BE Test Comparator Products

In order to update the "List of Equivalence Test Comparator Drugs and Generic Drugs that Meet Bioequivalence Criteria" which was published in 2020 and to support ease of application of Equivalence Test regulations for business actors, 3 (three) lists have been prepared as follows:

LIST OF EQUIVALENCE TEST COMPARATOR DRUG REGISTERED IN INDONESIA

No ZAT AKTIF BENTUK SEDIAAN KEKUATAN NAMA DAGANG NIE PRODUSEN PENDAFTAR STATUS
21 Amlodipine Besilate/ Atorvastatin Calcium Trihydrate Tablet Salut Selaput 10/ 10 mg Caduet DKI1258501317C1 Tanggal Terbit 22-07-2021 PFIZER- GERMANY PFIZER INDONESIA - INDONESIA Obat Komparator
22 Amlodipine Besilate/ Atorvastatin Calcium Trihydrate Tablet Salut Selaput 20/ 5 mg Caduet DKI1258501317B1 Tanggal Terbit 22-07-2021 PFIZER- GERMANY PFIZER INDONESIA - INDONESIA Obat Komparator
23 Amlodipine Besilate/ Atorvastatin Calcium Trihydrate Tablet Salut Selaput 20/ 10 mg Caduet DKI1258501317D1 Tanggal Terbit 22-07-2021 PFIZER- GERMANY PFIZER INDONESIA - INDONESIA Obat Komparator
24 Amlodipine Besilate/ Atorvastatin Calcium Trihydrate Tablet Salut Selaput 10/ 5 mg Caduet DKI1258501317A1 Tanggal Terbit 22-07-2021 PFIZER- GERMANY PFIZER INDONESIA - INDONESIA Obat Komparator
25 Amlodipine Besilate/ Bisoprolol Fumarate Tablet 5 mg/ 5 mg Concor AM DKI1952900110A1 Tanggal Terbit 28-03-2021 EGIS PHARMACEUTICALS PLC. MERCK TBK - INDONESIA Obat Komparator
26 Amlodipine Besilate/ Bisoprolol Fumarate Tablet 5 mg/ 10 mg Concor AM DKI1952900110B1 Tanggal Terbit 28-03-2021 EGIS PHARMACEUTICALS PLC. MERCK TBK - INDONESIA Obat Komparator
27 Amlodipine Besilate/ Bisoprolol Fumarate Tablet 10 mg/ 5 mg Concor AM DKI1952900110C1 Tanggal Terbit 28-03-2021 EGIS PHARMACEUTICALS PLC. MERCK TBK - INDONESIA Obat Komparator
28 Amoxicillin Sirup Kering 125 mg/ 5 mL Amoxsan DKL0732401438A1 Tanggal terbit 08 Februari 2022 CAPRIFARMINDO LABORATORIES - INDONESIA SANBE FARMA (UNIT 2) - INDONESIA Obat Komparator
29 Anastrozole Tablet Salut Selaput 1 mg Arimidex DKI1335300417A1 Tanggal Terbit 10-09-2022 ASTRAZENECA PHARMACEUTICALS LP - USA Dikemas dan Dirilis Oleh ASTRAZENECA PHARMACEUTICAL COMPANY LTD., WUXI, CHINA Untuk ASTRAZENECA UK LIMITED, MACCLESFIELD, UNITED KINGDOM ASTRAZENECA - INDONESIA Obat Komparator
30 Apixaban Tablet Salut Selaput 2,5 mg Eliquis DKI2190702117A1 Tanggal Terbit 17-11-2021 PFIZER IRELAND PHARMACEUTICALS - Ireland PFIZER INDONESIA - INDONESIA Obat Komparator

EQUIVALENCE TEST COMPARATOR DRUG LIST BASED ON SEARCH IN OTHER COUNTRIES

No ZAT AKTIF BENTUK SEDIAAN KEKUATAN NAMA DAGANG NIE PRODUSEN PENDAFTAR STATUS
41 Fluvastatin Tablet lepas lambat EQ 80MG BASE Lescol XL Malaysia, Australia Novartis Farmaceutica S.A, Spain (MY) Novartis -
42 Gemfibrozil Tablet 600 mg Lopid Australia, USA - Pfizer Pharmaceuticals Ltd -
43 Glipizide Tablet 5 mg Minidiab Malaysia, Australia Pfizer Italia S.R.L (MY) Pfizer -
44 Hydroxychloroquine Tablet 200 mg Plaquenil Malaysia, Australia - Sanofi-Aventis -
45 Indapamide Tablet 2.5 mg Natrilix Malaysia Les Labs Servier Industrie, France Servier Malaysia -
46 Indapamide Tablet pelepasan lambat 1.5 mg Natrilix SR Malaysia Les Labs Servier Industrie, France Servier Malaysia -
47 Isoniazid Tablet 50 mg; 100 mg; 200 mg Isozid Germany - Riemser Pharma GMBH -
48 Isoniazid Tablet 300 mg Isozid/Isoniazid (USA) USFA - Barr Laboratories Inc -
49 Isoniazid/Rifampicin Tablet salut selaput 150 mg/300 mg Rifinah Australia, UK, Netherland - Sanofi-Aventis Australia Pty Ltd (AU) Aventis Pharma Limited (UK) Genzyme Europe BV (NE) -
50 Ivermectin Tablet 3 mg Stromectol Australia, Singapore, USA - Merck Sharp & Dohme -

LIST OF GENERIC DRUGS THAT HAVE MEET THE BIOECIVALENCE CRITERIA IN 2022

No ZAT AKTIF BENTUK SEDIAAN KEKUATAN NAMA DAGANG NIE PRODUSEN PENDAFTAR STATUS
131 Cefixime Trihydrate Kaplet Salut Selaput 200 mg Ceptik 200 DKL0817623609A1 Tanggal Terbit 16-08-2022 INTERBAT - Indonesia INTERBAT - Indonesia Obat Generik
132 Cefixime Trihydrate Sirup Kering 100 mg/5 mL Cefarox DKL0435302738A1 Tanggal Terbit 22-06-2020 GRACIA PHARMINDO - INDONESIA GRACIA PHARMINDO - INDONESIA Obat Generik
133 Cefixime Trihydrate Sirup Kering 100 mg/5 mL Cefila DKL0813313938A1 Tanggal Terbit 28-08-2020 LAPI LABORATORIES - INDONESIA LAPI LABORATORIES - INDONESIA Obat Generik
134 Cefixime Trihydrate Sirup Kering 100 mg/5 mL Maxpro DKL9815613138A1 Tanggal Terbit 19-07-2020 MEPROFARM - INDONESIA MEPROFARM - INDONESIA Obat Generik
135 Cefixime Trihydrate Sirup Kering 100 mg/5 mL Anfix DKL0913705109A1 Tanggal Terbit 22-04-2021 DARYA VARIA LABORATORIA - INDONESIA MAHAKAM BETA FARMA - INDONESIA Obat Generik
136 Cefixime Trihydrate Sirup Kering 100 mg/5 mL Tocef DKL9602322838A1 Tanggal Terbit 16-02-2021 BERNOFARM - INDONESIA BERNOFARM - INDONESIA Obat Generik
137 Cefixime Trihydrate Sirup Kering 100 mg/5 mL Ceptik DKL9517611038A1 Tanggal Terbit 21-07-2022 INTERBAT - Indonesia INTERBAT - Indonesia Obat Generik
138 Cefixime Trihydrate Sirup Kering 100 mg/5 mL Starcef DKL9505014838A1 Tanggal Terbit 07-06-2022 DEXA MEDICA - INDONESIA DEXA MEDICA - INDONESIA Obat Generik
139 Cefixime Trihydrate Sirup Kering 100 mg/5 mL Profim DKL2233217538A1 Tanggal Terbit 04-03-2022 PROMEDRAHARDJO FARMASI INDUSTRI - Indonesia PROMEDRAHARDJO FARMASI INDUSTRI - INDONESIA Obat Generik
140 Cefixime Trihydrate Sirup Kering 100 mg/5 mL Cefixime Trihydrate GKL1340701738A1 Tanggal Terbit 06-12-2021 PHARMA LABORATORIES - Indonesia PHARMA LABORATORIES - Indonesia Obat Generik

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