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Date: 2020-01-22 Category: Not Applicable State: Union Government Country: India

Notice regarding List of Reference Products for conduct of BE Study

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 issued by DCG(I) (Drugs Controller General of India) and CDSCO (Central Drugs Standard Control Organization) provides a list of products permitted and considered as Reference Products for Bioavailability (BA) and Bioequivalence (BE) studies.
  • The list specifies the drug name, its strength, the manufacturer of the reference product, and the drug's Biopharmaceutics Classification System (BCS) class (II or IV).

Key Changes

  • The notification lists 139 drugs along with their respective manufacturers and BCS classification.
  • The drugs are categorized based on their BCS class, either Class II (low solubility, high permeability) or Class IV (low solubility, low permeability).
  • For each drug, the notification specifies the reference product, its manufacturer, and the available strengths.
  • Multiple manufacturers and brands are listed for some drugs, indicating various reference products available in the market.
  • The notification includes the name of the drug, company name/trade name and the product name/manufacturer.

Impact Analysis

Pharmaceutical Manufacturers

  • Action Items: Review the list to identify suitable reference products for their generic formulations. Update regulatory strategies based on the listed reference products.

Regulatory Agencies (CDSCO)

  • Action Items: Utilize the list to ensure consistency in BA/BE study requirements and evaluations.

Research Organizations/CROs

  • Action Items: Align study protocols with the specified reference products to ensure regulatory compliance.

Patients/Consumers

  • Action Items: Benefit from a wider range of affordable medication options.

Key Entities Referenced

DCG(I): Drugs Controller General (India), responsible for drug regulation and approval in India. CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. BA/BE Studies: Bioavailability/Bioequivalence studies, conducted to compare the rate and extent of absorption of a generic drug to that of a reference drug. BCS Class II: Biopharmaceutics Classification System Class II: Drugs with low solubility and high permeability. BCS Class IV: Biopharmaceutics Classification System Class IV: Drugs with low solubility and low permeability.
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List of Products Permitted by DCG(I) and considered as Reference Product for BA/BE Studies CDSCO Sr. Name of drug/ Company/Trade Name of Drug BCS (Class II/IV) Product No. Name/Manufacturer) 1. Aceclofenac Tablet 100 mg PRESERVEX® (M/s. Almirall 1 Aceclofenac BCS CLASS-II (Two) Aceclofenac Tablets 100 mg Limited,(UK)) 2.M/s Abbot 3. M/s Intas Pharma 1. Acetazolamide Tablets 250 mg (M/s Acetazolamide Tablets 250 mg 2 Acetazolamide BCS CLASS-IV (Four) Taro Pharma Industries ltd. US) 2. M/s. Intas Pharma 1. Acitretin Capsules 10 mg SORIATANE® (M/s Stiefel Laboratories 3 Acitretin BCS CLASS-II (Two) Acitretin Capsules 10/25 mg Inc.) 2. Acitretin Capsules 10/25mg (M/s Glenmark pharma ltd.) 1. Acyclovir Tablets 200mg 4 Acyclovir BCS CLASS-IV (Four) Acyclovir Tablets 200 mg ACHIHERPIN® (M/s Agio) 2. M/s ZEE lab Albendazole Tablets 400 mg 5 Albendazole BCS CLASS-II (Two) Albendazole Tablets 400 mg ZENTEL® (M/s.GSK Pharma) 1. Allopurinol Tablets 100 mg (ZYLOPRIM®) (M/s. Casper Pharma 6 Allopurinol BCS CLASS-IV (Four) Allopurinol Tablets 100 mg Llc) 2. Allopurinol Tablets 100 mg ZYLORIC® (M/s GSK Pharma) Altretamine Capsules 50 mg 7 Altretamine BCS CLASS-II (Two) Altretamine Capsules 50 mg CANTRET® (M/s Natco Pharma) 1. Amiodarone Hydrochloride Tablets 100/200 mg CORDARONE® (M/s Amiodarone HCl Tablets 100/200 8 Amiodarone BCS CLASS-II (Two) Wyeth Pharmaceuticals Llc) mg 2. M/s Torrent Pharma 3. M/s Lupin Pharma 1. Amisulpride Tablets 50/100 mg SOLIAN® (M/s Sanofi Aventis) Amisulpride Tablets 9 Amisulpride BCS CLASS-IV (Four) 2. M/s Intas Pharma 50/100/200/300/400 mg 3. M/s Emcure Pharma 4. M/s Torrent Pharma 1. Amoxicillin Capsules 250/500mg 10 Amoxicillin BCS CLASS-IV (Four) Amoxicillin Capsules 250/500mg MOX® (M/s. Sun Pharma) 2. M/s Cipla Ltd. 1. Aprepitant Capsules 125 mg 11 Aprepitant BCS CLASS-II (Two) Aprepitant Capsules 80/125 mg EMEND® (M/s Merck and Co Inc) 2. M/s Sun Pharma Aripiprazole Tablets 10/15/20/30 Aripiprazole Tablets 10/15/20/30 mg 12 Aripiprazole BCS CLASS-II (Two) mg ARIP-MT® (M/s Torrent Pharma) Armodafinil Tablets 50/150 mg 13 Armodafinil BCS CLASS-II (Two) Armodafinil Tablets 50/150/250 mg WAKLERT® (M/s. Sun Pharma) 1. Artesunate Tablets 50 mg A- 14 Artesunate BCS CLASS-II (Two) Artesunate Tablets 50mg KEFTAL® (M/s Healthcare) 2. M/s. IPCA 1. Atazanavir Capsules Atazanavir Capsules 100/150/200/300mg REYATAZ® (M/s 15 Atazanavir BCS CLASS-II (Two) 100/150/200/300 mg Bristol Myers Squibb Co, USA) 2. M/s Emcure Pharma 1. Atorvastatin calcium Tablets 80 mg CADUET® (M/s Pfizer) Atorvastatin calcium Tablets 16 Atorvastatin BCS CLASS-II (Two) 2. M/s Dr. Reddy's Lab 5/10/20/40/80 3. M/s Sun Pharma 4. M/s Cadila Healthcare Ltd 1. Azathioprine Tablets 50mg AZASAN® (M/s AAIPHARMA LLC) 17 Azathioprine BCS CLASS- IV (Four) Azathioprine Tablets 50 mg 2. M/s Sebela Ireland Ltd 3. M/s Sun Pharma 4. M/s Alkem Lab 1. Azithromycin Tablets 250/500 mg ZITHROMAX® (M/s Pfizer Inc) 2. Azithromycin Tablet 250/500 mg 18 Azithromycin BCS CLASS-II (Two) Azithromycin Tablets 250/500 mg ZITHROLIDE® (M/s Pharmaniaga Manufacturing Berhad) 3. M/s Cipla Ltd 1. Bezafibrate Tablets 200 mg 19 Bezafibrate BCS CLASS-II (Two) Bezafibrate Tablets 200 mg BIZALIP® (M/s NPIL (Actis)) 2. M/s Abbot Page 1 of 9List of Products Permitted by DCG(I) and considered as Reference Product for BA/BE Studies CDSCO Sr. Name of drug/ Company/Trade Name of Drug BCS (Class II/IV) Product No. Name/Manufacturer) 1. Bicalutamide Tablets 50 mg CASODEX® (M/s ANI Pharma Inc, 20 Bicalutamide BCS CLASS-II (Two) Bicalutamide Tablets 50/150 mg USA) 2. Bicalutamide Tablets 150 mg CASODEX® (M/s AstraZeneca) 1. Bisacodyl Tablets 5 mg BIDLAX-5® (M/s GSK Pharma) 21 Bisacodyl BCS CLASS-II (Two) Bisacodyl Tablets 5 mg 2. M/s Sanofi Aventis 3. M/s Cipla Ltd 1. Cabergoline Tablets 0.5 mg (M/s PAR Pharma Inc) 22 Cabergoline BCS CLASS-II (Two) Cabergoline Tablets 0.5/1 mg 2. M/s Sun Pharma 3. M/s Svizera 4. M/s Sereum 1. Calcitriol Capsules 0.25/0.5 mcg ROCALTROL® (M/s Validus Pharmaceuticals Llc) 23 Calcitriol BCS CLASS-II (Two) Calcitriol Capsules 0.5/0.25 mcg 2. M/s Macleods Pharma 1. Candesartan Cilexetil Tablets 4/8/16 Candesartan cilexetil Tablets mg ATACAND® (M/s ANI 24 Candesartan cilexetil BCS CLASS-II (Two) 4/8/16 mg Pharmaceuticals Inc) 2. M/s Bal Pharma 1. M/s Shire Develepment LLC Carbamazepine Tablets 2. M/s Zydus cadila 25 Carbamazepine BCS CLASS- II (Two) 100/200/300 mg 3. M/s Torrent lab 4. M/s Sun laboratories 1. Carvedilol Tablets 3.125/6.25/12.5/ 25 mg COREG® (M/s Smithkline Carvedilol Tablet 26 Carvedilol BCS CLASS-II (Two) Beecham Ltd) 3.125/6.25/12.5/25 mg 2. Ms Intas Pharma 3. M/s Sun Pharma 1. Cefexime Capsules 100/200/400 mg RAXIM® (M/s Zydus Cadilla) Cefexime Capsules/Tablets 27 Cefixime BCS CLASS-IV (Four) 2. M/s Lupin Pharma 100/200/400 mg 3. M/s Novartis Healthcare Ltd. 4. M/s Macleods Pharma 1. Cefpodoxime proxetil Tablets 100/200 Cefpodoxime proxetil Tablets 28 Cefpodoxime proxetil BCS CLASS-IV (Four) mg (M/s Sandoz Inc 2. M/s 100/200 mg Aurobindo Pharma Ltd Ceftibuten Capsules 400mg (M/s Fulford 29 Ceftibuten BCS CLASS-IV (Four) Ceftibuten Capsules 200/400 mg India) 1. Cefuroxime axetil 125/250/500mg Cefuroxime axetil Tablets 125/ 30 Cefuroxime axetil BCS CLASS-IV (Four) tablets (M/s Lupin Ltd) 250/500 mg 2. M/s GlaxosmithKline Pharma 1. Celecoxib Capsules 50/100/200/400 mg CELEBREX® M/s GD Searle Llc. 2. M/s Sun Pharma, 31 Celecoxib BCS CLASS-II (Two) Celecoxib Capsules 100/200 mg 3. M/s Cadila, 4. M/s Dr.Reddy's Lab 5.M/s Lupin Lab 1. Cephalexin 250/500 mg Capsules, KEFLEX® (M/s Pragma Pharma Llc) Cephalexin Capsules 250/500mg 32 Cephalexin BCS CLASS-IV (Four) 2. Cephalexin Tablets 500 mg (Teva and Cephalexin Tablets 1000mg Pharma Inc) 3. M/s Sun Pharma 1. Cilostazol Tablet 50/100 mg M/s Teva Pharma USA Inc 2. M/s 33 Cilostazol BCS CLASS-II (Two) Cilostazol Tablets 50/100 mg Glenmark Pharma (M/s IPCA Lab) 3. M/s Cipla Ltd 4. M/s Sandoz 1. Cinacalet 30/60/90 mg Tablets Cinacalet (as HCl) Tablets SENSIPAR® (M/s Amgen Inc) 34 Cinacalcet BCS CLASS-IV (Four) 30/60/90 mg 2.M/s Biocon 3.M/s Intas Pharma Cisapride Monohydrate Tablets 10/20 35 Cisapride BCS CLASS-II (Two) Cisapride Tablets 5/10/20 mg mg , PROPULSID® (M/s. Janssen Pharma Inc) Page 2 of 9List of Products Permitted by DCG(I) and considered as Reference Product for BA/BE Studies CDSCO Sr. Name of drug/ Company/Trade Name of Drug BCS (Class II/IV) Product No. Name/Manufacturer) 1. Clarithromycin Tablets 250/500 mg (M/s Aurobindo Pharma Ltd) 36 Clarithromycin BCS CLASS-II (Two) Clarithromycin Tablets 250/500 mg 2. M/s Emcure 3. M/s GSK 4. M/s Abbott 1. Clofazimine Capsules 50/100 mg 37 Clofazimine BCS Class IV (Four) Clofazimine Capsule 50/100 mg (M/s Novartis Pharmaceuticals corp) 2. M/s AstraZeneca Clofibrate Capsules 500 mg ATROMID- 38 Clofibrate BCS CLASS-II (Two) Clofibrate Capsules 250 mg S® (M/s. Wyeth- Ayerst Laboratories) 1. Clopidogrel bisulphate Tablets 75/ 300 mg PLAVIX® (M/s. Sanofi Aventis Clopidogrel bisulphate Tablets 39 Clopidogrel bisulfate BCS CLASS-II (Two) US Llc) 75/150/300 mg 2. M/s Sun Pharma 3. M/s Abbott 1. Clozapine Tablets 25/100/200 mg CLOZARIL® (M/s. Heritage Life Sci. barbados Inc) 40 Clozapine BCS CLASS-II (Two) Clozapine Tablets 25/100/200 mg 2. M/s Intas Pharma 3. M/s Sun Pharma 4. M/s Sandoz Pvt Ltd. 1. Danazol Capsule 100/200 mg (M/s Barr Lab Inc) 41 Danazol BCS CLASS-II (Two) Danazol Capsules 100/200 mg 2. M/s Cipla Ltd 3. M/s Sun Pharma 1. Dapsone Tablets 25/100 mg (M/s 42 Dapsone BCS CLASS- II (Two) Dapsone Tablets 25/50/100 mg Virtus) 2. M/s GSK Pharma Ltd. 1.Darunavir Tablets 600/800 mg PREZISTA® (M/s Janssen) 43 Darunavir BCS CLASS-II (Two) Darunavir Tablets 300/600/800 mg 2. M/s Cipla Ltd 3. M/s Emcure Lab 1. Dasatinib Tablet 20/50/70mg SPRYCEL® (M/s.Bristol Myers Squibb 44 Dasatinib BCS CLASS-II (Two) Dasatinib Tablets 20/50/70/100 mg co.) 2. M/s. Natco Pharma Ltd 1. Desloratadine Tablets 5 mg CLARINEX® (M/s Merck Sharp and 45 Desloratadine BCS CLASS-II (Two) Desloratadine Tablets 5 mg Dohme Corp) 2. M/s SUN Pharma 3. M/s Ajanta 1. Dexamethasone Tablets 4/8 mg (M/s Sun Pharma) 2. 46 Dexamethasone BCS CLASS-II (Two) Dexamethasone Tablets 4/8 mg M/s Dr. Reddy's Lab 3. M/s Wockhardt Ltd 1. Diclofenac Sodium Tablet 50/75mg (M/s Mylan Pharms INC) 2. Diclofenac Sodium Tablet 25/50 mg Diclofenac Potassium Tablets (M/s Unique Pharma Labs) 25/50 mg 47 Diclofenac BCS CLASS-II (Two) 3. Diclofenac Sodium Tablet 100 mg Diclofenac Sodium Tablets (M/s Dexcel) 25/50/75/100/150 mg 4. Diclofenac Potassium Tablets 50 mg (M/s Teva) 5. M/s Novartis 1. Dipyridamole Tablets 12.5 mg (M/s Torrent Pharma) 48 Dipyridamole BCS CLASS-II (Two) Dipyridamole Tablets 12.5 mg 2. M/s Intas Pharma 3. M/s Zydus Healthcare 4. M/s Sun Pharma Dronedarone Tablet 400 mg 49 Dronedarone BCS CLASS-II (Two) Dronedarone Tablets 400 mg MULTAQ® (M/s. Sanofi Aventis US Llc) 1. Ebastine Tablets 10mg (M/s Abbott 50 Ebastine BCS CLASS-II (Two) Ebastine Tablets 10mg Pharma) 2. M/s Micro Labs Page 3 of 9List of Products Permitted by DCG(I) and considered as Reference Product for BA/BE Studies CDSCO Sr. Name of drug/ Company/Trade Name of Drug BCS (Class II/IV) Product No. Name/Manufacturer) 1. Efavirenz Capsules 50 mg SUSTIVA® (M/s. Bristol Myers Squibb Efavirenz Capsules 50/100/200 mg Co.) 2. M/s Cipla Ltd. 3. M/s Sun Pharma 51 Efavirenz BCS CLASS-II (Two) 1. Efavirenz Tablets 600 mg SUSTIVA®, (M/s Bristol Myers Squibb Efavirenz Tablet 600 mg Co.) 2. M/s Mylan Lab 3. M/s Cipla Ltd 1. Entocapone Tablets 200 mg COMTAN® 200 mg(M/s Orion Pharma) 52 Entacapone BCS CLASS-II (Two) Entocapone Tablets 200 mg 2. M/s Intas Pharma 3. M/s Sun Pharma 1. Erlotinib Hydrochloride Tablets, TARCEVA® 25 mg (M/s Osi Pharma Erlotinib hydrochloride Tablet 53 Erlotinib hydrochloride BCS CLASS-II (Two) Llc) 25/100/150 mg 2. M/s Glenmark Pharma 3. M/s Cipla Ltd Etodolac Tablet 200/400 mg (M/s IPCA Etodolac Tablet 200/400 mg Lab) 1. M/s Sandoz Etodolac Tablets 400 mg 2. M/s Teva Pharma, 54 Etodolac BCS CLASS-II (Two) 3. M/s Torrent Pharma 1. M/s M/s Taro Pharma Industries ltd 2. Etodolac Capsules 300 mg M/s ANI Pharma Inc 3. M/s Lupin Ltd 1. Etoposide Capsules 50 mg ACTITOP® (M/s Khandelwal) 55 Etoposide BCS CLASS-IV (Four) Etoposide Capsules 50 mg 2. M/s Cipla Ltd 3. M/s Mylan Lab 1. Exemestane Tablets 25 mg AROMASIN® (M/s Pharmacia and 56 Exemestane BCS CLASS-II (Two) Exemestane Tablets 25 mg Upjohn co.) 2. M/s Alkem Lab 3. M/s Natco Pharma 1. Ezetimibe Tablets 10 mg ZETIA® (M/s. MSD International GMBH) 57 Ezetimibe BCS CLASS-II (Two) Ezetimibe Tablets 10 mg 2. M/s Sun Pharma 3. M/s Lupin Lab 4. M/s Cadila healthcare Ltd. 1. Febuxostat Tablets 80/120 mg ULORIC® (M/s Takeda Pharma USA 58 Febuxostat BCS CLASS-II (Two) Febuxostat Tablets 80/120 mg Inc) 2. M/s Ajanta Pharma 3. M/s Intas Pharma Felbamate Tablets 400/600 mg 59 Felbamate BCS CLASS-II (Two) Felbamate Tablets 400/600 mg FELBATOL® (M/s Mylan Specialty LP) 1. Fenofibrate Tablet 145 mg (M/s Abbvie Inc) Fenofibrate Tablets 145 mg 2. M/s Cipla Ltd 60 Fenofibrate BCS CLASS-II (Two) 3. M/s Troikaa Pharma Ltd 4. M/s Sun Pharma Fenofibrate Capsules 200 mg M/s USV Ltd 1. Flecainide acetate Tablets 100 mg TAMBOCOR® (M/s. County Line 61 Flecainide acetate BCS CLASS-II (Two) Flecainide acetate Tablets 100 mg Pharma Line) 2. M/s Torrent Pharma 1. Flunarizine Capsule 5/10 mg NOMIGRAIN® (M/s Torrent) Flunarizine Capsule 5/10 mg 62 Flunarizine BCS CLASS-II (Two) 2. Flunarizine Tablets 10 mg MIGARID® Flunarizine Tablets 10 mg (M/s Cipla) 1. Flutamide Tablets 250 mg Euflex® 63 Flutamide BCS CLASS-II (Two) Flutamide Tablets 250 mg (M/s Merck Canada Inc.) 2. M/s Cipla Ltd Folic acid Tablets 5 mg FOLVITE®, (M/s 64 Folic acid BCS CLASS-IV (Four) Folic acid Tablets 5 mg Wyeth Pharmaceuticals Limited) Page 4 of 9List of Products Permitted by DCG(I) and considered as Reference Product for BA/BE Studies CDSCO Sr. Name of drug/ Company/Trade Name of Drug BCS (Class II/IV) Product No. Name/Manufacturer) 1. Furosemide Tablets 40 mg LASIX® 65 Furosemide BCS CLASS-IV (Four) Furosemide Tablets 40 mg (M/s US Pharm Holdings) 2. M/s Sandoz 1. Gefitinib Tablets 250 mg IRESAA® (M/s AstraZeneca Pharmaceuticals LP 66 Gefitinib BCS CLASS-II (Two) Gefitinib Tablets 250 mg UK) 2. M/s Natco Pharma 1. M/s Cadila Gemfibrozil Capsules 300 mg 2. M/s Pfizer 67 Gemfibrozil BCS CLASS-II (Two) 3. M/s Sun Pharma Gemfibrozil Tablets 600 mg LOPID® Gemfibrozil Tablets 600 mg (M/s.Pfizer) 1. Glimepiride Tablets, AMARYL® (M/s.Sanofi-aventis U.S. Llc) 68 Glimepiride BCS CLASS-II (Two) Glimepiride Tablets 1/2/3/4 mg 2. M/s Torrent Pharma 3. M/s IPCA 1. Griseofulvin Tablets 250/500 mg 69 Griseofulvin BCS CLASS-II (Two) Griseofulvin Tablets 125/ 500 mg GRISOVIN-FP® (M/s GSK) 1. M/s Johnson & Johnson 70 Haloperidol BCS CLASS-IV (Four) Haloperidol Tablets 1.5/5/10 mg 2. M/s Sun Pharma 3. M/s Intas 1. Hydroxychloroquine Tablets 400 mg PLAQUENIL® (M/s Sanofi-aventis Hydroxychloroquine Tablets 400 Canada Inc) 71 Hydroxychloroquine BCS CLASS-II (Two) mg 2. M/s IPCA 3. M/s Zydus 4. M/s Torrent Pharma 1. Ibrutinib Hard Gelatin Capsules 140 Ibrutinib Hard Gelatin Capsules mg IMBRUVICA® (M/s Pharmacyclics 72 Ibrutinib BCS CLASS-II (Two) 140 mg Inc.) 2. M/s Johnson & Johnson 1. M/s Abott Labs 73 Ibuprofen BCS CLASS-II (Two) Ibuprofen Tablets 200 mg 2. M/s Cipla Ltd 3. M/s Intas 1. M/s Sun Pharma Imatinib Capsules 100 mg 2. M/s Cipla Ltd 1. Imatinib Tablets 100/400 mg 74 Imatinib BCS CLASS-II (Two) GLEEVEC® (M/s Novartis Pharma) Imatinib Tablets 100/400 mg 2. M/s Natco Pharma 3. M/s Glenmark Pharma 1. Irbesartan Tablets 150/300 mg AVAPRO® (M/s Sanofi Aventis US Llc) 75 Irbesartan BCS CLASS-II (Two) Irbesartan Tablets 150/300 mg 2. M/s Sun Pharma 3. M/s Abbot 1. Isotretenoin soft gelatin Capsules 10/20 mg ABSORICA® (M/s Sun Isotretinoin soft gelatin Capsules 76 Isotretinoin BCS CLASS-II (Two) Pharma) 10/20 mg 2. Cipla Ltd. 3. M/s IPCA Lab 1. Itraconazole Capsules 100 mg SPORANOX® (M/s Janssen Pharma Inc) 77 Itraconazole BCS CLASS-II (Two) Itraconazole Capsules 100 mg 2. M/s Johnson & Johnson 3. M/s Glenmark Pharma 4. M/s Intas Pharma 1. M/s Glaxo India Ltd 78 Lacidipine BCS CLASS-II (Two) Lacidipine Tablets 2/4 mg 2. M/s Sun Pharma 1.M/s. Macleods Ltd 79 Lafutidine BCS CLASS-II (Two) Lafutidine Tablets 5/10mg 2. M/s. Ajanta Pharma 1. Lamotrigine Tablets 25/100 mg Lamotrigine-25/50/100 mg Tablets LAMICTAL (M/s GlaxoSmithKline Llc) 2. 80 Lamotrigine BCS CLASS-II (Two) M/s Sun Pharma 3. M/s Torrent Pharma Lapatanib film coated Tablets 250 Lapatanib film coated Tablets 250 mg 81 Lapatanib BCS CLASS-IV (Four) mg (M/s GlaxoSmithKline) 1. Leflunomide Tablets 10/20/100 mg ARAVA® (M/s Sanofi Aventis US Llc) 82 Leflunomide BCS CLASS-II (Two) Leflunomide Tablets 10/20/100 mg 2. M/s. Zydus Cadila 3. M/s Torrent Page 5 of 9List of Products Permitted by DCG(I) and considered as Reference Product for BA/BE Studies CDSCO Sr. Name of drug/ Company/Trade Name of Drug BCS (Class II/IV) Product No. Name/Manufacturer) 1. Lenalidomide Capsule 5/10/15/25 mg REVLIMID® (Celgene Corp) 2. M/s Lenalidomide Capsules 5/10/15/25 83 Lenalidomide BCS CLASS-IV (Four) Ranbaxy mg 3. M/s Natco Pharma Ltd 4. M/s Dr. Reddy's Lab 1. Losartan Potassium Tablets 25/50/100 mg COZAAR® (M/s Merck Losartan Potassium Tablets 84 Losartan Potassium BCS CLASS-II (Two) Sharp and Dohme Corp) 2. 25/50/100 mg M/s. Cadila 3. M/s Torrent Pharma 1. Lovastatin Tablets 10/20 mg AZTATIN® (M/s Sun Pharma) 85 Lovastatin BCS CLASS-II (Two) Lovastatin Tablets10/20 mg 2. M/s Glenmark 3. M/s Intas 1. Mebendazole Tablets 100 mg EMVERM® (M/s IMPAX LABS INC) 86 Mebendazole BCS CLASS-II (Two) Mebendazole Tablets100 mg 2. M/s Cipla Ltd 3. M/s Cadila 1. Meclizine Tablets 25 mg ANTIVERT® 87 Meclizine BCS CLASS-II (Two) Meclizine Tablets 25 mg (M/s CASPER PHARMA LLC) 2. M/s UCB 1. Mefloquine Hydrochloride Tablets 250 mg (M/s BARR) 88 Mefloquine BCS CLASS-II(Two) Mefloquine Tablets 250 mg 2. M/s Lupin 3. M/s Sun 1. Meloxicam Tablets 7.5/15 mg MOBIC® (M/s Boehringer Ingelheim 89 Meloxicam BCS CLASS-II(Two) Meloxicam Tablets 7.5/15 mg 2. M/s Cadila 3. M/s Sun Pharma 1. Mercaptopurine Tablets 50 mg PURINETHOL® (M/s Stason Pharms) 90 Mercaptopurine BCS CLASS- IV (Four) Mercaptopurine Tablets 50 mg 2. M/s GSK 3. M/s Mylan Lab 1. Mifepristone Tablets 200 mg MIFEPREX® (M/s Danco Lab Llc) 2. Mifepristone Tablets 200 mg 91 Mifepristone BCS CLASS-IV (Four) M/s Sun Pharma 3. M/s Abbott Healthcare Pvt. Ltd. 4. Cipla Limited 1 Nateglinide Tablets 60/120 mg NATEGLINIDE® (M/s Dr. Reddy's Lab) 92 Nateglinide BCS CLASS-II (Two) Nateglinide Tablets 60/120 mg 2. M/s Glenmark Pharma 3. IPCA 1. Nelfinavir Tablets 250mg 93 Nelfinavir Mesylate BCS CLASS-II (Two) Nelfinavir Tablets 250mg VIRACEPT® (M/s Agouron Pharms) 2. M/s Cipla 1. Nevirapine Tablets 200 mg 94 Nevirapine BCS CLASS-II (Two) Nevirapine Tablets 200mg (M/s Aurobindo Pharma) 2. M/s Cipla Ltd 1. Nifedipine Capsules 10 mg PROCARDIA® (M/s Pfizer) Nifedipine Capsules 5/10 mg 95 Nifedipine BCS CLASS-II (Two) 2. M/s. Merck 3. M/s Torrent Pharma 4. M/s Alkem Laboratories Ltd 1. Nimesulide Tablets 100 mg 96 Nimuselide BCS CLASS-II (Two) Nimesulide Tablets 100mg ANTIPEN® (M/s Dr. Reddy's Lab) 2. M/s Sun Pharma 1. Nitrazepam 5 mg Tablets, M/s Accord- UK Ltd 97 Nitrazepam BCS CLASS-II (Two) Nitrazepam Tablets 5/10 mg 2. Nitrazepam Tablets 5/10 mg NITROSUN® (M/s Sun Pharma) 3. M/s Lupin Laboratories Ltd 1. Nitrofurantoin Tablets 50 mg FURADANTIN® (M/s Procter and 98 Nitrofurantoin BCS CLASS-II (Two) Nitrofurantoin Tablets 50mg Gamble) 2. M/s Glaxo SmithKline Pharma Ltd. Page 6 of 9List of Products Permitted by DCG(I) and considered as Reference Product for BA/BE Studies CDSCO Sr. Name of drug/ Company/Trade Name of Drug BCS (Class II/IV) Product No. Name/Manufacturer) 1. Norfloxacin Tablets 200/400 mg Norfloxacin Tablets NORFLOX® (M/s Cipla Limited) 99 Norfloxacin BCS CLASS-IV(Four) 200/400/800mg 2. M/s Alembic Chemical Works Co. Ltd. 3. M/s Sun Pharma 1. Olanzapine Tablets 2.5/5/7.5/10/15/20mg ZYPREXA® (M/s Olanzapine Tablets 100 Olanzapine BCS CLASS-II (Two) Eli lilly & Co.) 2.5/5/7.5/10/15/20 mg 2. M/s Sun Pharma 1. Orlistat Capsules 120 mg XENICAL® (M/s Cheplapharm Arzneimittel GMBH) Orlistat Capsules 60mg ALLI® (M/s 101 Orlistat BCS CLASS-II (Two) Orlistat Capsules 60/120 mg GSK) 2. M/s Sun Pharma 3. M/s Meyer Organics Ltd 1. Oxcarbazepine Tablets 150/300/600 Oxcarbazepine Tablets mg TRILEPTAL® (M/s Novartis 102 Oxcarbazepine BCS CLASS-IV(Four) 150/300/600 mg Pharma) 2. M/s Sun Pharma 1.Pioglitazone Tablets15/30/45 mg ACTOS® (M/sTakeda Pharmaceuticals 103 Pioglitazone BCS CLASS-II(Two) Pioglitazone Tablets15/30/45 mg USA INC) 2. M/s Sun Pharma 3. M/s Dr Reddys 1. Praziquantel Tablets 600 mg 104 Praziquantel BCS CLASS-II (Two) Praziquantel Tablets 600 mg BILTRICIDE® (M/s Bayer Healthcare) 1. Primidone Tablets 250 mg 105 Primidone BCS CLASS-II(Two) Primidone Tablets 250 mg MYSOLINE® (M/s Valeant Pharma) 2. M/s Abbott Healthcare Pvt. Ltd 1. Quetiapine fumerate, SEROQUEL® Quetiapine Tablets 106 Quetiapen fumarate BCS CLASS-II (Two) (M/s Astrazeneca Pharmaceuticals) 25/50/100/200/300 mg 2. M/s Sun Pharma 1. Quinapril Tablets 5/10/20 mg Quinapril ACCUPRIL® (M/s Pfizer 107 BCS CLASS-II (Two) Quinapril Tablets 5/10/20 mg Hydrochloride Pharmaceuticals) 2. M/s Macleods Pharmaceuticals 1. Raloxifene Tablets 60 mg EVISTA® 108 Raloxifene BCS CLASS-II (Two) Raloxifene Tablets 60 mg (M/s Elililly & Co.) 2. M/s Dr. Reddys 1. Raltegravir Film coated tablets 400 Raltegravir Film coated tablets 400 mg ISENTRESS® 109 Raltegravir BCS CLASS-II (Two) mg (M/s MSD) 2. M/s Cipla 1. Rebamipide Tablets 100mg OXALIS® 110 Rebamipide BCS CLASS-II (Two) Rebamipide Tablets 100mg (M/s Macleods Pharmaceuticals) 2. M/s Ajanta Pharma 1. Rifabutin Capsules150mg MYCOBUTIN® (M/s Pharmacia & 111 Rifabutin BCS CLASS-II (Two) Rifabutin Capsules150mg Upjohn co.) 2. M/s Lupin 1. Rifampicin Capsules 150/300 mg Rifampicin Capsules 150/300/450 RIFADIN® (M/s Sanofi Aventis) 112 Rifampicin BCS CLASS-II (Two) mg 2. M/s Sandoz 3. M/s Lupin 1. M/s Johnson & Johnson 113 Risperidone BCS CLASS-II (Two) Risperidone Tablets 1/2/3/4 mg 2. M/s Torrent 2. M/s Sun Pharma 1. Ritonavir Capsules 100 mg NORVIR® 114 Ritonavir BCS CLASS-II (Two) Ritonavir Capsules 100 mg (M/s Abbvie INC) 2. M/s Cipla 1. Saquinavir Tablets 500mg INVIRASE® (M/s Hoffmann-la Roche 115 Saquinavir BCS CLASS-II (Two) Saquinavir Tablets 500mg Inc.) 2. M/s Hetero Healthcare 3. M/s Cipla 1.Simvastatin Tablets 5/10/20/40 mg ZOCOR® (M/s Merck Sharp & Dohme 116 Simvastatin BCS CLASS-II (Two) Simvastatin Tablets 5/10/20/40 mg Corp.) 2. M/s Sun Pharma Page 7 of 9List of Products Permitted by DCG(I) and considered as Reference Product for BA/BE Studies CDSCO Sr. Name of drug/ Company/Trade Name of Drug BCS (Class II/IV) Product No. Name/Manufacturer) 1. Sirolimus Tablets 0.5/1/2 mg 117 Sirolimus BCS CLASS-II (Two) Sirolimus Tablets 0.5/1/2 mg RAPAMUNE® (M/s PF PRISM CV) 2. M/s Wyeth Limited 1. Spironolactone Tablets 50 mg ALDACTONE® 118 Spironolactone BCS CLASS-II (Two) Spironolactone Tablets 50 mg (M/s GD SEARLE LLC) 2. M/s Sun Pharma 1. Sulfadiazine Tablets 500 mg 119 Sulfadiazine BCS CLASS-IV (Four) Sulfadiazine Tablets 500 mg SULFADIAZINE® (M/s Elililly & Co.) 2. M/s Sandoz Sulpiride Tablets 50/100/200/300 Sulpiride 200/400 mg Tablet 120 Sulpiride BCS CLASS-IV (Four) mg (M/s Wockhardt UK Ltd.) 1. Tacrolimus Capsules 0.5/ 1/5 mg PROGRAF® (M/s Astellas Pharma US Tacrolimus Capsules 0.25/0.5/ INC) 121 Tacrolimus BCS CLASS-II (Two) 1/3/4/5 mg 2. Tacrolimus Capsule 0.25/0.5/1/5mg PANGRAF® (M/s Panacea Biotec Ltd.) 3. M/s Torrent Pharmaceuticals Ltd. 1. Tadalafil Tablets 10/20 mg FORZEST® (M/s Sun Pharma) 122 Tadalafil BCS CLASS-IV(Four) Tadalafil Tablets 2.5/5/10/20 mg 2. M/s Astellas Pharma 2. M/s Lupin Ltd. 1.Telmisartan Tablets 20/40/80 mg 123 Telmisartan BCS CLASS-II (Two) Telmisartan Tablets 20/40/80 mg TELMA® (M/s Glenmark) 2. M/s Cipla 1. Terbinafine Tablets 250 mg LAMISIL® (M/s Novartis 124 Terbinafine BCS CLASS-II (Two) Terbinafine Tablets 250 mg Pharmaceuticals) 2. M/s Dr. Reddy's 1. Tiagabine HCl USP Tablets 2/4/12/16 Tiagabine Tiagabine HCl USP Tablets mg GABITRIL® (M/s Cephalon Inc. 125 BCS CLASS-II (Two) hydrochloride 2/4/12/16 mg USA) 2. M/s Sun Pharma 1. Tibolone Tablets 2.5 mg MAXTIB® (M/s Sun Pharma) 126 Tibolone BCS CLASS-II (Two) Tibolone Tablets 2.5 mg 2. M/s Cipla Limited 3. M/s Zydus Cadila Healthcare Ltd 4. M/s Organon 1. Ticlopidine HCl Tablets 250 mg (M/sTeva Pharmaceuticals) 127 Ticlopidine BCS CLASS-II (Two) Ticlopidine HCl Tablets 250 mg 2. M/s Cipla Limited 3. M/s Torrent Pharmaceuticals 4. M/s Emcure Pharmaceuticals 1. Tolvaptan Tablets 15/30 mg SAMSCA® (M/s Otsuka America Pharmaceutical Inc) 128 Tolvaptan BCS CLASS-II (Two) Tolvaptan Tablets 15/30 mg 2. M/s Glenmark Pharmaceuticals 3. M/s Sun Pharma 1. Torasemide Tablets 5/10/20/100 mg DEMADEX® (M/s Mylan Speciality LP) Torasemide Tablets 5/10/20/100 129 Torsemide BCS CLASS-II (Two) 2. M/s Cipla Limited mg 3. M/s Lupin Ltd 4. M/s Torrent Pharmaceuticals Ltd. 1. Tranexamic acid Tablets 250/500 mg Tranexamic acid Tablets 250/500 130 Tranexamic acid BCS CLASS-II (Two) TRANAREST® (M/s Zydus Cadila) mg 2. M/s Pfizer 1. Trimethoprim Tablets 100 mg 131 Trimethoprim BCS CLASS-IV (Four) Trimethoprim Tablets 100 mg (M/s Mayne Pharma) 2. M/s IPCA Laboratories Ltd. 1. Ursodeoxycholic acid Tablets Ursodeoxycholic acid Tablets 132 Ursodeoxycholic Acid BCS CLASS-II (Two) 300/600 mg UDILIV® (M/s Abbott) 300/600 mg 2. M/s Cadila Healthcare 1.Valsartan Tablets & Capsuels 40/80/160mg VALZAAR® Valsartan Tablets & Capsuels 133 Valsartan BCS CLASS-II (Two) (M/s Torrent Pharma) 40/80/160 mg 2. M/s Novartis Pharma (India) Ltd 3. M/s Lupin Laboratories Ltd Page 8 of 9List of Products Permitted by DCG(I) and considered as Reference Product for BA/BE Studies CDSCO Sr. Name of drug/ Company/Trade Name of Drug BCS (Class II/IV) Product No. Name/Manufacturer) 1. Vardenafil Hydrochloride Trihydrate Tablets 5 mg LEVITRA® Vardenafil Hydrochloride 134 Vardenafil BCS CLASS-II (Two) (M/s Ajanta Pharma) Trihydrate Tablets 5 mg 2. M/s Bayer plc, UK 3. M/s Macleods 1. Vemurafenib Tablets 240 mg Vemurafenib Tablets 240 mg ZELBORAF® (M/s Hoffmann La Roche 135 Vemurafenib BCS CLASS-IV (Four) Inc.) 2. M/s Roche Products Limited , UK 1. Verapamil Tablets 40/80/120 mg Verapamil Tablets 40/80/120/160 136 Verapamil BCS CLASS-II (Two) VASOPTEN® (M/s Torrent) mg 2. M/s Themis Medicare 1. Zafirlukast Tablets 10/20 mg ACCOLATE® (M/s AstraZeneca 137 Zafirlukast BCS CLASS-II (Two) Zafirlukast Tablets 10/20 mg Pharmaceuticals LP, USA) 2. M/s Dr. Reddy's Lab 1. Zaleplon Capsules 5/10 mg STILNITE® (M/s Zydus Cadila Healthcare Ltd) 138 Zaleplon BCS CLASS-II (Two) Zaleplon Capsules 5/10 mg 2. M/s Sonata and PFIZER INC, USA 3. M/s Zydus Cadila Healthcare 4. M/s Cipla 5. M/s Torrent Pharmaceuticals 1. Ziprasidone HCl Monohydrate Capsules 20/40/60/80 mg GEODON® Ziprasidone HCl Monohydrate 139 Ziprasidone BCS CLASS-II (Two) (M/s Pfizer Inc, USA) Capsules 20/40/60/80 mg 2. M/s Torrent Pharma 3. M/s Sun Pharma Page 9 of 9

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