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Date: 2023-07-19 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of June 2023

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 (NSQ), Spurious, Adulterated, or Misbranded for the month of June 2023.
  • Out of 1273 samples tested, 1225 were declared as of Standard Quality, 48 as Not of Standard Quality, 1 as Spurious, and none as Misbranded.

Key Changes

  • 48 samples were declared as Not of Standard Quality due to reasons such as failure in assay, dissolution, related substances, description, identification and disintegration tests.
  • 1 sample of Heparin Inj. I.P. 1000 IU/ml (Batch No. DP2127) manufactured by Divine Laboratories Pvt. Ltd. was declared as Spurious due to failure in Identification and Potency of Heparin.
  • The listed products failed to meet quality standards based on tests conducted by CDSCO (Central Drugs Standard Control Organization) and State Drug Control Departments.
  • The products listed are manufactured by various companies located across India, including Himachal Pradesh, Punjab, Uttarakhand, Maharashtra, Gujarat, Karnataka, Tamil Nadu, West Bengal, Sikkim and others.
  • The reasons for declaring products as NSQ include issues with assay of active ingredients (e.g., Aspirin, Clopidogrel, Ifosfamide, Rosuvastatin, Salmeterol, Fluticasone Propionate, Methylcobalamin), dissolution issues, presence of related substances, incorrect description, disintegration and uniformity of weight.

Impact Analysis

Manufacturers

  • Manufacturers should review their quality control processes, raw material sourcing, and manufacturing practices to ensure compliance with standards.

Distributors/Retailers

  • Implement robust tracking and tracing systems to quickly identify and remove substandard products from the supply chain.

Consumers/Patients

  • Healthcare professionals should be informed about the list of NSQ/Spurious drugs to avoid prescribing them to patients.

Regulatory Authorities (CDSCO/State Drug Control)

  • Enhance collaboration between central and state drug regulatory authorities to improve coordination and information sharing.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. State Drug Control Departments: State-level regulatory bodies responsible for enforcing drug regulations within their respective states. Salus Pharmaceuticals: Manufacturer of Clorin Capsules (Aspirin & Clopidogrel Capsules), batch SPC221847, which failed assay and dissolution tests. Astrica Healthcare Pvt. Ltd.: Manufacturer of Astrifos 2 gm (Ifosfamide Injection IP with Mesna Injection), batch OL220037A, which failed assay test. Synokem Phramaceuticals Ltd.: Manufacturer of Rosuvastatin & Vitamin D3 Tablets, batch 22S1GTA576, which failed assay test. CMG Biotech Pvt. Ltd.: Manufacturer of CGTROM-1 (Nicoumalone Tablets IP), batch CT22231818 and Manokast 5 (Montelukast Tablets IP), batch CT22230271A, which failed related substances and assay tests respectively. Alves Healthcare Private Limited: Manufacturer of Erythromycin Stearate Tablets IP 250 mg, batch AT22356, which failed dissolution test. Gnosis Pharmaceuticals Pvt. Ltd.: Manufacturer of Keraboost (Tablets of D-Biotin, N-Acetyl L-Cysteine, Vitamins & Minerals), batch GT200998, which failed description and assay of Calcium Pantothenate tests. Stanford Laboratories Private Limited: Manufacturer of NUHENZ (Methylcobalamin, Alpha Lipoic acid, Myo-Inositol, Folic Acid, Chromium Polynicotinate, Selenium Dioxide Monohydrate & Benfotaimine Capsules), batches D222427 and D222376, which failed assay of Alpha Lipoic acid test. Maxheal Pharmaceuticals (India) Ltd.: Manufacturer of Maxflux 100 ml (Flucloxacillin Oral solution BP 125mg/5ml), batches M481001, M481002, M481003 and M481004, which failed assay of Flucloxacillin test. Aan Pharma Private Limited: Manufacturer of Anabol Syrup (Cyproheptadine Hydrochloride Syrup IP), batch L22556, which failed assay of Cyproheptadine Hydrochloride test. Stallion Laboratories Pvt. Ltd.: Manufacturer of Glipizide Tablets I.P. 5 mg, batch T3180, which failed dissolution test. Indiana Ophthalmics LLP: Manufacturer of IO-Pred-S Eye Drops (Prednisolone Acetate Ophthalmic Suspension USP), batches N22L17 and N22L18, which failed assay of Prednisolone Acetate test. Karnataka Antibiotics & Pharmaceuticals Limited: Manufacturer of Ofloxacin and Ornidazole Tablets IP, batch 6001022, which failed description test. Unicure India Ltd.: Manufacturer of Prednisolone Tablets I.P. 5 mg, batch PDT1009 and CLOZAPINE TABLETS I.P. 100 MG, batch CZPT1006, which failed related substances and assay tests respectively. Oxalis Labs: Manufacturer of Flutrol 250 (Salmeterol and Fluticasone Propionate Inhalation I.P.), batch NSB2206A, which failed assay of Salmeterol Xinafoate and Fluticasone Propionate test. Mascot Health Series Pvt. Ltd.: Manufacturer of Aceclofenac Tablets I.P. (100 mg), batch MT224501 and Aluminium Hydroxide (0.291 gm), Magnesium Hydroxide (98 mg) and Oxetacaine (10 mg ) Gel, batch ML220582, which failed dissolution and assay of Oxetacaine tests respectively. Hindustan Antibiotics Ltd.: Manufacturer of Paracetamol Tablets I.P. 650 mg, batch 0019 and CETIRIZINE TABLETS IP 10 mg, batch 0051, which failed dissolution and related substances tests respectively. Apple Formulations Pvt. Ltd.: Manufacturer of Glimkar-4 (Glimepiride Tablets 4 mg), batch GKR-2210, which failed dissolution test. Macleods Pharmaceuticals Ltd.: Manufacturer of Acenomac 1 (Nicoumalone Tablets IP), batch FNU02202A, which failed related substances test. Saar Biotech: Manufacturer of Mupirocin Ointment IP 2% w/w, batch 002, which failed assay test. Divine Laboratories Pvt. Ltd.: Manufacturer of FLAGORIN (Heparin Inj. I.P. 1000 IU/ml), batch DP2127, which failed Identification and Potency of Heparin test and deemed to be Spurious. DM PHARMA PRIVATE LIMITED: Manufacturer of Telmisartan Tablets IP 40 mg (TLS-40 TABLETS), batch DT0862B, which failed dissolution test. NESTOR PHARMACEUTICALS LIMITED: Manufacturer of Aciclovir Tablets IP 400 mg, batch YCTZ-01, which failed assay of Aciclovir test. Trugen Pharmaceuticals Pvt. Ltd.: Manufacturer of Telmisartan Tablets IP 40 mg (Telwin-40 Tablets), batch TT230416, which failed dissolution test. LA-CHEMICO PRIVATE LIMITED: Manufacturer of Zinc Sulphate Dispersible Tablets IP, batch ZST22015, which failed disintegration test. ZEE LABORATORIES LTD.: Manufacturer of Acetazolamide Tablets IP 250 mg, batch 423-27, which failed uniformity of weight test. Cooper Pharma Ltd.: Manufacturer of NOOPHIN (BUPRENORPHIN E INJECTION I.P. 2ml), batch LM18920, which failed Related substances test. BITECH LABORATORY: Manufacturer of Diclofenac Sodium Injection IP INDORE-452015 (M.P.) DOLOMAX 25mg/ml, batch FDF1-098, which failed Assay test. CADILA PHARMACEUTICALS LIMITED: Manufacturer of RANITIDINE TABLETS IP 150mg (ACILOC 150), batch LD21512, which failed Description test. Wings biotech LLP: Manufacturer of Chlorpheniramine Maleate & Codeine Phosphate Syrup ONEREX™ COUGH SYRUP, batch ONCS 1713, which failed Identification and Assay of Codeine phosphate test. ALKEM HEALTH SCIENCE: Manufacturer of Pantoprazole Gastro- Resistant Tablets IP (PAN*40), batches 22440483 and 22441073, which failed Assay of Pantoprazole test. Phytochem Healthcare: Manufacturer of Panqub™ DSR Capsules (Pantoprazole Sodium (GR) & Domperidone (PR) Capsules I.P.), batch PHC-21252, which failed Dissolution of Domperidone test. Anant Pharmaceuticals: Manufacturer of Ceeti-LM (Levocetirizine & Montelukast Sodium Tablets I.P.), batch ALT-0432, which failed Dissolution of Montelukast and Levocetirizine Hydrochloride test. ADROIT PHARMACEUTICALS Pvt. Ltd: Manufacturer of DICLOFENAC SODIUM TABLETS I.P.50 mg, batch TS7464, which failed Test for Disintegration (Acid Stage) test. HIPPO LABS PVT. LTD: Manufacturer of ALUMINIUM HYDROXIDE ,MAGNESIUM HYDROXIDE & ACTIVATED DIMETHICONE SUSPENSION (HICID-MPS SUSPENSION), batch HCD 2201, which failed Weight per ml test. VANCE & HEALTH PHARMACEUTICALS PVT. LTD: Manufacturer of ALBENDAZOLE TABLETS I.P. 400 MG (FOZY), batch RD09-2202, which failed Test for Dissolution test. JPEE DRUGS: Manufacturer of PANTOPRAZOLE GASTRO RESISTANT TABLETS IP 40 MG, batches JDT-7092 and JDT-7132, which failed Test for Dissolution (Buffer Stage) test. HANUCHEM LABORATORIES: Manufacturer of TELMISARTAN TABLETS IP 20 MG (TELTAN 20), batch HCL2317, which failed Test for Dissolution test.
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List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of June– 2023. Total number of samples tested: 1273 Total number of samples declared as of Standard Quality: 1225 Total number of samples declared as Not of Standard Quality: 48 Total number of samples declared as Spurious: 1 Total number of samples declared as Misbranded: NIL S.No Name of Batch No. Date of Date of Manufactured By Reason for Drawn By From Drugs/medical Manufa Expiry failure device/cosmetics cture 1 Clorin Capsules SPC221847 Aug-22 Jul-24 Salus Pharmaceuticals, Assay of Aspirin CDSCO CDL Kolkata (Aspirin & 480/211, Harraipur, P.O. & Dissolution of Hyderabad Clopidogrel Gurumajra, Teh. Baddi, Aspirin Capsules) Dist. Solan (H.P.) – 173205 2 Astrifos 2 gm OL220037A Aug-22 Jul-24 Astrica Healthcare Pvt. Assay of CDSCO CDL Kolkata (Ifosfamide Ltd., First Floor, Plot No. Ifosfamide Hyderabad Injection IP with 9-18/5, Bharathi Nagar, Mesna Injection) Temple Alwal, Medchal Hyderabad - 10, Works At: Vill: Gaunspura, P.O. Noorpur Bet, Hambran, Ludhiana – 141 008 Punjab . 3 Rosuvastatin & 22S1GTA576 May-22 Apr-24 Synokem Phramaceuticals Assay of CDSCO CDL Kolkata Vitamin D3 Tablets Ltd., Plot No. 35-36, Rosuvastatin Bangalore Sector - 6A, I.I.E. (SIDCUL), Ranipur (BHEL), Haridwar - 249 403, (Uttarakhand). Page 1 of 94 CGTROM-1 CT22231818 Mar-23 Feb-25 CMG Biotech Pvt. Ltd., 58, Related CDSCO CDL Kolkata (Nicoumalone Industrial Area, Phase-III, substances Bangalore Tablets IP) Sansarpur Terrace, HP - 176 501. 5 Erythromycin AT22356 Dec-22 Nov-24 Alves Healthcare Private Dissolution CDSCO CDL Kolkata Stearate Tablets IP Limited, Village: Nangal South Zone 250 mg Uperla, Swarghat Road, Chennai Tehsil: Nalagarh, Distt. Solan – 174 101 H.P., India 6 Keraboost (Tablets GT200998 Sep-22 Aug-24 Gnosis Pharmaceuticals Description and CDSCO CDL Kolkata of D-Biotin, N- Pvt. Ltd., Nahan Road, Assay of South Zone Acetyl L-Cysteine, Village: Moginand, Kala Calcium Chennai Vitamins & Amb, Distt. Sirmour , H.P. Pantothenate Minerals) 173030. 7 NUHENZ D222427 Oct-22 Sep-24 Stanford Laboratories Assay of Alpha CDSCO CDL Kolkata (Methylcobalamin, Private Limited, 8, Lipoic acid South Zone Alpha Lipoic acid, Industrial Area, Mehatpur, Chennai Myo-Inositol, Folic Distt. Una, (H.P.) – 174 Acid, Chromium 315, India Polynicotinate, Selenium Dioxide Monohydrate & Benfotaimine Capsules) 8 NUHENZ D222376 Aug-22 Jul-24 Stanford Laboratories Assay of Alpha CDSCO CDL Kolkata (Methylcobalamin, Private Limited, 8, Lipoic acid South Zone Alpha Lipoic acid, Industrial Area, Mehatpur, Chennai Myo-Inositol, Folic Distt. Una, (H.P.) – 174 Acid, Chromium 315, India Polynicotinate, Selenium Dioxide Monohydrate & Benfotaimine Capsules) Page 2 of 99 Maxflux 100 ml M481001 Jul-21 Jun-23 Maxheal Pharmaceuticals Assay of CDSCO CDL Kolkata (Flucloxacillin Oral (India) Ltd., 95/6, M.I.D.C. Flucloxacillin West Zone solution BP Satpur, Nashik, Mumbai 125mg/5ml Maharashtra 422 007. 10 Maxflux 100 ml M481002 Jul-21 Jun-23 Maxheal Pharmaceuticals Assay of CDSCO CDL Kolkata (Flucloxacillin Oral (India) Ltd., 95/6, M.I.D.C. Flucloxacillin West Zone solution BP Satpur, Nashik, Mumbai 125mg/5ml Maharashtra 422 007. 11 Maxflux 100 ml M481003 Jul-21 Jun-23 Maxheal Pharmaceuticals Assay of CDSCO CDL Kolkata (Flucloxacillin Oral (India) Ltd., 95/6, M.I.D.C. Flucloxacillin West Zone solution BP Satpur, Nashik, Mumbai 125mg/5ml Maharashtra 422 007. 12 Maxflux 100 ml M481004 Jul-21 Jun-23 Maxheal Pharmaceuticals Assay of CDSCO CDL Kolkata (Flucloxacillin Oral (India) Ltd., 95/6, M.I.D.C. Flucloxacillin West Zone solution BP Satpur, Nashik, Mumbai 125mg/5ml Maharashtra 422 007. 13 Anabol Syrup L22556 Mar-23 Feb-25 Aan Pharma Private Assay of CDSCO CDL Kolkata (Cyproheptadine Limited, 816/1, Rakanpur, Cyproheptadine Ahmedabad Hydrochloride Ta. Kalol Dist. Hydrochloride Syrup IP) Gandhinagar – 380 060, Gujarat (India). 14 Glipizide Tablets T3180 Mar-23 Feb-25 Stallion Laboratories Pvt. Dissolution CDSCO CDL Kolkata I.P. 5 mg Ltd., C-1B, 305/2, 3, 4 & 5, Ahmedabad G.I.D.C. Kerala (Bavla), Dist. Ahmedabad - 382220, Gujarat, India Page 3 of 915 IO-Pred-S Eye N22L17 Dec-22 Nov-24 Indiana Ophthalmics LLP, Assay of CDSCO CDL Kolkata Drops 135,136,137, G.I.D.C. Prednisolone Ahmedabad (Prednisolone Estate, Phase-II, Acetate Acetate Wadhwan City - 363035, Ophthalmic Dist. Surendranagar, Suspension USP) Gujarat, India 16 IO-Pred-S Eye N22L18 Dec-22 Nov-24 Indiana Ophthalmics LLP, Assay of CDSCO CDL Kolkata Drops 135,136,137, G.I.D.C. Prednisolone Ahmedabad (Prednisolone Estate, Phase-II, Acetate Acetate Wadhwan City - 363035, Ophthalmic Dist. Surendranagar, Suspension USP) Gujarat, India 17 Manokast 5 CT22230271A May-22 Apr-24 CMG Biotech Pvt. Ltd., Assay of CDSCO C DL Kolkata (Montelukast 58, Industrial Area, Phase- Montelukast East Zone Tablets IP) III, Sansarpur Terrace – Kolkata 176501 (H.P.). 18 Ofloxacin and 6001022 Jun-22 May-25 Karnataka Antibiotics & Description CDSCO C DL Kolkata Ornidazole Tablets Pharmaceuticals Limited, East Zone IP Plot No.14, II Phase Kolkata Peenya, Bengaluru – 560 058 19 Prednisolone PDT1009 Oct-22 Sep-24 Unicure India Ltd., C-21, Related CDSCO C DL Kolkata Tablets I.P. 5 mg 22 & 23, Sector -3 Noida Substances East Zone 201301, Distt. Gautam Kolkata Budha Nagar (U.P.) 20 Flutrol 250 NSB2206A Apr-22 Mar-25 Oxalis Labs, Village: Assay of CDSCO C DL Kolkata (Salmeterol and Theda, P.O. Lodhimajra, Salmeterol East Zone Fluticasone Tehsil: Baddi Distt. Solan, Xinafoate and Kolkata Propionate Himachal Pradesh - Fluticasone Inhalation I.P.) 174101 Propionate 21 Aceclofenac MT224501 Oct-22 Sep-24 Mascot Health Series Pvt. Dissolution CDSCO C DL Kolkata Tablets I.P. (100 Ltd., Plot No. 79, 80, East Zone mg) Sector-6A, IIE, Sidcul, Kolkata Haridwar- 249 403, Uttarakhand. Page 4 of 922 Paracetamol 0019 Jan-23 Dec-24 Hindustan Antibiotics Ltd., Dissolution CDSCO C DL Kolkata Tablets I.P. 650 mg Pimpri, Pune - 411 018, East Zone India Kolkata 23 Glimkar-4 GKR-2210 Apr-22 Mar-24 Apple Formulations Pvt. Dissolution CDSCO C DL Kolkata (Glimepiride Ltd., Plot No. 208, East Zone Tablets 4 mg) Kishanpur, Roorkee – 247 Kolkata 667 (U.K.). 24 Acenomac 1 FNU02202A Nov-22 Oct-24 Macleods Related CDSCO C DL Kolkata (Nicoumalone Pharmaceuticals Ltd., Plot substances East Zone Tablets IP) No. 1, 2 & 3, Mahim Road, Kolkata Near Kuldeep Nagar, Palghar (W) – 401 404, Dist. Thane, Maharashtra. 25 Mupirocin Ointment 002 Mar-22 Feb-24 Saar Biotech, NH-21 A, Assay CDSCO C DL Kolkata IP 2% w/w Bhud, Baddi, Distt. Solan East Zone (HP) - 173205. Kolkata 26 FLAGORIN DP2127 Jul-22 Jun-25 Divine Laboratories Pvt. Identification (A) CDSCO C DL Kolkata (Heparin Inj. I.P. Ltd., Block No. 471, and Potency of East Zone 1000 IU/ml) Dabhasan, Tal - Padra, Heparin The Kolkata Distt. Vadodara – 391 440, sample is India. deemed to be Spurious 27 Telmisartan DT0862B Jul-22 Jun-24 DM PHARMA PRIVATE Dissolution CDSCO RDTL Tablets IP 40 mg LIMITED, Vill. Bhud, NH- SubZone Chandigarh (TLS-40 TABLETS) 21A, Baddi, Distt. Solan Bangalore (H.P.)-173205. 28 Aciclovir Tablets IP YCTZ-01 Jun-22 May-24 NESTOR Assay of CDSCO RDTL 400 mg PHARMACEUTICALS Aciclovir North Zone Chandigarh LIMITED, 11, Western Ghaziabad Extension Area, Faridabad-121001, INDIA Page 5 of 929 Telmisartan TT230416 Mar-23 Feb-25 Trugen Pharmaceuticals Dissolution CDSCO RDTL Tablets IP 40 mg Pvt. Ltd., Vill. Tejjupur, North Zone Chandigarh (Telwin-40 Tablets) Near Chodiala Rly. Ghaziabad Station, Roorkee, Distt. Haridwar, Uttarakhand- 247661 30 Zinc Sulphate ZST22015 Feb-22 Jan-24 LA-CHEMICO PRIVATE Disintegration CDSCO RDTL Dispersible Tablets LIMITED, Taki Road, Test North Zone Chandigarh IP Kadambagachi, Barasat, Ghaziabad North 24-Paraganas, Kolkata-700125, W.B. 31 Aluminium ML220582 Oct-22 Sep-24 Mascot Health Series Pvt. Assay of CDSCO RDTL Hydroxide (0.291 Ltd., Plot No. 79, 80, Oxetacaine North Zone Chandigarh gm), Magnesium Sector-6A, IIE, Sidcul, Ghaziabad Hydroxide (98 mg) Haridwar-249403 and Oxetacaine (10 mg ) Gel 32 Acetazolamide 423-27 Jan-23 Dec-25 ZEE LABORATORIES Uniformity of CDSCO RDTL Tablets IP 250 mg LTD., Behind 47, Industrial weight North Zone Chandigarh Area, Paonta Sahib- Ghaziabad 173025 33 CETIRIZINE 0051 May-22 Apr-24 Hindustan Antibiotics Ltd., Related CDSCO CDTL TABLETS IP 10 (A Govt. Of India substances West Zone Mumbai mg Enterpriese), Pimpri, Pune Mumbai - 411018. 34 NOOPHIN LM18920 Aug-21 Jul-27 Cooper Pharma Ltd.C3 Related Drug Control RDTL (BUPRENORPHIN Industrial area Substances Department Guwahati E INJECTION I.P. Selaque,Dehradun – Bihar 2ml) 248197 35 Diclofenac Sodium FDF1-098 Sep-21 Aug-23 BITECH LABORATORY Assay Drug RDTL Injection IP INDORE-452015 (M.P.) Controller Guwahati DOLOMAX Department 25mg/ml Gaya Page 6 of 936 RANITIDINE LD21512 OCT.20 MAR.2 CADILA Description Drug RDTL TABLETS IP 21 024 PHARMACEUTICALS Controller Guwahati 150mg LIMITED, Department (ACILOC 150) 1389, DHOLKA – 382225, Sikkim Dist.: Ahmedabad 37 Chlorpheniramine ONCS 1713 MAR.2 FEB.20 Wings biotech LLP Identification Drug RDTL Maleate & Codeine 022 24 43 & 44, HPSIDC and Assay of Controller Guwahati Phosphate Syrup Industrial Area, Codeine Department ONEREX™ Baddi- 17205 (H.P.) phosphate Bihar COUGH SYRUP 38 Pantoprazole 22440483 Feb-22 Jul-24 ALKEM HEALTH Assay of Drug RDTL Gastro- Resistant SCIENCE, Pantoprazole Controller Guwahati Tablets IP A unit of Alkem Department (PAN*40) Laboratories Limited, Unit- Bhagalpur 2, Samardung Karek Block, P.O.: Namthang, South Sikkim- 737137 39 Panqub™ DSR PHC-21252 Jan-22 Dec-23 Phytochem Healthcare, Dissolution of Drug RDTL Capsules Vill- Theda, Lodhimajra Domperidone Controller Guwahati (Pantoprazole Road, PO- Manpura, Department Sodium (GR) & Kharuni, The- Nalagarh, Assam Domperidone (PR) Dist. Solan (H.P.) - Capsules I.P.) 174101 40 PAN 40 22441073 Apr-22 Sep-24 ALKEM HEALTH Assay of Drug RDTL (Pantoprazole SCIENCE, Pantoprazole Controller Guwahati Gastro- Resistant A unit of Alkem Depertment Tablets I.P.) Laboratories Limited, Unit- Goalpara 2, Samardung Karek Block, P.O.: Namthang, South Sikkim- 737137 Page 7 of 941 Ceeti-LM ALT-0432 Dec-22 Nov-24 Anant Pharmaceuticals Dissolution of Drug RDTL (Levocetirizine & G.T. Road, Uchani, Karnal Montelukast and Controller Guwahati Montelukast - 132001 Levocetirizine Depertment Sodium Tablets Hydrochloride Mizoram I.P.) 42 DICLOFENAC TS7464 Nov-22 Oct-24 ADROIT Test for CDSCO Zonal CDTL SODIUM PHARMACEUTICALS Pvt. Disintegration office Hyderabad TABLETS I.P.50 Ltd at: 46 , Garoba (Acid Stage) Hyderabad mg Maidan, Nagpur -8 (M.S) 43 ALUMINIUM HCD 2201 Feb-22 Jan-24 HIPPO LABS PVT. LTD. Weight per ml CDSCO CDTL HYDROXIDE Plot no. 17 ,R.G. Nagar, Visakhapatna Hyderabad ,MAGNESIUM IDA, Prashanthi Nagar, m HYDROXIDE & Kukatpally,Hyderabad-72 ACTIVATED DIMETHICONE SUSPENSION (HICID-MPS SUSPENSION) 44 CLOZAPINE CZPT1006 Nov-22 Apr-24 UNICURE INDIA LTD, C- Assay CDSCO Zonal CDTL TABLETS I.P. 100 21, 22 &23 Sector-3, office Hyderabad MG Noida -201301, Distt. Hyderabad Gautam Budh Nagar (U.P.) 45 ALBENDAZOLE RD09-2202 Oct-22 Sep-24 VANCE & HEALTH Test for CDSCO CDTL TABLETS I.P. 400 PHARMACEUTICALS Dissolution Visakhapatna Hyderabad MG (FOZY) PVT. LTD, KHASRA m No.410 Karondi, Roorkee- 247667, Uttarakhand. 46 PANTOPRAZOLE JDT-7092 Feb-23 Jan-25 JPEE DRUGS, Plot no. - Test for CDSCO Zonal CDTL GASTRO 53, Sector 6-A,SIDCUL Dissolution office Hyderabad RESISTANT Haridwar (Uttarakhand). (Buffer Stage) Hyderabad TABLETS IP 40 MG Page 8 of 947 TELMISARTAN HCL2317 Nov-22 Oct-24 HANUCHEM Test for CDSCO Zonal CDTL TABLETS IP 20 LABORATORIES, Plot no. Dissolution office Hyderabad MG (TELTAN 20) 16-17 , Sector-5, Indl. Hyderabad Area , Parwanoo, Dist. Solan -173 220 (H.P.) 48 PANTOPRAZOLE JDT-7132 Feb-23 Jan-25 JPEE DRUGS, Plot no. - Test for CDSCO Zonal CDTL GASTRO 53, Sector 6-A,SIDCUL Dissolution office Hyderabad RESISTANT Haridwar (Uttarakhand). (Buffer Stage) Hyderabad TABLETS IP 40 MG Page 9 of 9

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