahan Road, Kala Amb, Distt. Sirmour, Himachal Pradesh- 173030. Page 12 of 12

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