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Date: 2022-12-13 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of November 2022

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

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Executive Summary & Key Takeaways

Gazette Notification

  • This gazette notification lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for November 2022.
  • A total of 1487 samples were tested.
  • 1404 samples were declared to be of Standard Quality.
  • 83 samples were declared as Not of Standard Quality.
  • No samples were declared as Spurious or Misbranded in this notification.

Key Changes

  • 83 drugs, medical devices and cosmetics have been identified as Not of Standard Quality based on various reasons such as failure in Identification, Assay, Dissolution, Disintegration, pH, Uniformity of weight, Description, Clarity, Sterility, Bacterial Endotoxins, Related Substances, Neps, Particulate Matter and Colour of Solution.
  • The products listed are manufactured by various companies located across India, including those in Bihar, Himachal Pradesh, Uttarakhand, Madhya Pradesh, Jharkhand, Assam, Sikkim, Haryana, Gujarat, Rajasthan, Telangana, Odisha, Maharashtra, Punjab, Andhra Pradesh, Uttar Pradesh and West Bengal.
  • The products were tested by Drug Control Departments and CDSCO (Central Drugs Standard Control Organization) through various Zonal and Regional Drug Testing Laboratories (RDTL) and Central Drug Laboratories (CDL).

Impact Analysis

Manufacturers

  • Immediate action: Review manufacturing and testing protocols for listed products. Prepare for potential regulatory audits and enforcement actions.

Distributors and Retailers

  • Immediate action: Quarantine and cease distribution/sale of listed products. Coordinate returns with manufacturers.

Consumers

  • Immediate action: Issue a public advisory regarding the listed products. Encourage consumers to report adverse events.

Government and Regulatory Agencies

  • Immediate action: Increase market surveillance and inspections of manufacturing units. Collaborate with state drug controllers for coordinated action.

Our Organization

  • Immediate action: Cross-check our inventory against the list. Review vendor contracts and quality agreements.

Key Entities Referenced

Drugs, Medical Devices and Cosmetics Act: This act regulates the manufacture, sale, and distribution of drugs, medical devices, and cosmetics in India to ensure their safety, efficacy, and quality. CDSCO (Central Drugs Standard Control Organization): The Central Drugs Standard Control Organization is the national regulatory authority for pharmaceuticals and medical devices in India. It is responsible for approval of new drugs, clinical trials, setting standards for drugs, control over the quality of imported drugs, and coordination of the activities of State Drug Control Organizations. RDTL (Regional Drugs Testing Laboratory): Regional Drugs Testing Laboratories are established by the government to facilitate the testing and analysis of drugs and cosmetics to ensure their quality and compliance with standards. CDL (Central Drug Laboratory): The Central Drugs Laboratory (CDL) Kolkata, is the National statutory apex laboratory of the Government of India for quality control of drugs and pharmaceuticals.
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List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of November – 2022. Total number of samples tested 1487 Total number of samples declared as of Standard Quality 1404 Total number of samples declared as Not of Standard Quality 83 Total number of samples declared as Spurious - Total number of samples declared as Misbranded - S.No Name of Batch No./Date of Reason for Drawn By From Drugs/medical Manufacture/Date of failure device/cosmetics Expiry/Manufacture d By 1. Ibuprofen Oral B. No.: IPS6-21-221 ‘pH’ Drug Control RDTL Suspension B.P., Mfg dt: 02/2022 Department Guwahati 60ml Exp dt: 01/2024 Bihar Mfd by: M/s. ORNATE LABS PVT. LTD., Bela Industrial Estate, Muzaffarpur- 842005, Bihar. 2. Telmisartan Tablets IP B. No.: T101006 Description Drug Control RDTL 40 mg Mfg dt: 09/2021 Department Guwahati Exp dt: 08/2023 Bihar Mfd by: M/s. ANG Lifesciences India Ltd.,Village Malkumajra, Nalagarh Road, Baddi, Distt. Solan- 173205, Himachal Pradesh. 3. Pantop-DSR® B. No.: SPA220030 Identification Drug Control RDTL (Pantoprazole Sodium Mfg dt: 01/2022 and Assay/ Department Guwahati Gastro-resistant & Content of Exp dt: 12/2023 Mizoram Domperidone ‘Pantoprazole Mfd by: M/s. ARISTO Prolonged- release and Pharmaceuticals Capsules IP) Domperidone’ Private Limited, Plot Nos.: 2040-46, N.H. 10, Baghey Khola, P.O. Majhitar, East – Sikkim, 737 136. 4. Norfloxacin and B. No.: STC21450 Identification Drug Control RDTL Tinidazole Tablets Mfg dt: 09/2021 & Department Guwahati (Norflox-TZ RF) Exp dt: 08/2024 Assay Assam Page 1 of 19Mfd by: M/s. Shivalik Remedies Pvt. Ltd., Village - Nanhera Anantpur, Puhana- Iqbalpur road, Roorkee, Dist. Haridwar, (Uttarakhand) 247 667, INDIA 5. B - Complex Capsules B. No.: UGC22022 Description Drug Control RDTL Mfg dt: 01/2022 Department Guwahati Exp dt: 06/2023 Bihar Mfd by: M/s. UNIMARCK HEALTHCARE LTD., Plot No - 24, 25 & 37, Sector 6A, SIDCUL, Haridwar – 249 403, Uttarakhand. 6. B - Complex Capsules B. No.: UGC22048 Description Drug Control RDTL Mfg dt: 02/2022 Department Guwahati Exp dt: 07/2023 Bihar Mfd by: M/s. UNIMARCK HEALTHCARE LTD., Plot No - 24, 25 & 37, Sector 6A, SIDCUL, Haridwar – 249 403, Uttarakhand. 7. Primaquine Phosphate B. No.: PQH-08 Assay Drug Control RDTL Tablets IP Mfg dt: 11/2021 Department Guwahati Exp dt: 10/2024 Jharkhand Mfd by: M/s. Askon Health Care 11-B, Industrial Area, Maxi Road, Ujjain- 456010, Madhya Pradesh. 8. Domperidone B. No.: DPS3-21-221 Assay Drug Control RDTL Suspension IP, 30ml Mfg dt: 01/2022 Department Guwahati Exp dt: 12/2023 Bihar Mfd by: M/s. ORNATE LABS PVT. LTD. Bela Industrial Estate, Muzaffarpur- 842005 Bihar. Page 2 of 199. SHELCAL®-500 B. No.: 8LV2H077 Identification of Drug Control RDTL (Calcium And Vitamin Mfg dt: 06/2021 Vitamin D3, Department Guwahati D 3 Tablets I.P.) Exp dt: 05/2023 Dissolution Assam Mfd by: M/s. Pure (Calcium) and and Cure Healthcare Assay of Pvt. Ltd. Elemental Plot No. 26A-30, Calcium & Sector-8A, IIE Vitamin D3 SIDCUL, Ranipur, Haridwar-249 403, Uttarakhand. 10. PQUIN-2.5 B. No.: CN2102 Dissolution Drug Control RDTL (Primaquine Mfg dt: 09/2021 and Assay Department Guwahati Phosphate Tablets IP Exp dt: 08/2023 Jharkhand 2.5 mg) Mfd by: M/s. CENTURY DRUGS PVT. LTD. Plot No. 38, Sector-3, Pithampur, Dist.- Dhar. Madhya Pradesh. 11. Pantop- D SR® B. No.: SPJ211372 Identification Drug Control RDTL (Pantoprazole Sodium Mfg dt: 09/2021 and Department Guwahati Gastro-resistant & Assay/Content Exp dt: 08/2023 Mizoram Domperidone of Mfd by: M/s. ARISTO Prolonged-release Pantoprazole Pharmaceuticals Capsules IP) & Private Limited Domperidone Plot Nos.: 2040-46, and N.H. 10, Baghey Description Khola, P.O. Majhitar, East-Sikkim, 737 136. 12. DICLORIN PLUS B. No.: DR-152 Uniformity of Drug Control RDTL (Diclofenac Sodium & Mfg dt: 09/2021 weight of Department Guwahati Paracetamol Tablets) Tablet and Exp dt: 08/2024 Bihar Assay of Mfd by: M/s. Paracetamol ANDISONS PHARMIX, Bhagwati Sadan, Mahabir Path, Lohanipur, Patna – 800 003, Bihar. 13. Levocetirizine B. No.: LZR-2202 ‘pH’ Drug Control RDTL Dihydrochloride Syrup. Mfg dt: 01/2022 Department Guwahati 30 ml Exp dt: 12/2023 Bihar Mfd by: M/s. Apple Formulations Pvt. Ltd. Plot No. 208, Kishanpur, Roorkee- Page 3 of 19247667, Uttarakhand. 14. Paracetamol Tablets B. No.: T120214 Dissolution Drug Control RDTL IP 650mg Mfg dt: 04/2022 Department Guwahati Exp dt: 03/2024 Assam Mfd by: M/s. ANG Lifesciences India Ltd., Village Malkumajra, Nalagarh Road, Baddi, Dist. Solan- 173205, Himachal Pradesh. 15. Levocetirizine B. No.: LZR-2207 ‘pH’ Drug Control RDTL Dihydrochloride Syrup Mfg dt: 01/2022 Department Guwahati (30 ml) Exp dt: 12/2023 Bihar Mfd by: M/s. Apple Formulations Pvt. Ltd. Plot No. 208, Kishanpur, Roorkee- 247667, Uttarakhand. 16. ABSORBENT B. No.: 1857 Neps Drug Control RDTL COTTON WOOL I.P., Mfg dt: 06/2022 Department Guwahati 100Gms. Exp dt: 05/2025 Assam Mfd by: M/s. OM SURGICAL INDUSTRIES V.&P.O. TITOLI, JIND ROAD, ROHTAK-124001, HARYANA. 17. Proband B. No.: Rl 21006 Dissolution Drug Control RDTL (Albendazole Tablets Mfg dt: 06/2021 Department Guwahati IP 400mg) Exp dt: 05/2023 Jharkhand Mfd by: M/s. UPTAS LIFESCIENCE 211- Satyam Complex, Opp. JBR Arcade, Science City Road, Sola, Ahmedabad- 380060, Mfg. At: 33, Kamla Amruta Ind. Park, Indrad, Ta. Kadi, Dist. Mehsana- 382715, Gujarat. 18. Levocetirizine B. No.: LZR-2204 ‘pH’ Drug Control RDTL Dihydrochloride Syrup Mfg dt: 01/2022 Department Guwahati Exp dt: 12/2023 Bihar Page 4 of 19Mfd by: M/s. Apple Formulations Pvt. Ltd. Plot No. 208, Kishanpur, Roorkee- 247667, Uttarakhand. 19. Zincofine-20 DT B. No.: T-1E0108 Description Drug Control RDTL (Zinc Sulphate Mfg dt: 05/2021 Department Guwahati Dispersible Tablets IP Exp dt: 04/2023 Mizoram 20mg) Mfd by: M/s. MOREPAN LABORATORIES LTD. Morepan Village, Malkumajra, Baddi, Distt. Solan, Himachal Pradesh – 173205. 20. Zincofine-20 DT B. No.: T-1E0122 Description Drug Control RDTL (Zinc Sulphate Mfg dt: 05/2021 Department Guwahati Dispersible Tablets IP Exp dt: 04/2023 Mizoram 20mg) Mfd by: M/s. MOREPAN LABORATORIES LTD. Morepan Village, Malkumajra, Baddi, Distt. Solan, Himachal Pradesh – 173205. 21. Larkin®(Paracetamol B. No.: E-24 Dissolution Drug Control RDTL . Tablets IP) Mfg dt: 02/2022 Department Guwahati Exp dt: 01/2025 Mizoram Mfd by: M/s. Lark Laboratories (India) Ltd. Works at: SP- 1192 E, Phase-IV, RIICO Industrial Area, Bhiwadi- 301019, Distt. Alwar, Rajasthan. 22. Prazoto-DSR B. No.: S-22316 Dissolution Drug Control RDTL Capsules Mfg dt: 03/2022 (Pantoprazole) Department Guwahati (Pantoprazole Gastro- Exp dt: 11/2023 Jharkhand Resistant and Mfd by: M/s. Solace Domperidone Biotech Limited. Prolonged- release Address- At- 65, Capsules IP) Raipur, Bhagwanpur, Page 5 of 19Roorkee-247661, Distt- Haridwar (Uttarakhand). 23. Zenmax Tablets B. No.: CBT-122A/20 Dissolution Drug Control RDTL (Albendazole Tablets Mfg dt: 01/2021 Department Guwahati I.P.) Exp dt: 12/2022 Nagaland Mfd by: M/s. C.B. Healthcare, Distt. Solan 174101, Himachal Pradesh. 24. Ranitidine Oral B. No.: 2005 ASSAY Drug Control RDTL Solution I.P. 100mL Mfg dt: 02/2022 Department Guwahati Exp dt: 07/2023 Assam Mfd by: M/s. Vivimed Labs Limited, D-125 & 128, Phase III, I.D.A., Jeedimetla, Medchal-Malkajgiri Dist. Telangana State-500055. 25. Zenmax Tablets B. No.: CBT-714/21 Dissolution Drug Control RDTL (Albendazole Tablets Mfg dt: 11/2021 Department Guwahati I.P.) Exp dt: 10/2023 Nagaland Mfd by: M/s. C.B. Healthcare, Distt. Solan- Himachal Pradesh. 26. Calcium and Vitamin B. No.: MGCT2020 Identification Drug Control RDTL D3 Tablets I.P. Mfg dt: 12/2020 and Assay of Department Guwahati Meghalaya Exp dt: 11/2022 Vitamin D3 Mfd by: M/s. MODERN LABORATORIES 45- 47, Sector D-2, Sanwer Road, Indore, Madhya Pradesh, Pin-452015 INDIA. 27. PCD COLD® B. No.: GLT-21213 Disintegration Drug Control RDTL (Paracetamol, Mfg dt: 03/2021 Department Guwahati Phenylephrine HCl, Jharkhand Exp dt: 02/2024 Caffeine & Mfd by: M/s. GOPAL Diphenhydramine HCl LIFESCIENCES Tablets) (Unit-II), Hill Top Ind. Estate, Near Export Zone, Page 6 of 19Jharmajri, Baddi-173 205 (H.P.). 28. PARACETAMOL B. No.: PLA22004 Dissolution Drug Control RDTL TABLETS IP 500mg Mfg dt: 04/2022 Department Guwahati Mizoram Exp dt: 03/2024 Mfd by: M/s. Danish Healthcare (P) Ltd. 76/27-28, Industrial Estate, Maxi Road, Ujjain-456 010 INDIA. 29. Sensikast-LC Tablets B. No.: APT/04591 Identification Drug Control RDTL (Levocetirizine Mfg dt: 06/2021 and Department Guwahati Hydrochloride & Assay/Content Jharkhand Exp dt: 05/2023 Montelukast Sodium of Mfd by: M/s. AMKON Tablets) Levocetirizine PHARMACEUTICAL Dihydrochlorid S Plot No. 242, Ind. e and Area, Phase-IX, Montelukast S.A.S. Nagar, Mohali- 160062 (Punjab). 30. Montelukast Sodium B. No.: GM21075 Dissolution CDSCO CDL Tablets IP 5 mg Mfg dt: 08/2021 Guwahati Kolkata Exp dt: 07/2023 Mfd by: M/s. Skymap Pharmaceuticals Pvt. Ltd., B-3, Dev Bhoomi Industrial Estate, Puhana, Iqbalpur Road, Roorkee – 247 667, Uttarakhand. 31. Aluminium Hydroxide, B. No.: U2141 Assay of CDSCO CDL Magnesium Hydroxide Mfg dt: 12/2021 Polydimethyl- East Zone Kolkata & Activated Exp dt: 11/2023 siloxane Kolkata Dimethicone Tablets Mfd by: M/s. I.P. Universal Chemicals & Pharmaceutical Industries, 49, New Industrial Estate, Cuttack -754021 Odisha. 32. Gel MPS (Magnesium B. No.: T-0775/21 Assay of CDSCO CDL Hydroxide, Dried Mfg dt: 11/2021 Polydimethyl- East Zone Kolkata Aluminium Hydroxide siloxane Kolkata Exp dt: 10/2023 gel, Magnesium, Mfd by: M/s. Lucent Aluminium Silicate Biotech Limited, (Unit Hydrate & Activated Page 7 of 19Dimethicone Tablets) II), 165/3, Nalhera Anantapur, Roorkee, Distt. Haridwar Uttarakhand. 33. Aluminium Hydroxide, B. No.: ET21037 Assay of CDSCO CDL Magnesium Mfg dt: 01/2022 Polydimethyl- East Zone Kolkata Hydroxide& Activated siloxane Kolkata Exp dt: 12/2023 Dimethicone Mfd by: M/s. Eastern Tablets I.P. Chemical Industrial Pvt. Ltd., B-36, Industrial Estate, Cuttack – 753 010, Odisha. 34. Pantoprazole Gastro- B. No.: TDJ2010AL Dissolution CDSCO CDL Resistant Tablets IP Mfg dt: 03/2022 East Zone Kolkata 40 mg Kolkata Exp dt: 08/2023 Mfd by: M/s. Hindustan Laboratories Limited, Plot No. 5 - 9, Survey No. 38/2, Aliyalim Palghar(W), Dist. Palghar 401 404 Maharashtra. 35. Calcium and Vitamin B. No.: CWTY-201 Description, CDSCO CDL D3 Tablets I.P. Mfg dt: 12/2021 Dissolution of East Zone Kolkata (500 mg + 250 IU) Calcium & Kolkata Exp dt: 11/2023 Assay of Mfd by: M/s. Vitamin D3 Hindustan Antibiotics Ltd., At. 11, W.E.A. Faridabad - 121 001 Haryana. 36. Alprasafe - 0.5 B. No.: PE25AD01 Dissolution & CDSCO CDL (Alprazolam Tablets Mfg dt: 10/2021 Uniformity of East Zone Kolkata I.P. 0.5 mg) Exp dt: 03/2024 Content Kolkata Mfd by: M/s. Pure & Cure Healthcare Pvt. Ltd., Plot No. 26A, 27-30, Sector -8A, I.I.E. SIDCUL, Ranipur, Haridwar - 249 403, Uttarakhand. Page 8 of 1937. Cefoperazone & B. No.: 6400222 Particulate CDSCO CDL Sulbactam for Injection Mfg dt: 02/2022 Matter & East Zone Kolkata 2g Clarity of Kolkata Exp dt: 01/2024 solution Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Ltd., Plot No. 14, II Phase, Peenya, Bengaluru – 560 058. 38. Bupicain- Heavy 4 ml B. No.: BUI22003 Assay of CDSCO CDL (Bupivacaine Mfg dt: 04/2022 Dextrose East Zone Kolkata Hydrochloride with Kolkata Exp dt: 03/2024 Dextrose Injection Mfd by: M/s. Themis U.S.P.) Medicare Limited, Sector 6A, Plot No. 16,17 &18, IIE, SIDCUL, Haridwar – 249 403,Uttarakhand. 39. Diclopac (Diclofenac B. No.: APT/04682 Assay CDSCO CDL Potassium and Mfg dt: 07/2021 East Zone Kolkata Paracetamol Tablets) Kolkata Exp dt: 06/2023 Mfd by: M/s. Amkon Pharmaceuticals, Plot No. 242, Ind. Area, Phase-IX, S.A.S. Nagar, Mohali – 160 062, Punjab. 40. MONK – 4 B. No.: T2022 Disintegration CDSCO CDL (Montelukast Mouth Mfg dt: 07/2020 & Ahmedabad Kolkata Dissolving Tablets) Assay Exp dt: 06/2023 Mfd by: M/s. Picasso Remedies, 328/1, Kachigam, Daman – 396 215, (U.T.). 41. Albendazole Tablets IP B. No.: T3037 Dissolution CDSCO CDL 400 mg Mfg dt: 08/2022 Ahmedabad Kolkata Exp dt: 07/2024 Mfd by: M/s. Stallion Laboratories Pvt. Ltd., C-1B, 305/2, 3, 4 & 5, G.I.D.C. Kerala (Bavla), Dist. Ahmedabad -382 220, Gujarat, India. Page 9 of 1942. Frusemide Injection B. No.: FR12223 Sterility CDSCO CDL I.P. 2ml Mfg dt: 07/2022 Ahmedabad Kolkata Exp dt: 06/2024 Mfd by: M/s. Nandani Medical Laboratories Pvt. Ltd., 221/5, Bicholi Hapsi Kanadla Road, Indore. 43. Sodium Valproate B. No.: T2240 Related CDSCO CDL Tablets IP 500 mg Mfg dt: 07/2022 Substances Ahmedabad Kolkata Exp dt: 06/2024 Mfd by: M/s. Bharat Parenterals Ltd., Vill. Haripura, Ta. Savli, Dist. Vadodara -391 520, Gujarat. 44. B-fine OD (Doxylamine B. No.: JT-048 Disintegration CDSCO CDL Succinate, Pyridoxine Mfg dt: 05/2022 Ahmedabad Kolkata HCl & Folic Acid Exp dt: 04/2024 Tablets) Mfd by: M/s. Jainsons Healthcare, Plot No. 32, Sector No.-6, IIE, Pantnagar, Dist. U. S. Nagar, Uttarakhand- 263153. 45. Bupivacaine B. No.: I-1088 Description, Drug Control CDL Hydrochloride Injection Mfg dt: 07/2021 Particulate Department Kolkata IP (0.5% w/v) – 20 ml Matter & Odisha Exp dt: 06/2023 Sterility Mfd by: M/s. Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar – 143 001 Punjab India. 46. RL-500ml, Compound B. No.: 203042 Bacterial Drug Control CDL Sodium Lactate Mfg dt: 03/2022 Endotoxins Department Kolkata Injection IP (Ringer & Odisha Exp dt: 02/2024 Lactate Solution for Sterility Mfd by: M/s. Ives Injection I.P.) Drugs (India) Pvt. Ltd., Works: Ghatabillod, Distt. Dhar, H.O. 504, Chetak Centre, RNT Marg, Indore – 1 Page 10 of 19(India). 47. PROPOSOL B. No.: PNL-220505 Assay Drug Control CDL INJECTION Mfg dt: 05/2022 Department Kolkata 10 ml (Propofol Himachal Exp dt: 04/2024 Emulsion for Pradesh Mfd by: M/s. Nixi Injection IP Laboratories Pvt. 10mg /ml) Ltd., VPO: Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour, 173 030 Himachal Pradesh. 48. Nexofol Injection 20 ml B. No.: PNL-220514 Assay Drug Control CDL (Propofol Emulsion for Mfg dt: 05/2022 Department Kolkata Injection IP 10 mg/ml) Himachal Exp dt: 04/2024 Pradesh Mfd by: M/s. Nixi Laboratories Pvt. Ltd., VPO: Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour, 173030, Himachal Pradesh. 49. Mepdofol Injection 20 B. No.: PNL-220043 Assay Drug Control CDL ml (Propofol Emulsion Mfg dt: 02/2022 Department Kolkata for Injection IP Exp dt: 01/2024 Himachal 10 mg/ml) Pradesh Mfd by: M/s. Nixi Laboratories Pvt. Ltd., VPO: Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour, 173 030, Himachal Pradesh. 50. Nexofol Injecion B. No.: PNL-220507 Assay Drug Control CDL (Propofol Emulsion for Mfg dt: 05/2022 Department Kolkata Injection IP 10 mg/ml) Himachal Exp dt: 04/2024 Pradesh Mfd by: M/s. Nixi Laboratories Pvt. Ltd., VPO: Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour, 173 030, Himachal Pradesh. 51. Pfolol-20 Injection B. No.: PNL-220515 Assay Drug Control CDL (Propofol Emulsion for Mfg dt: 05/2022 Department Kolkata Injection IP 10mg/ml) Himachal Exp dt: 04/2024 Pradesh Mfd by: M/s. Nixi Page 11 of 19Laboratories Pvt. Ltd., VPO: Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour, 173 030, Himachal Pradesh. 52. PROPOSOL B. No.: PNL-220421 Assay Drug Control CDL INJECTION, 20 ml Mfg dt: 04/2022 Department Kolkata (Propofol Emulsion for Himachal Exp dt: 03/2024 Injection IP 10mg/ml) Pradesh Mfd by: M/s. Nixi Laboratories Pvt. Ltd., VPO: Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour, 173 030, Himachal Pradesh. 53. PROZOFOL B. No.: PNL-220420 Assay Drug Control CDL INJECTION, 20 ml Mfg dt: 04/2022 Department Kolkata (Propofol Emulsion for Himachal Exp dt: 03/2024 Injection IP 10 mg/ml) Pradesh Mfd by: M/s. Nixi Laboratories Pvt. Ltd., VPO: Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour, 173 030, Himachal Pradesh. 54. Compound Sodium B. No.: 2105B0222 Sterility CDSCO CDL Lactate Injection I.P. Mfg dt: 02/2021 Hyderabad Kolkata (RL)500 ml Exp dt: 01/2024 Mfd by: M/s. Pharma Impex Laboratories Pvt. Ltd., South Uttarbhag, Ramnagar, Baruipur, Dist. South 24 Pgs, West Bengal - 743387, India. 55. Compound Sodium B. No.: 2105B0223 Sterility CDSCO CDL Lactate Injection I.P. Mfg dt: 03/2021 Hyderabad Kolkata (RL)500 ml Exp dt: 02/2024 Mfd by: M/s. Pharma Impex Laboratories Pvt. Ltd., South Uttarbhag, Page 12 of 19Ramnagar, Baruipur, Dist. South 24 Pgs, West Bengal - 743387, India 56. Compound Sodium B. No.: 2105B0225 Sterility CDSCO CDL Lactate Injection I.P. Mfg dt: 03/2021 Hyderabad Kolkata (RL)500 ml Exp dt: 02/2024 Mfd by: M/s. Pharma Impex Laboratories Pvt. Ltd., South Uttarbhag, Ramnagar, Baruipur, Dist. South 24 Pgs, West Bengal - 743387, India 57. Compound Sodium B. No.: 2105B0159 Sterility CDSCO CDL Lactate Injection I.P. Mfg dt: 02/2021 Hyderabad Kolkata (RL)500 ml Exp dt: 01/2024 Mfd by: M/s. Pharma Impex Laboratories Pvt. Ltd., South Uttarbhag, Ramnagar, Baruipur, Dist. South 24 Pgs, West Bengal - 743387, India 58. Compound Sodium B. No.: 2105B0160 Sterility CDSCO CDL Lactate Injection I.P. Mfg dt: 02/2021 Hyderabad Kolkata (RL)500 ml Exp dt: 01/2024 Mfd by: M/s. Pharma Impex Laboratories Pvt. Ltd., South Uttarbhag, Ramnagar, Baruipur, Dist. South 24 Pgs, West Bengal - 743387, India 59. Methodol -16 B. No.: MHD2201 Dissolution CDSCO CDL (Methylpredinisolone Mfg dt: 02/2022 East Zone Kolkata Tablets I.P.) Kolkata Exp dt: 01/2024 Mfd by: M/s. Apple Formulation Pvt. Ltd., Plot No. 208, Kishanpur, Roorkee – Page 13 of 19247 667, Uttarakhand. 60. Cefpodoxime Proxetil B. No.: UCT-22159 Uniformity of CDSCO CDL Dispersible Tablets Mfg dt: 05/2022 Dispersion East Zone Kolkata 200 mg Kolkata Exp dt: 04/2024 Mfd by: M/s. Ultra Drugs Pvt. Ltd., Plot No. 1315-1318, Manpura, Nalagarh, Distt. Solan , Himachal Pradesh . - 174101 61. Propoven Injection-20 B. No.: PNL-210005 Assay Drug Control CDL ml (Propofol Emulsion Mfg dt: 12/2021 Department Kolkata for Injection IP Himachal Exp dt: 11/2023 10mg/ml) Pradesh Mfd by: M/s. Nixi Laboratories Pvt. Ltd., VPO: Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour, 173 030, Himachal Pradesh. 62. Neostigmine Injection B. No.: NM22L2 Description, CDSCO CDL I.P. 0.5 mg /ml Mfg dt: 07/2022 Particulate Ahmedabad Kolkata Matter & Exp dt: 06/2024 Assay Mfd by: M/s. Acro Lifesciences (India) Pvt. Ltd., C - 86, M.I.D.C., Hingna, Nagpur – 16, Maharashtra. 63. Chlorpheniramine B. No.: 745 Related CDSCO CDL Maleate Tablets I.P. Mfg dt: 07/2022 Substances Ahmedabad Kolkata 4 mg Exp dt: 06/2024 Mfd by: M/s. Deep Pharma, Khedut Sabha Building, Dholka - 382225, Ahmedabad. 64. Ceftal (Ceftriaxone B. No.: UNI-210194 Particulate Drug Control CDL Injection I.P.) Mfg dt: 03/2022 Matter, Clarity Department Kolkata of Solution & Jharkhand Exp dt: 02/2024 Assay Mfd by: M/s. Unital Formulations (A GMP Page 14 of 19Certified Company) Plot No. 114-B, EPIP, Phase -1, Jharmajri,, Baddi, Dist. Solan, Himachal Pradesh. 65. Ropula Injection-20 ml B. No.: NADPF1C Assay Drug Control CDL (Propofol Emulsion for Mfg dt: 06/2022 Department Kolkata Injection IP 10mg/ml) Himachal Exp dt: 05/2024 Pradesh Mfd by: M/s. Nixi Laboratories Pvt. Ltd., VPO Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour - 173 030, Himachal Pradesh. 66. Propoven Injection-20 B. No.: NADPF1A Assay Drug Control CDL ml (Propofol Emulsion Mfg dt: 06/2022 Department Kolkata for Injection IP Himachal Exp dt: 05/2024 10 mg/ml) Pradesh Mfd by: M/s. Nixi Laboratories Pvt. Ltd., VPO Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour - 173 030, Himachal Pradesh. 67. Pufolin Injection- 20 ml B. No.: NADPF1B Assay Drug Control CDL (Propofol Emulsion for Mfg dt: 06/2022 Department Kolkata Injection IP 10 mg/ml) Himachal Exp dt: 05/2024 Pradesh Mfd by: M/s. Nixi Laboratories Pvt. Ltd., VPO Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour - 173 030, Himachal Pradesh. 68. Pfolol-10 Injection-10 B. No.: NADOG1C Assay Drug Control CDL ml (Propofol Emulsion Mfg dt: 07/2022 Department Kolkata for Injection IP Himachal Exp dt: 06/2024 10 mg/ml), Pradesh Mfd by: M/s. Nixi Laboratories Pvt. Ltd., VPO Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour - 173 030, Page 15 of 19Himachal Pradesh. 69. Nenfol Injection-10 ml B. No.: NADOG1A Assay Drug Control CDL (Propofol Injection BP Mfg dt: 07/2022 Department Kolkata 10mg/ml) Himachal Exp dt: 06/2024 Pradesh Mfd by: M/s. Nixi Laboratories Pvt. Ltd., VPO Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour - 173 030, Himachal Pradesh. 70. MIDZOCULE 10 B. No.: BLMZ121001 pH and Assay CDSCO CDL Injection (Midazolam Mfg dt: 07/2021 South Zone Kolkata Injection I.P. 1mg/ml Chennai Exp dt: 06/2023 Mfd by: M/s. Safe Parenterals Pvt. Ltd., Gollapadu-522408, Guntur Distt. Andhra Pradesh, India. 71. Ciprofloxacin Tablets B. No.: CPT22006 Dissolution CDSCO CDTL IP 500 mg Mfg dt: 05/2022 South Zone Chennai Exp dt: 04/2024 Mfd by: M/s. Vivek Pharmachem (India) Limited, NH-8, Chimanpura, Amer, Jaipur – 303102 Rajasthan. 72. Zinc Sulphate B. No.: ZST922 Assay CDSCO CDTL Dispersible Tablets IP Mfg dt: 02/2022 Subzone Chennai 20 mg Bangalore Exp dt: 01/2024 Mfd by: M/s. Unicure India Ltd., C-21, 22 & 23, Sector – 3, Noida – 201301 Distt. Gautam Budh Nagar, Uttar Pradesh. 73. Rabeprazole Sodium B. No.: RBM-501 Assay CDSCO CDTL Tablets I.P. Mfg dt: 04/2022 Sub- Zone Mumbai Indore Exp dt: 03/2024 Mfd by: M/s. Healer’s Lab., Unit-II, Plot No.33, H.P.S.I.D.C., Extn., Baddi, Distt- Solan, Himachal Page 16 of 19Pradesh. 74. Gabapentin Capsules B. No.: 1721-625 Related CDSCO RDTL IP 300 mg (GABATIX- Mfg dt: 11/2021 Substances Sub-Zone Chandigarh 300 CAPSULES) Baddi Exp dt: 10/2024 Mfd by: M/s. ZEE LABORATORIES LTD. Behind 47, Industrial Area, Paonta Sahib-173205 Himachal Pradesh. 75. Ondansetron B. No.: ONTZ-07 Assay CDSCO RDTL Tablets IP 4 mg Mfg dt: 04/2022 North Zone Chandigarh Exp dt: 03/2024 Mfd by: M/s. NESTOR PHARMACEUTICAL S LIMITED, 11, Western Extension Area, Faridabad- 121001, Haryana INDIA. 76. Cefoperazone and B. No.: SRI22-011R3 Clarity and CDSCO RDTL Sulbactam For Mfg dt: 06/2022 Colour of North Zone Chandigarh Injection (Suf-DT Solution, Exp dt: 05/2024 Injection) Water and Mfd by: M/s. Subham Assay of Remedies, Khasra Sulbactam No-169, Tanshipur, sodium Roorkee, Uttarakhand. 77. Ramipril Tablets IP B. No.: RMFT905 Assay of CDSCO RDTL 5.0 mg Mfg dt: 10/2021 Ramipril North Zone Chandigarh Exp dt: 09/2023 Mfd by: M/s. Unicure India Ltd., C-21,22 and 23, Sector-3, Noida-201301 Distt. GautamBudh Nagar Uttar Pradesh. 78. Tolperisone B. No.: TSB-501 Assay CDSCO RDTL Hydrochloride Tablets Mfg dt: 12/2021 North Zone Chandigarh 150 mg Exp dt: 11/2023 Mfd by: M/s. Healers Page 17 of 19Lab Unit II, Plot No. 33, H.P.S.I.D.C., Extn.Baddi, Distt- Solan, Himachal Pradesh. 79. Clopidogrel Tablets IP B. No.: CPDT21002 Assay CDSCO RDTL 75 mg Mfg dt: 08/2021 North Zone Chandigarh Exp dt: 07/2023 Mfd by: M/s. Ravian Life Sciences Pvt.Ltd., Plot No. 34, Sector-8A, IIE, SIDCUL, Haridwar- 249403, Uttarakhand, INDIA. 80. Propofol Emulsion for B. No.: PNL-220513 Assay CDSCO RDTL Injection IP 10 mg/ml Mfg dt: 05/2022 Sub-Zone Chandigarh (Propoven Injection) Baddi Exp dt: 04/2024 Mfd by: M/s. Nixi Laboratories Pvt. Ltd, VPO. MouzaOgli, Sadhaura Road, Kala-Amb, Distt Sirmour-173030 Himachal Pradesh. 81. Bisacodyl Tablets IP B. No.: DT2H005 Assay CDSCO RDTL (Dulax Tablets) Mfg dt: 08/2022 North Zone Chandigarh Exp dt: 07/2025 Mfd by: M/s. Scott- Edil Pharmacia Ltd., 56, E.P.I.P., Phase-1, Jharmajri, Baddi, Distt. Solan-173205 Himachal Pradesh INDIA. 82. Bisacodyl Tablets IP B. No.: 12235 Dissolution CDSCO RDTL 5 mg (Bicolax- Mfg dt: 12/2020 test (Buffer North Zone Chandigarh 5 Tablets) Stage) and Exp dt: 11/2023 Assay Mfd by: M/s. ELIKEM PHARMACEUTICAL S PVT. LTD., 816/1, Rakanpur, Ta. Kalol, Dist. Gandhinagar, Gujarat. India Page 18 of 1983. Domperidone Tablets B. No.: GSM0040 Identification CDSCO RDTL IP 10 mg (Domcolic Mfg dt: 10/2021 North Zone Chandigarh Tablets) Exp dt: 09/2023 Mfd by: M/s. Skymap Pharmaceuticals Pvt. Ltd., B-3, Dev Bhoomi Industrial Estate Puhana Iqbalpur Road, Roorkee – 247667 Uttarakhand. Page 19 of 19

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