83 Drug Samples Fail To Qualify CDSCO Test
New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 83 medicine batches for failing to qualify for a random drug sample test for the month of November, 2022.
These drugs samples which are declared not of standard quality include Pantop-DSR (Pantoprazole Sodium Gastro-resistant & Domperidone Prolonged- release Capsules IP) manufactured by Aristo Pharmaceuticals, SHELCAL®-500 (Calcium And Vitamin D3 Tablets I.P.) manufactured by Pure and Cure Healthcare, Paracetamol Tablets IP 650mg manufactured by ANG Lifesciences India, Montelukast Sodium Tablets IP 5 mg manufactured by Skymap Pharmaceuticals and others.
In addition, the list includes Bupivacaine Hydrochloride Injection IP (0.5% w/v) – 20 ml manufactured by Jackson Laboratories, Gabapentin Capsules IP 300 mg (GABATIX- 300 CAPSULES) manufactured by Zee laboratories, Domperidone Tablets IP 10 mg (Domcolic Tablets) manufactured by Skymap Pharmaceuticals and etc.
Apart from the above, other popular drug sample that is declared not of standard quality include Sodium Valproate Tablets IP 500 mg manufactured by Bharat Parenterals.
Also Read:59 Drug Samples Including Cadila pharma Aciloc 150 Fail To Qualify CDSCO Test
This came after analysis and tests conducted by the CDSCO, Drugs Control Department on 1487 samples. Out of these, 1404 samples were found to be of standard quality while 83 of them were declared as Not of Standard Quality (NSQ).
A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the disintegration test, failure of the dissolution test, failure of sterility test, etc.
The samples collected were tested in five laboratories, namely CDTL Chennai, RDTL Chandigarh, CDTL Mumbai, CDL Kolkata, RDTL Guwahati.
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 Drugs/medical device/cosmetics | Batch No./Date of Manufacture/Date of Expiry/Manufacture d By | Reason for failure | Drawn By | From |
1. | Ibuprofen Oral Suspension B.P., 60ml | B. No.: IPS6-21-221 Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s. ORNATE LABS PVT. LTD., Bela Industrial Estate, Muzaffarpur- 842005, Bihar. | 'pH' | Drug Control Department Bihar | RDTL Guwahati |
2. | Telmisartan Tablets IP 40 mg | B. No.: T101006 Mfg dt: 09/2021 Exp dt: 08/2023 Mfd by: M/s. ANG Lifesciences India Ltd.,Village Malkumajra, Nalagarh Road, Baddi, Distt. Solan- 173205, Himachal Pradesh. | Description | Drug Control Department Bihar | RDTL Guwahati |
3. | Pantop-DSR® (Pantoprazole Sodium Gastro-resistant & Domperidone Prolonged- release Capsules IP) | B. No.: SPA220030 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. ARISTO Pharmaceuticals Private Limited, Plot Nos.: 2040-46, N.H. 10, Baghey Khola, P.O. Majhitar, East – Sikkim, 737 136. | Identification and Assay/ Content of 'Pantoprazole and Domperidone' | Drug Control Department Mizoram | RDTL Guwahati |
4. | Norfloxacin and Tinidazole Tablets (Norflox-TZ RF) | B. No.: STC21450 Mfg dt: 09/2021 Exp dt: 08/2024 | Identification & Assay | Drug Control Department Assam | RDTL Guwahati |
Mfd 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. |
9. | SHELCAL®-500 (Calcium And Vitamin D3 Tablets I.P.) | B. No.: 8LV2H077 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. Pure and Cure Healthcare Pvt. Ltd. Plot No. 26A-30, Sector-8A, IIE SIDCUL, Ranipur, Haridwar-249 403, Uttarakhand. | Identification of Vitamin D3, Dissolution (Calcium) and Assay of Elemental Calcium & Vitamin D3 | Drug Control Department Assam | RDTL Guwahati |
10. | PQUIN-2.5 (Primaquine Phosphate Tablets IP 2.5 mg) | B. No.: CN2102 Mfg dt: 09/2021 Exp dt: 08/2023 Mfd by: M/s. CENTURY DRUGS PVT. LTD. Plot No. 38, Sector-3, Pithampur, Dist.- Dhar. Madhya Pradesh. | Dissolution and Assay | Drug Control Department Jharkhand | RDTL Guwahati |
11. | Pantop- D SR® (Pantoprazole Sodium Gastro-resistant & Domperidone Prolonged-release Capsules IP) | B. No.: SPJ211372 Mfg dt: 09/2021 Exp dt: 08/2023 Mfd by: M/s. ARISTO Pharmaceuticals Private Limited Plot Nos.: 2040-46, N.H. 10, Baghey Khola, P.O. Majhitar, East-Sikkim, 737 136. | Identification and Assay/Content of Pantoprazole & Domperidone and Description | Drug Control Department Mizoram | RDTL Guwahati |
12. | DICLORIN PLUS (Diclofenac Sodium & Paracetamol Tablets) | B. No.: DR-152 Mfg dt: 09/2021 Exp dt: 08/2024 Mfd by: M/s. ANDISONS PHARMIX, Bhagwati Sadan, Mahabir Path, Lohanipur, Patna – 800 003, Bihar. | Uniformity of weight of Tablet and Assay of Paracetamol | Drug Control Department Bihar | RDTL Guwahati |
13. | Levocetirizine Dihydrochloride Syrup. 30 ml | B. No.: LZR-2202 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. Apple Formulations Pvt. Ltd. Plot No. 208, Kishanpur, Roorkee- | 'pH' | Drug Control Department Bihar | RDTL Guwahati |
247667, 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 Dihydrochloride Syrup (30 ml) | B. No.: LZR-2207 Mfg dt: 01/2022 Exp dt: 12/2023 | 'pH' | Drug Control Department Bihar | RDTL Guwahati |
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 (Albendazole Tablets | B. No.: Rl 21006 Mfg dt: 06/2021 | Dissolution | Drug Control Department | RDTL 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 Dihydrochloride Syrup | B. No.: LZR-2204 Mfg dt: 01/2022 Exp dt: 12/2023 | 'pH' | Drug Control Department Bihar | RDTL Guwahati |
Mfd by: M/s. Apple Formulations Pvt. Ltd. Plot No. 208, Kishanpur, Roorkee- 247667, Uttarakhand. | |||||
19. | Zincofine-20 DT (Zinc Sulphate | B. No.: T-1E0108 Mfg dt: 05/2021 | Description | Drug Control Department | RDTL 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 (Zinc Sulphate | B. No.: T-1E0122 Mfg dt: 05/2021 | Description | Drug Control Department | RDTL 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 Tablets IP) | B. No.: E-24 Mfg dt: 02/2022 | Dissolution | Drug Control Department | RDTL 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 Capsules (Pantoprazole Gastro- Resistant and | B. No.: S-22316 Mfg dt: 03/2022 Exp dt: 11/2023 Mfd by: M/s. Solace Biotech Limited. Address- At- 65, Raipur, Bhagwanpur, | Dissolution (Pantoprazole) | Drug Control Department Jharkhand | RDTL Guwahati |
Domperidone | |||||
Prolonged- release | |||||
Capsules IP) |
Roorkee-247661, Distt- Haridwar (Uttarakhand). | |||||
23. | Zenmax Tablets (Albendazole Tablets I.P.) | B. No.: CBT-122A/20 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s. C.B. Healthcare, Distt. Solan 174101, Himachal Pradesh. | Dissolution | Drug Control Department Nagaland | RDTL Guwahati |
24. | Ranitidine Oral Solution I.P. 100mL | B. No.: 2005 Mfg dt: 02/2022 Exp dt: 07/2023 Mfd by: M/s. Vivimed Labs Limited, D-125 & 128, Phase III, I.D.A., Jeedimetla, Medchal-Malkajgiri Dist. Telangana State-500055. | ASSAY | Drug Control Department Assam | RDTL Guwahati |
25. | Zenmax Tablets (Albendazole Tablets I.P.) | B. No.: CBT-714/21 Mfg dt: 11/2021 Exp dt: 10/2023 Mfd by: M/s. C.B. Healthcare, Distt. Solan- Himachal Pradesh. | Dissolution | Drug Control Department Nagaland | RDTL Guwahati |
26. | Calcium and Vitamin D3 Tablets I.P. | B. No.: MGCT2020 Mfg dt: 12/2020 Exp dt: 11/2022 Mfd by: M/s. MODERN LABORATORIES 45- 47, Sector D-2, Sanwer Road, Indore, Madhya Pradesh, Pin-452015 INDIA. | Identification and Assay of Vitamin D3 | Drug Control Department Meghalaya | RDTL Guwahati |
27. | PCD COLD® (Paracetamol, Phenylephrine HCl, Caffeine & Diphenhydramine HCl Tablets) | B. No.: GLT-21213 Mfg dt: 03/2021 Exp dt: 02/2024 Mfd by: M/s. GOPAL LIFESCIENCES (Unit-II), Hill Top Ind. Estate, Near Export Zone, | Disintegration | Drug Control Department Jharkhand | RDTL Guwahati |
Jharmajri, Baddi-173 205 (H.P.). | |||||
28. | PARACETAMOL TABLETS IP 500mg | B. No.: PLA22004 Mfg dt: 04/2022 Exp dt: 03/2024 Mfd by: M/s. Danish Healthcare (P) Ltd. 76/27-28, Industrial Estate, Maxi Road, Ujjain-456 010 INDIA. | Dissolution | Drug Control Department Mizoram | RDTL Guwahati |
29. | Sensikast-LC Tablets (Levocetirizine Hydrochloride & Montelukast Sodium Tablets) | B. No.: APT/04591 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. AMKON PHARMACEUTICAL S Plot No. 242, Ind. Area, Phase-IX, S.A.S. Nagar, Mohali- 160062 (Punjab). | Identification and Assay/Content of Levocetirizine Dihydrochlorid e and Montelukast | Drug Control Department Jharkhand | RDTL Guwahati |
30. | Montelukast Sodium Tablets IP 5 mg | B. No.: GM21075 Mfg dt: 08/2021 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. | Dissolution | CDSCO Guwahati | CDL Kolkata |
31. | Aluminium Hydroxide, Magnesium Hydroxide & Activated Dimethicone Tablets I.P. | B. No.: U2141 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. Universal Chemicals & Pharmaceutical Industries, 49, New Industrial Estate, Cuttack -754021 Odisha. | Assay of Polydimethyl- siloxane | CDSCO East Zone Kolkata | CDL Kolkata |
32. | Gel MPS (Magnesium Hydroxide, Dried Aluminium Hydroxide gel, Magnesium, Aluminium Silicate Hydrate & Activated | B. No.: T-0775/21 Mfg dt: 11/2021 Exp dt: 10/2023 Mfd by: M/s. Lucent Biotech Limited, (Unit | Assay of Polydimethyl- siloxane | CDSCO East Zone Kolkata | CDL Kolkata |
Dimethicone Tablets) | II), 165/3, Nalhera Anantapur, Roorkee, Distt. Haridwar Uttarakhand. | ||||
33. | Aluminium Hydroxide, Magnesium Hydroxide& Activated Dimethicone Tablets I.P. | B. No.: ET21037 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. Eastern Chemical Industrial Pvt. Ltd., B-36, Industrial Estate, Cuttack – 753 010, Odisha. | Assay of Polydimethyl- siloxane | CDSCO East Zone Kolkata | CDL Kolkata |
34. | Pantoprazole Gastro- Resistant Tablets IP 40 mg | B. No.: TDJ2010AL Mfg dt: 03/2022 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. | Dissolution | CDSCO East Zone Kolkata | CDL Kolkata |
35. | Calcium and Vitamin D3 Tablets I.P. (500 mg + 250 IU) | B. No.: CWTY-201 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. Hindustan Antibiotics Ltd., At. 11, W.E.A. Faridabad - 121 001 Haryana. | Description, Dissolution of Calcium & Assay of Vitamin D3 | CDSCO East Zone Kolkata | CDL Kolkata |
36. | Alprasafe - 0.5 (Alprazolam Tablets I.P. 0.5 mg) | B. No.: PE25AD01 Mfg dt: 10/2021 Exp dt: 03/2024 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. | Dissolution & Uniformity of Content | CDSCO East Zone Kolkata | CDL Kolkata |
37. | Cefoperazone & Sulbactam for Injection 2g | B. No.: 6400222 Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Ltd., Plot No. 14, II Phase, Peenya, Bengaluru – 560 058. | Particulate Matter & Clarity of solution | CDSCO East Zone Kolkata | CDL Kolkata |
38. | Bupicain- Heavy 4 ml (Bupivacaine Hydrochloride with Dextrose Injection U.S.P.) | B. No.: BUI22003 Mfg dt: 04/2022 Exp dt: 03/2024 Mfd by: M/s. Themis Medicare Limited, Sector 6A, Plot No. 16,17 &18, IIE, SIDCUL, Haridwar – 249 403,Uttarakhand. | Assay of Dextrose | CDSCO East Zone Kolkata | CDL Kolkata |
39. | Diclopac (Diclofenac Potassium and Paracetamol Tablets) | B. No.: APT/04682 Mfg dt: 07/2021 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. | Assay | CDSCO East Zone Kolkata | CDL Kolkata |
40. | MONK – 4 (Montelukast Mouth Dissolving Tablets) | B. No.: T2022 Mfg dt: 07/2020 Exp dt: 06/2023 Mfd by: M/s. Picasso Remedies, 328/1, Kachigam, Daman – 396 215, (U.T.). | Disintegration & Assay | CDSCO Ahmedabad | CDL Kolkata |
41. | Albendazole Tablets IP 400 mg | B. No.: T3037 Mfg dt: 08/2022 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. | Dissolution | CDSCO Ahmedabad | CDL Kolkata |
42. | Frusemide Injection I.P. 2ml | B. No.: FR12223 Mfg dt: 07/2022 Exp dt: 06/2024 Mfd by: M/s. Nandani Medical Laboratories Pvt. Ltd., 221/5, Bicholi Hapsi Kanadla Road, Indore. | Sterility | CDSCO Ahmedabad | CDL Kolkata |
43. | Sodium Valproate Tablets IP 500 mg | B. No.: T2240 Mfg dt: 07/2022 Exp dt: 06/2024 Mfd by: M/s. Bharat Parenterals Ltd., Vill. Haripura, Ta. Savli, Dist. Vadodara -391 520, Gujarat. | Related Substances | CDSCO Ahmedabad | CDL Kolkata |
44. | B-fine OD (Doxylamine Succinate, Pyridoxine HCl & Folic Acid Tablets) | B. No.: JT-048 Mfg dt: 05/2022 Exp dt: 04/2024 Mfd by: M/s. Jainsons Healthcare, Plot No. 32, Sector No.-6, IIE, Pantnagar, Dist. U. S. Nagar, Uttarakhand- 263153. | Disintegration | CDSCO Ahmedabad | CDL Kolkata |
45. | Bupivacaine Hydrochloride Injection IP (0.5% w/v) – 20 ml | B. No.: I-1088 Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s. Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar – 143 001 Punjab India. | Description, Particulate Matter & Sterility | Drug Control Department Odisha | CDL Kolkata |
46. | RL-500ml, Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection I.P.) | B. No.: 203042 Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. Ives Drugs (India) Pvt. Ltd., Works: Ghatabillod, Distt. Dhar, H.O. 504, Chetak Centre, RNT Marg, Indore – 1 | Bacterial Endotoxins & Sterility | Drug Control Department Odisha | CDL Kolkata |
(India). | |||||
47. | PROPOSOL INJECTION 10 ml (Propofol Emulsion for Injection IP 10mg /ml) | B. No.: PNL-220505 Mfg dt: 05/2022 Exp dt: 04/2024 Mfd by: M/s. Nixi Laboratories Pvt. Ltd., VPO: Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour, 173 030 Himachal Pradesh. | Assay | Drug Control Department Himachal Pradesh | CDL Kolkata |
48. | Nexofol Injection 20 ml (Propofol Emulsion for Injection IP 10 mg/ml) | B. No.: PNL-220514 Mfg dt: 05/2022 Exp dt: 04/2024 Mfd by: M/s. Nixi Laboratories Pvt. Ltd., VPO: Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour, 173030, Himachal Pradesh. | Assay | Drug Control Department Himachal Pradesh | CDL Kolkata |
49. | Mepdofol Injection 20 ml (Propofol Emulsion for Injection IP 10 mg/ml) | B. No.: PNL-220043 Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s. Nixi Laboratories Pvt. Ltd., VPO: Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour, 173 030, Himachal Pradesh. | Assay | Drug Control Department Himachal Pradesh | CDL Kolkata |
50. | Nexofol Injecion (Propofol Emulsion for Injection IP 10 mg/ml) | B. No.: PNL-220507 Mfg dt: 05/2022 Exp dt: 04/2024 Mfd by: M/s. Nixi Laboratories Pvt. Ltd., VPO: Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour, 173 030, Himachal Pradesh. | Assay | Drug Control Department Himachal Pradesh | CDL Kolkata |
51. | Pfolol-20 Injection (Propofol Emulsion for Injection IP 10mg/ml) | B. No.: PNL-220515 Mfg dt: 05/2022 Exp dt: 04/2024 Mfd by: M/s. Nixi | Assay | Drug Control Department Himachal Pradesh | CDL Kolkata |
Laboratories Pvt. Ltd., VPO: Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour, 173 030, Himachal Pradesh. | |||||
52. | PROPOSOL INJECTION, 20 ml (Propofol Emulsion for Injection IP 10mg/ml) | B. No.: PNL-220421 Mfg dt: 04/2022 Exp dt: 03/2024 Mfd by: M/s. Nixi Laboratories Pvt. Ltd., VPO: Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour, 173 030, Himachal Pradesh. | Assay | Drug Control Department Himachal Pradesh | CDL Kolkata |
53. | PROZOFOL INJECTION, 20 ml (Propofol Emulsion for Injection IP 10 mg/ml) | B. No.: PNL-220420 Mfg dt: 04/2022 Exp dt: 03/2024 Mfd by: M/s. Nixi Laboratories Pvt. Ltd., VPO: Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour, 173 030, Himachal Pradesh. | Assay | Drug Control Department Himachal Pradesh | CDL Kolkata |
54. | Compound Sodium Lactate Injection I.P. (RL)500 ml | B. No.: 2105B0222 Mfg dt: 02/2021 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. | Sterility | CDSCO Hyderabad | CDL Kolkata |
55. | Compound Sodium Lactate Injection I.P. (RL)500 ml | B. No.: 2105B0223 Mfg dt: 03/2021 Exp dt: 02/2024 Mfd by: M/s. Pharma Impex Laboratories Pvt. Ltd., South Uttarbhag, | Sterility | CDSCO Hyderabad | CDL Kolkata |
Ramnagar, Baruipur, Dist. South 24 Pgs, West Bengal - 743387, India | |||||
56. | Compound Sodium Lactate Injection I.P. (RL)500 ml | B. No.: 2105B0225 Mfg dt: 03/2021 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 | Sterility | CDSCO Hyderabad | CDL Kolkata |
57. | Compound Sodium Lactate Injection I.P. (RL)500 ml | B. No.: 2105B0159 Mfg dt: 02/2021 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 | Sterility | CDSCO Hyderabad | CDL Kolkata |
58. | Compound Sodium Lactate Injection I.P. (RL)500 ml | B. No.: 2105B0160 Mfg dt: 02/2021 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 | Sterility | CDSCO Hyderabad | CDL Kolkata |
59. | Methodol -16 (Methylpredinisolone Tablets I.P.) | B. No.: MHD2201 Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s. Apple Formulation Pvt. Ltd., Plot No. 208, Kishanpur, Roorkee – | Dissolution | CDSCO East Zone Kolkata | CDL Kolkata |
247 667, Uttarakhand. | |||||
60. | Cefpodoxime Proxetil Dispersible Tablets 200 mg | B. No.: UCT-22159 Mfg dt: 05/2022 Exp dt: 04/2024 Mfd by: M/s. Ultra Drugs Pvt. Ltd., Plot No. 1315-1318, Manpura, Nalagarh, Distt. Solan , Himachal Pradesh . - 174101 | Uniformity of Dispersion | CDSCO East Zone Kolkata | CDL Kolkata |
61. | Propoven Injection-20 ml (Propofol Emulsion for Injection IP 10mg/ml) | B. No.: PNL-210005 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. Nixi Laboratories Pvt. Ltd., VPO: Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour, 173 030, Himachal Pradesh. | Assay | Drug Control Department Himachal Pradesh | CDL Kolkata |
62. | Neostigmine Injection I.P. 0.5 mg /ml | B. No.: NM22L2 Mfg dt: 07/2022 Exp dt: 06/2024 Mfd by: M/s. Acro Lifesciences (India) Pvt. Ltd., C - 86, M.I.D.C., Hingna, Nagpur – 16, Maharashtra. | Description, Particulate Matter & Assay | CDSCO Ahmedabad | CDL Kolkata |
63. | Chlorpheniramine Maleate Tablets I.P. 4 mg | B. No.: 745 Mfg dt: 07/2022 Exp dt: 06/2024 Mfd by: M/s. Deep Pharma, Khedut Sabha Building, Dholka - 382225, Ahmedabad. | Related Substances | CDSCO Ahmedabad | CDL Kolkata |
64. | Ceftal (Ceftriaxone Injection I.P.) | B. No.: UNI-210194 Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. Unital Formulations (A GMP | Particulate Matter, Clarity of Solution & Assay | Drug Control Department Jharkhand | CDL Kolkata |
Certified Company) Plot No. 114-B, EPIP, Phase -1, Jharmajri,, Baddi, Dist. Solan, Himachal Pradesh. | |||||
65. | Ropula Injection-20 ml (Propofol Emulsion for Injection IP 10mg/ml) | B. No.: NADPF1C Mfg dt: 06/2022 Exp dt: 05/2024 Mfd by: M/s. Nixi Laboratories Pvt. Ltd., VPO Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour - 173 030, Himachal Pradesh. | Assay | Drug Control Department Himachal Pradesh | CDL Kolkata |
66. | Propoven Injection-20 ml (Propofol Emulsion for Injection IP 10 mg/ml) | B. No.: NADPF1A Mfg dt: 06/2022 Exp dt: 05/2024 Mfd by: M/s. Nixi Laboratories Pvt. Ltd., VPO Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour - 173 030, Himachal Pradesh. | Assay | Drug Control Department Himachal Pradesh | CDL Kolkata |
67. | Pufolin Injection- 20 ml (Propofol Emulsion for Injection IP 10 mg/ml) | B. No.: NADPF1B Mfg dt: 06/2022 Exp dt: 05/2024 Mfd by: M/s. Nixi Laboratories Pvt. Ltd., VPO Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour - 173 030, Himachal Pradesh. | Assay | Drug Control Department Himachal Pradesh | CDL Kolkata |
68. | Pfolol-10 Injection-10 ml (Propofol Emulsion for Injection IP 10 mg/ml), | B. No.: NADOG1C Mfg dt: 07/2022 Exp dt: 06/2024 Mfd by: M/s. Nixi Laboratories Pvt. Ltd., VPO Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour - 173 030, | Assay | Drug Control Department Himachal Pradesh | CDL Kolkata |
Himachal Pradesh. | |||||
69. | Nenfol Injection-10 ml (Propofol Injection BP 10mg/ml) | B. No.: NADOG1A Mfg dt: 07/2022 Exp dt: 06/2024 Mfd by: M/s. Nixi Laboratories Pvt. Ltd., VPO Mouza Ogli, Sadhaura Road, Kala-Amb, Distt. Sirmour - 173 030, Himachal Pradesh. | Assay | Drug Control Department Himachal Pradesh | CDL Kolkata |
70. | MIDZOCULE 10 Injection (Midazolam Injection I.P. 1mg/ml | B. No.: BLMZ121001 Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s. Safe Parenterals Pvt. Ltd., Gollapadu-522408, Guntur Distt. Andhra Pradesh, India. | pH and Assay | CDSCO South Zone Chennai | CDL Kolkata |
71. | Ciprofloxacin Tablets IP 500 mg | B. No.: CPT22006 Mfg dt: 05/2022 Exp dt: 04/2024 Mfd by: M/s. Vivek Pharmachem (India) Limited, NH-8, Chimanpura, Amer, Jaipur – 303102 Rajasthan. | Dissolution | CDSCO South Zone | CDTL Chennai |
72. | Zinc Sulphate Dispersible Tablets IP 20 mg | B. No.: ZST922 Mfg dt: 02/2022 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. | Assay | CDSCO Subzone Bangalore | CDTL Chennai |
73. | Rabeprazole Sodium Tablets I.P. | B. No.: RBM-501 Mfg dt: 04/2022 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 | Assay | CDSCO Sub- Zone Indore | CDTL Mumbai |
Pradesh. | |||||
74. | Gabapentin Capsules IP 300 mg (GABATIX- 300 CAPSULES) | B. No.: 1721-625 Mfg dt: 11/2021 Exp dt: 10/2024 Mfd by: M/s. ZEE LABORATORIES LTD. Behind 47, Industrial Area, Paonta Sahib-173205 Himachal Pradesh. | Related Substances | CDSCO Sub-Zone Baddi | RDTL Chandigarh |
75. | Ondansetron Tablets IP 4 mg | B. No.: ONTZ-07 Mfg dt: 04/2022 Exp dt: 03/2024 Mfd by: M/s. NESTOR PHARMACEUTICAL S LIMITED, 11, Western Extension Area, Faridabad- 121001, Haryana INDIA. | Assay | CDSCO North Zone | RDTL Chandigarh |
76. | Cefoperazone and Sulbactam For Injection (Suf-DT Injection) | B. No.: SRI22-011R3 Mfg dt: 06/2022 Exp dt: 05/2024 Mfd by: M/s. Subham Remedies, Khasra No-169, Tanshipur, Roorkee, Uttarakhand. | Clarity and Colour of Solution, Water and Assay of Sulbactam sodium | CDSCO North Zone | RDTL Chandigarh |
77. | Ramipril Tablets IP 5.0 mg | B. No.: RMFT905 Mfg dt: 10/2021 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. | Assay of Ramipril | CDSCO North Zone | RDTL Chandigarh |
78. | Tolperisone Hydrochloride Tablets 150 mg | B. No.: TSB-501 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. Healers | Assay | CDSCO North Zone | RDTL Chandigarh |
Lab Unit II, Plot No. 33, H.P.S.I.D.C., Extn.Baddi, Distt- Solan, Himachal Pradesh. | |||||
79. | Clopidogrel Tablets IP 75 mg | B. No.: CPDT21002 Mfg dt: 08/2021 Exp dt: 07/2023 Mfd by: M/s. Ravian Life Sciences Pvt.Ltd., Plot No. 34, Sector-8A, IIE, SIDCUL, Haridwar- 249403, Uttarakhand, INDIA. | Assay | CDSCO North Zone | RDTL Chandigarh |
80. | Propofol Emulsion for Injection IP 10 mg/ml (Propoven Injection) | B. No.: PNL-220513 Mfg dt: 05/2022 Exp dt: 04/2024 Mfd by: M/s. Nixi Laboratories Pvt. Ltd, VPO. MouzaOgli, Sadhaura Road, Kala-Amb, Distt Sirmour-173030 Himachal Pradesh. | Assay | CDSCO Sub-Zone Baddi | RDTL Chandigarh |
81. | Bisacodyl Tablets IP (Dulax Tablets) | B. No.: DT2H005 Mfg dt: 08/2022 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. | Assay | CDSCO North Zone | RDTL Chandigarh |
82. | Bisacodyl Tablets IP 5 mg (Bicolax- 5 Tablets) | B. No.: 12235 Mfg dt: 12/2020 Exp dt: 11/2023 Mfd by: M/s. ELIKEM PHARMACEUTICAL S PVT. LTD., 816/1, Rakanpur, Ta. Kalol, Dist. Gandhinagar, Gujarat. India | Dissolution test (Buffer Stage) and Assay | CDSCO North Zone | RDTL Chandigarh |
83. | Domperidone Tablets IP 10 mg (Domcolic Tablets) | B. No.: GSM0040 Mfg dt: 10/2021 Exp dt: 09/2023 Mfd by: M/s. Skymap Pharmaceuticals Pvt. Ltd., B-3, Dev Bhoomi Industrial Estate Puhana Iqbalpur Road, Roorkee – 247667 Uttarakhand. | Identification | CDSCO North Zone | RDTL Chandigarh |
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