Home India Ministry of Health and Family Welfare Drug Alert for the Month of November 2023...
Date: 2023-12-20 Category: Not Applicable State: Union Government Country: India

Drug Alert for the Month of November 2023

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

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Executive Summary & Key Takeaways

What it means

  • This gazette notification lists drugs, medical devices, vaccines, and cosmetics that have been declared as Not of Standard Quality (NSQ), Spurious, Adulterated, or Misbranded for the month of November 2023 following sample testing.
  • A total of 1197 samples were tested, with 62 declared as Not of Standard Quality, 1 as Spurious, and 1 as Misbranded.

Key Changes

  • Out of 1197 samples tested, 1133 samples were declared as Standard Quality.
  • 62 samples of drugs/medical devices/cosmetics were declared as Not of Standard Quality due to reasons such as failure in disintegration test, dissolution, particulate matter, identification and acidity, assay of benzoic acid, clarity of solution, bacterial endotoxins, sterility, and water content.
  • 1 sample was declared as Spurious due to failing the identification test for caffeine.
  • 1 sample was declared as Misbranded with respect to label.
  • The list includes the name of the drug/medical device/cosmetic, batch number, date of manufacture, date of expiry, reason for failure, name of the manufacturer, and the name of the laboratory that conducted the test.

Impact Analysis

Manufacturers

  • Action Item: Review manufacturing processes and quality control procedures to identify and rectify the root causes of substandard products. Implement corrective and preventive actions (CAPA) to avoid future occurrences.

Consumers

  • Action Item: Raise awareness among consumers about the listed products and encourage them to report any adverse events. Strengthen post-market surveillance to detect and address substandard products.

Regulatory Authorities (State Drug Control Departments & CDSCO)

  • Action Item: Conduct thorough investigations of the listed manufacturers and take appropriate legal action. Strengthen collaboration between central and state drug control authorities to improve surveillance and enforcement.

Laboratories (RDTL, CDL)

  • Action Item: Ensure adequate resources and training for laboratory personnel to maintain high standards of testing. Implement quality control measures to ensure the accuracy and reliability of test results.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organisation, the national regulatory body for pharmaceuticals and medical devices in India. RDTL: Regional Drugs Testing Laboratory, a network of laboratories responsible for testing and analyzing drug samples. CDL: Central Drugs Laboratory, the national laboratory for quality control of drugs and pharmaceuticals in India. Drugs and Cosmetics Act, 1940: The primary legislation governing the quality, safety, and efficacy of drugs and cosmetics in India (Implied). State Drug Control Departments: State-level regulatory bodies responsible for licensing, inspection, and enforcement of drug regulations within their respective states.
Official Source Record View Original Source →
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List of Drugs, Medical Devices, Vaccine and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of November- 2023. Total number of samples tested - 1197 Total number of samples declared as Standard Quality - 1133 Total number of samples declared as Not of Standard Quality - 62 Total number of samples declared as Spurious - 01 Total number of samples declared as Misbranded - 01 S. No Name of Batch No. Date of Date of Manufactured Reason for failure Drawn By (From From (Name of Drugs/medical Manufacture Expiry By state/CDSCO Laboratory) device/cosmetics Zone) 1 Bonsai Pharma, Cefixime, Kishanpura, Azithromycin and Drug Control Baddi-Nalagarh RDTL, Lactic Acid Bacillus JUN-23102 Jun-2023 May-2025 Disintegration test Department Road, Chandigarh Tablets (SEFIX-CZ LB Himachal Pradesh P.O.Gurumajara, TABLETS) Distt. Solan (H.P.) 2 Healers Lab, Unit II, Plot No. 33, Paracetamol Tablets IP RDTL, PRS-520 Aug-2022 Jul-2025 H.P.S.I.D.C., Dissolution CDSCO Baddi 500 mg Chandigarh Extn., Baddi, Distt. Solan (H.P.) 3 E.G. Pharmaceuticals, Ondansetron Injection RDTL, ION-10869 Jun-2023 May-2025 Vill. Mandhala, Particulate Matter CDSCO Baddi IP (Ondacip Injection ) Chandigarh Teh.Baddi, Distt. Solan (H.P.) 4 Pharm Asia Durg, 20-21, Panchal Compound, Hydrogen Peroxide Survey no : 78/1, Identification and CDSCO North Zone RDTL, Topical Solution IP 6% HP22-021 Feb-2022 Jan-2024 PH no: 17, New Acidity Ghaziabad Chandigarh w/v 45, Gram Lasudia Mori, Indore- 452010 (M.P.) Page 1 of 145 MAXTAR BIO- GENICS, Khasra No. 705, Vill. Drug Control Malku Majra, RDTL, Albendazole Tablets IP MS1AO2205 Oct-2022 Sep-2025 Dissolution test Department Nalagarh Road, Chandigarh Himachal Pradesh Baddi, Distt. Solan-173205 (H.P.)-India 6 S.K. Picglobal Co.Ltd., 255, Propylene Glycol USP Youngjam-ro, Water CDSCO North Zone F10121UP Nov-2022 Nov-2024 CDL, Kolkata (PGUSP) Nam-gu, Ulsan, Determination Ghaziabad South Korea 680130. 7 Konis CDSCO, Sub- Methylcobalamin Pharmaceuticals, Particulate Matter MC-2307 Aug-2023 Jan-2025 Zone CDL, Kolkata Injection 1 ml Krishna Nagar - & Description Visakhapatnam 522 502 (A.P.). 8 Yeluri Formulations Pvt Ceftriaxone For Ltd., Sy. No. Constituted CDSCO, Injection USP (SHANU- YSF3103 Aug-2023 Jul-2026 296/7/6, IDA Solution & CDL, Kolkata Hyderabad CEFT 2 GM) Bollaram, Medak Particulate Matter District-502325, Telangana, India. 9 Biozenta Lifesciences Pvt. DOXORUBICIN Ltd., Khasra No. Related HYDROCHLORIDE FOR OL23085 Jun-2023 May-2025 59, 60 & 61, Bela Substances & CDSCO Hyderabad CDL, Kolkata INJECTION BP 10 MG Bathri, Haroli, water (DOXOTERO - 10) Una, Himachal Pradesh - 174301 Page 2 of 1410 Bless Pharma India Private Limited, H. No. 3- 90/1/1, D. Pochampally Palonosetron Injection Village, Dundigal, Bacterial 0.25 mg / 5 ml PSI230501 May-2023 Apr-2025 CDSCO Hyderabad CDL, Kolkata Gandimaisamma endotoxins (Palonolive) Mandal, Medchal- Malkajgiri Dist, Telangana- 500043 11 Bless Pharma India Private Limited, H. No. 3- 90/1/1, D. Granisetron Pochampally Hydrochloride Village, Dundigal, CDSCO, GSI230101 Jan-2023 Dec-2024 Test for ‘pH' CDL, Kolkata Injection 3mg / 3ml Gandimaisamma Hyderabad (EMYTRON) Mandal, Medchal- Malkajgiri Dist, Telangana- 500043 12 Aristo Pharmaceuticals Pvt. Ltd., Plot No. 208, New Ceftraixone Injection CDSCO, MPD231319 Apr-2023 Sep-2025 Industrial Area Clarity of solution CDL, Kolkata IP (Monocef 500 mg) Hyderabad No. 2, Mandideep - 462046, Dist. Raisen (M.P.) Page 3 of 1413 Vivek Compound Benzoic Pharmachem CDSCO Assay of Benzoic Acid Ointment IP - 15g B21027 Dec-2021 Nov-2023 (India) Ltd., EPIP, South Zone CDL, Kolkata Acid (Whitfield's Ointment) Bari Brahmana, Chennai Jammu - 181133. 14 Vivek Pharmachem CDSCO Ceftriaxone Injection (India) Ltd., NH-8, CFI23016 Feb-23 Jan-25 Clarity of solution South Zone CDL, Kolkata IP 1g Chimanpura, Chennai Amer, Jaipur - 303 102. 15 Rabeprazole Sodium Talwar Pharma, (Enteric Coated) & Jhabrera Road, CDSCO, Domperidone Kurdi, Manglour RPC-230704 Jul-2023 Jun-2025 Dissolution Sub-Zone CDL, Kolkata (Sustained Release) 247656, Roorkee, Rishikesh Capsules (Rabetal- Distt- Haridwar, DSR) Uttarakhand. 16 Vilin Bio Med Ltd., Unit-II, Aceclofenac, Khasra No. 85, Paracetamol & Description & Madhopur, CDSCO Sub-Zone Serratiopeptidase T-231023 Oct-2023 Sep-2025 Assay of CDL, Kolkata Hazarathpur, Rishikesh Tablets (ACLOWIN- Serratiopeptidase Roorkee - PLUS) 247667, Uttarakhand. 17 Vilin Bio Med Ltd., Unit-II, Khasra No. 85, Gabapentin & Assay of Madhopur, CDSCO Sub- Amitriptyline HCl T-230420 Apr-2023 Mar-2025 Amitriptyline CDL, Kolkata Hazarathpur, Zone Rishikesh Tablets (GABAMER AT) Hydrochloride Roorkee - 247667, Uttarakhand. Page 4 of 1418 Vilin Bio Med Ltd., Unit-II, Khasra No. 85, Description, Ferrous Ascorbate & L- CDSCO, Madhopur, Disintegration & Methylfolate Tablets T-230861 08/2023 07/2025 Sub-Zone CDL, Kolkata Hazarathpur, Assay of L- (Bravofer) Rishikesh Roorkee - Methylfolate 247667, Uttarakhand. 19 Manali Petrochemicals CDSCO, PG-IP/2023- Limited, Plant-II, Propylene Glycol IP 08/2023 07/2028 Water Sub-Zone CDL, Kolkata 24/2233 Sathangadu Rishikesh Village, Manali, Chennai - 600068 20 CHLORPHENAMINE Daffohils MALEATE, Laboratories Pvt. PHENYLEPHRINE Ltd., F-109-110, Assay/Content of CDSCO, HYDROCHLORIDE & UPSIDC, DLS-2540 07/2023 06/2025 Chlorphenamine Sub-Zone CDL, Kolkata DEXTROMETHORPHAN Industrial Area, Maleate Rishikesh HYDROBROMIDE Selaqui, SYRUP (KASJEL-CP Dehradun, U.K.- SYRUP) 248011 (India) 21 Manali Petrochemicals CDSCO, PG-IP/2022- Limited, Plant-II, PROPYLENE GLYCOL IP 03/2023 02/2028 Water content Sub-Zone CDL, Kolkata 23/2512 Sathangadu Rishikesh Village, Manali, Chennai - 600068 22 Manali Petrochemicals CDSCO, PG-IP/2023- Limited, Plant-II, Propylene Glycol IP 08/2023 07/2028 Water content Sub-Zone CDL, Kolkata 24/2206 Sathangadu Rishikesh Village, Manali, Chennai - 600068 Page 5 of 1423 Cotec Healthcare Pvt. Ltd., NH No. 74, Roorkee Assay & Related CDSCO, GLICLAZIDE TABLETS Dehradun CHT-3850 08/2023 07/2025 substances of Sub-Zone CDL, Kolkata IP 40 mg Highway, Gliciazide Rishikesh Kishanpur, Roorkee-247667 Uttarakhand. 24 Goya Agro CDSCO, Sorbitol Solution IP GAIL-IP-505 Jun-2023 Jun-2028 Industries Pvt. Test for ‘Water’ Sub-Zone CDL, Kolkata (70%) Ltd. Rishikesh 25 Manali PG-IP/2023- CDSCO Sub-Zone Propylene Glycol IP Jul-2023 Jun-2028 Petrochemicals Water content CDL, Kolkata 24/2158 Rishikesh Limited. 26 Kanha Biogenetic, Plot Unlabeled white No. 1B, EPIP, Not tablets Calcium and Unlabeled Not mentioned Phase 1, Description CDSCO Baddi CDL, Kolkata mentioned Vitamin D3 Jharmajri, Baddi, Dist. Solan, (H.P.). 27 Description, Maya Biotech Particulate Matter Pvt. Ltd., Khasra DOBUTAMINE in injection, No. 515/3, INJECTABLE USP ALY038 Jun-2022 May-2024 Container content CDSCO Baddi CDL, Kolkata Village Kondi, 12.5mg / ml and Assay of P.O. Thana, Baddi Dobutamine (H.P.) Hydrochloride 28 Affy Parenterals, Unlabeled vials with at Village Red seal purported to Not Misbranded with Unlabeled Not mentioned Gullarwala, Sai CDSCO Baddi CDL, Kolkata contains Pantoprazole mentioned respect to label Road, Baddi, 40 mg Distt. Solan (H.P.) Page 6 of 1429 Unlabeled unpacked Affy Parenterals, Assay of soft gelatin capsules at Village Calcitriol, Calcium purported to contain Not Unlabeled Not mentioned Gullarwala, Sai Carbonate and CDSCO Baddi CDL, Kolkata Calcitriol 0.25 mcg, mentioned Road, Baddi, Zinc Sulphate Calcium 200 mg, Zinc Distt. Solan (H.P.) Monohydrate 7.5mg 30 Jackson Laboratories Pvt. Bacterial Ltd., 22-23, Endotoxin Test, ARTESUNATE I-1219 Jul-2023 Jun-2025 Majitha Road, Particulate Matter CDSCO Baddi CDL, Kolkata INJECTION IP (ZYNATE) Bye Pass, & Clarity of Amritsar- 143001 solution (India) 31 Naprod Life Sciences Pvt. Methotrexate Ltd., Plot No. G- Sterility & Bacterial Injection IP 25 mg / ml NN3188A Apr-2023 Mar-2025 17/1, M.I.D.C. CDSCO Baddi CDL, Kolkata Endotoxin Test (MEREX 1000) Tarapur, Boisar, Dist. Thane - 401506 32 Mascot Health Assay of total gram Series Private positive Limited, Plot No. rod shaped Prebiotic & Probiotic CDSCO East Zone MC230548 Jul-2023 Dec-2024 79, 80, Sec-6A, bacterium CDL, Kolkata Capsules (Floroquik) Kolkata IIE, SIDCUL, proposed to be Haridwar- total lactobacillus 249403 species 33 Unicure India Ltd., C-21, 22 & Montelukast Sodium 23, Sector-3, and Levocetirizine CDSCO East Zone MLCT1026 Feb-2023 Jan-2025 Noida- 201301, Dissolution CDL, Kolkata Hydrochloride Tablets Kolkata Distt. Gautam I.P. Budh Nagar (U.P.). Page 7 of 1434 Salus Pharmaceuticals, 480/211, SPIRONOLACTONE Harraiur, P.O. CDSCO East Zone TABLETS IP SPT221635 Jul-2022 Jun-2024 Dissolution CDL, Kolkata Gurumajra, Teh. Kolkata (SPIRNORAV-100) Baddi, Dist. Solan, (H.P.) - 173205 35 Mascot Health Diphenhydramine Series Private Hydrochloride, Limited, Plot No. Assay/content of CDSCO East Zone Ammonium Chloride, ML220730 Dec-2022 Nov-2024 79, 80, Sec-6A, CDL, Kolkata Menthol Kolkata Sodium Citrate & IIE, SIDCUL, Menthol Syrup Haridwar- 249403 36 Lupin Ltd., A- 28/1, MIDC, RIFAMPICIN CAPSULES CDSCO East Zone A306177 Jan-2023 Dec-2024 Chikalthana, Dissolution CDL, Kolkata IP (R-Cin 150) Kolkata Aurangabad 431210 India. 37 Elegant Cosmed Pvt. Ltd., Plot No. Benzoyl Peroxide 2.5% CDSCO East Zone M032 Aug-2022 Jul-2024 32 & 33, GIDC, Assay CDL, Kolkata w/w Gel (Perolite) Kolkata Kuvadava- 360023, Gujarat. 38 USV Private Limited, Plot No.6 & 7E, Fenofibrate Capsules CDSCO East Zone 28022587 Nov-2021 Oct-2023 HPSIDC Indl. Dissolution CDL, Kolkata IP 200 mg (LIPICARD) Kolkata Area, Baddi, Dist. Solan, Himachal Pradesh 173205. 39 Paracetamol & Baroque Uniformity of Tramadol Pharmaceuticals Dispersion & Assay CDSCO, G012221 Aug-2022 Jul-2025 CDL, Kolkata Hydrochloride Tablets Pvt. Ltd., of Tramadol Ahmedabad (PAAR-TM) Sokhada- Hydrochloride Page 8 of 14388620, Ta. - Khambhat, Dist. Anand, Gujarat, India. 40 Baroque DEXTROMETHORPHAN Pharmaceuticals HYDROBROMIDE, Pvt. Ltd., Assay of PHENYLEPHRINE Sokhada- CDSCO, G013207 Jul-2023 Jun-2025 Phenylephrine CDL, Kolkata HYDROCHLORIDE & 388620, Ta. - Ahmedabad Hydrochloride CHLORPHENIRAMINE Khambhat, Dist. MALEATE SYRUP Anand, Gujarat, India. 41 KamlaAmrut Pharmaceutical LLP, Survey No.: 53, 56, 57 At.: Sodium Chloride Assay of Sodium CDSCO, K4020007 Aug-2023 Jul-2026 Village: Indrad, CDL, Kolkata Injection IP (0.9% w/v) Chloride Ahmedabad Near KamlAmrut Industrial Park, Dist.: Mehsana, Gujarat 42 Bharat Parenterals Ltd., Jarod-Samlaya Meropenem Injection Road, Tal. Savli, Bacterial CDSCO, PI3075 Apr-2023 Mar-2025 CDL, Kolkata IP 0.5 g Vill.: Haripura, Endotoxin Test Ahmedabad Dist. Vadodara- 391520, Gujarat, India 43 Naprod Life Science Pvt. Ltd., Methotrexate Plot No. G-17/1, Sterility & Bacterial CDSCO, Sub-Zone, Injection IP 25 mg / ml NN3139A Mar-2023 Feb-2025 CDL, Kolkata M.I.D.C., Tarapur, endotoxins Varanasi (MEREX 1000) Boisar, Dist. Thane- 401506 Page 9 of 1444 Naprod Life Science Pvt. Ltd., Methotrexate Plot No. G-17/1, CDSCO, Sub-Zone, Injection IP 25 mg / ml NN3188A Apr-2023 Mar-2025 Sterility CDL, Kolkata M.I.D.C., Tarapur, Varanasi (MEREX 1000) Boisar, Dist. Thane- 401506 45 Nest Healthcare Private Limited., Plot No.300. AMLODIPINE TABLETS Related CDSCO South Zone CDTL, NHD22477A Nov-2022 Oct-2024 G.I.D.C., Odhav, IP 5 mg Substances Chennai Hyderabad. Ahmedabad - 382415 (Guj.). India 46 Sunlife Sciences, 130, Kurdi, Jhabrera Road, BISACODYL GASTRO- Manglour, CDTL, RESISTANT TABLETS IP T-230766 Sep-2023 Aug-2025 Dissolution CDSCO, Indore Roorkee, Distt. Hyderabad. 5 mg Haridwar (U.K.) Pin Code : - 247656 47 Senate NIMESULIDE & Laboratories, CDSCO Sub Zone, CDTL, PARACETAMOL ST-908A Jan-2023 Dec-2024 251, 252, Sisona, Disintegration Rishikesh Hyderabad. TABLETS (CABLIDE-P) Roorkee - 247661 (U.K.) 48 Wilcure Remedies PRIVATE LIMITED, PH LEVOFLOXACIN NO.10, Gram CDTL, WT-460 Sep-2023 Aug-2025 Description CDSCO, Indore TABLETS IP 500 mg Mirzapur, Hyderabad. Khandwa Road, Dist. Indore 452020 (MP) India. Page 10 of 1449 Wilcure Remedies PRIVATE LIMITED, PH METRONIDAZOLE NO.10, Gram CDTL, WT-341 Jul-2023 Jun-2025 Dissolution CDSCO, Indore TABLETS IP 200 g Mirzapur, Hyderabad. Khandwa Road, Dist. Indore 452020 (MP) India. 50 Kshipra Drugs Pvt. Ltd., 40- Dexamethasone Drug Control 41/22-B, Description & Tablets IP 0.5 mg. T-22280 Feb-2023 Jan-2025 Department RDTL, Guwahati Industrial Area, Assay (DEXAJOX) Assam No. 1, Dewas (M.P.)- 455001 51 Danish Health Care (P) Ltd., 76/27-28, Drug Control Paracetamol Tablets PDN22024 Jun-2022 May-2024 Industrial Estate, Dissolution Department RDTL, Guwahati I.P. (Paraband-500) Maxi Road, Mizoram Ujjain-456 010, INDIA 52 Nutra Life Healthcare Pvt. Ltd., Plot No. 44- PARACETAMOL AND 45, Shiv Ganga DICLOFENAC SODIUM Dissolution of Industrial Estate, CDSCO sub zone, TABLETS I.P. NLT-108422 Mar-2023 Feb-2025 Paracetamol & RDTL, Guwahati Lakeshwari, Guwahati (DICLOCIN FORTE Diclofenac Sodium Bhagwanpur, TABLETS) Roorkee, Distt. Haridwar, Uttarakhand Page 11 of 1453 Maneesh Pharmaceuticals Doxylamine Succinate, Ltd., Village Pyridoxine Drug Control Balyana, Hydrochloride and DOFM2202 Feb-2022 Jan-2025 Disintegration Department, RDTL, Guwahati Barotiwala, Folic Acid Tablets. Jharkhand Tehsil Kasauli, (Doxinate Forte) Dist. Solan (H.P.) 174103. 54 Cureza Telmisartan Tablets Drug Control Healthcare Pvt. I.P. 40 mg. (Telmisev- CHT22352 Dec-2022 Nov-2024 Dissolution Department RDTL, Guwahati Ltd., A.B. Road, 40) Nagaland Girwai-474001 55 ANG Lifesciences India Ltd., Village Malkumajra, Drug Control CIPROFLOXACIN T032023 Nov-2022 Oct-2024 Nalagarh Road, Dissolution Department RDTL, Guwahati TABLETS I.P. 500 mg. Baddi, Distt. Assam Solan-173205 (H.P.), INDIA 56 Apple Formulations Pvt. Drug Control GLIMEPIRIDE TABLETS Ltd., Plot No.208, GLT-2301 Jan-2023 Dec-2024 Dissolution Department RDTL, Guwahati I.P. 1 mg. Kishanpur, Assam Roorkee-247667 (U.K) 57 HEALTHY LIFE PHARMA PVT. LTD., FACTORY : PYRAZINAMIDE Drug Control N31/1, M.I.D.C., TABLETS I.P. 500 mg 10734 Mar-2023 Aug-2025 Dissolution Department RDTL, Guwahati TARAPUR, (PYRIZ-500) Jharkhand BOISAR, DIST. PALGHAR- 401 506 INDIA. Page 12 of 1458 ANG Lifesciences India Ltd.., Village Drug Control Ciprofloxacin Tablets Malkumajra, T032022 Nov-2022 Oct-2024 Dissolution Department RDTL, Guwahati I.P. 500 mg Nalagarh Road, Assam Baddi, Distt Solan-173205 (H.P.) 59 MODERN LABORATORIES, FRUSEMIDE INJECTION Drug Control 45- 47, Sector D- Sterility & Bacterial IP 10MG/ML. FEI2208 Sep-2022 Aug-2024 Department RDTL, Guwahati 2, Sanwer Road, Endotoxins (FRUSEMIDE) Meghalaya Indore (M.P.) 452 015 INDIA 60 Sangeeta Pharma., A-35, Assay of Nextoux Antiroux M.I.D.C., CDSCO, West- SN3219 May-2023 Apr-2026 Dextromethorphan Expectorant Malegaon, Zone Mumbai Hydrobromide Sinnar- 422103, Dist. Nashik CDTL - Mumbai 61 Astamed Healthcare (I) Pvt. Ltd., Plot No. Paracetamol Tablets 2 & 3, Phase II CDSCO West Zone 3001 Mar-2023 Feb-2025 Dissolution 650 mg (Afebril - 650) Genesis Mumbai Industrial Complex, Kolgaon, Palghar. CDTL - Mumbai 62 Bakul Aromatics and Chemicals Aminophyline Pvt. Ltd., Plot CDSCO West Zone AP/23/0008 Jul-2023 May-2028 Water Anhydrous BP No.A/6, MIDC Mumbai Patalganga, Kaire 410 220 CDTL - Mumbai Page 13 of 1463 Bakul Aromatics and Chemicals Aminophyline Pvt. Ltd., Plot CDSCO West Zone AP/23/0009 Jul-2023 May-2028 Water Anhydrous BP No.A/6, MIDC Mumbai Patalganga, Kaire 410 220 CDTL - Mumbai 64 Bakul Aromatics and Chemicals Spurious with Pvt. Ltd., Plot respect to the CDSCO West Zone Caffeine Anhydrous BP CF/23/0007 Jul-2023 Jun-2028 No.A/6, MIDC Identification test Mumbai Patalganga, Kaire for caffeine 410 220 CDTL - Mumbai Page 14 of 14

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