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
1 Abiraterone Acetate Tablet 250 mg Zytiga DKI1410900810A1 Tanggal Terbit 21-01-2019 JANSSEN CILAG FARMACEUTICAL SpA - ITALY SOHO INDUSTRI PHARMASI - INDONESIA Obat Komparator
2 Abiraterone Acetate Tablet Salut Selaput 500 mg Zytiga DKI1810901417A1 Tanggal Terbit 12-09-2019 JANSSEN CILAG FARMACEUTICAL SpA - ITALY SOHO INDUSTRI PHARMASI - INDONESIA Obat Komparator
3 Acetylsalicylic Acid Tablet Salut Enterik 100 mg Cardio Aspirin DKI9451600515A1 Tanggal Terbit 17-02-2022 BAYER AG, LEVERKUSEN, FEDERAL REPUBLIC OF GERMANY UNTUK BAYER CONSUMER CARE AG, BASEL, SWITZERLAND BAYER INDONESIA - INDONESIA Obat Komparator
4 Acetylsalicylic Acid/ Clopidogrel Tablet Salut Selaput 75 mg/ 100 mg Coplavix DKI1977404315A1 Tanggal Terbit 04-04-2019 SANOFI- WINTHROP - PERANCIS AVENTIS PHARMA - INDONESIA Obat Komparator
5 Aciclovir Tablet 200 mg Zovirax DKI1691601310A1 Tanggal Terbit 11-10-2021 GLAXO WELLCOME S.A., ARANDA DE DIERO, SPAIN GLAXO WELLCOME INDONESIA - INDONESIA Obat Komparator
6 Adefovir Dipivoxil Tablet 10 mg Hepsera DKI1033700110A1 Tanggal Terbit 13-09-2019 GLAXO SMITHKLINE CO. LTD - (TIANJIN) CHINA SMITH KLINE BEECHAM PHARMACEUTICAL IND. - INDONESIA Obat Komparator
7 Agomelatine Tablet Salut Selaput 25 mg Valdoxan DKI1668601517A1 Tanggal Terbit 16-02-2022 LES LABORATORIES SERVIER - FRANCE DARYA VARIA LABORATORIA - INDONESIA Obat Komparator
8 Aliskiren Fumarate Tablet Salut Selaput 150 mg Rasilez DKI0767506817A1 Tanggal Terbit 18-01-2018 NOVARTIS PHARMA STEIN A.G., STEIN - SWISS NOVARTIS INDONESIA - INDONESIA Obat Komparator
9 Aliskiren Fumarate Tablet Salut Selaput 300 mg Rasilez DKI0767506817B1 Tanggal Terbit 18-01-2018 NOVARTIS PHARMA STEIN A.G., STEIN - SWISS NOVARTIS INDONESIA - INDONESIA Obat Komparator
10 Allopurinol Tablet 100 mg Zyloric DKL9932004210A1 Tanggal Terbit 21-01-2019 GLAXO WELLCOME INDONESIA - INDONESIA GLAXO WELLCOME 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
31 Efavirenz Tablet 600 mg Stocrin/ Sustiva Malaysia, Australia, USA - Merck Sharp & Dohme (Australia) Bristol Myers Squibb (USA) -
32 Efavirenz Kapsul 50 mg; 200 mg Sustiva USA - Bristol Myers Squibb -
33 Efavirenz (kombinasi dengan Emtricitabine dan Tenofovir) Tablet 600 mg/200mg/ 300 mg Atripla Australia, USA - Gilead Sciences -
34 Efavirenz (kombinasi dengan Lamivudine dan Tenofovir) Tablet 600 mg/300 mg/300 mg Symfi USA - Mylan Laboratories Ltd -
35 Efavirenz (kombinasi dengan Lamivudine dan Tenofovir) Tablet 400 mg/300 mg/300 mg Symfi Lo USA - Mylan Pharmaceuticals Inc -
36 Emtricitabine (kombinasi Tenofovir) Tablet 200/300 mg Truvada Australia, USA - Gilead Sciences -
37 Enalapril Tablet 2,5 mg; 5 mg; 10 mg Vasotec USA - BAUSCH HEALTH US LLC -
38 Entecavir Tablet Salut Selaput 0,5 mg; 1 mg Baraclude Singapore, USA, Philippines AstraZeneca Pharmaceuticals UNITED STATES, USA Bristol Myers Squibb -
39 Ethambutol Tablet 400 mg Myambutol Germany, Switzerland, USA, UK - Riemser Arzneimittel or Teopharma; Labatec Pharma, Switzerland; STI Pharma LLC, USA; Genus Pharmaceuticals Ltd, UK -
40 Felodipine Tablet pelepasan lambat 1,5 mg; 5 mg; 10 mg Plendil Malaysia, Philippines Aztrazeneca Pharmaceutical Co. Ltd, China Astrazeneca -

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

No ZAT AKTIF BENTUK SEDIAAN KEKUATAN NAMA DAGANG NIE PRODUSEN PENDAFTAR STATUS
521 Omeprazole Kapsul lepas tunda 20 mg Norsec DKL9508003303A1 Tanggal Terbit 27-11-2018 GUARDIAN PHARMATAMA - INDONESIA GUARDIAN PHARMATAMA - INDONESIA Obat Generik
522 Omeprazole Kapsul lepas tunda 20 mg Omz DKL1134609503A2 Tanggal Terbit 8-11-2018 DEXA MEDICA - INDONESIA FERRON PAR PHARMACEUTICALS - INDONESIA Obat Generik
523 Omeprazole Kapsul lepas tunda 20 mg Omed 20 DKL1039200403A1 Tanggal Terbit 04-10-2022 MEGA LIFESCIENCES INDONESIA - Indonesia MEGA LIFESCIENCES INDONESIA - Indonesia Obat Generik
524 Omeprazole Pellet Kapsul lepas tunda 0.085 Ozid DKL9904514403A1 Tanggal Terbit 28-08-2020 DARYA VARIA LABORATORIA TBK PLANT CITEUREUP - INDONESIA DARYA VARIA LABORATORIA - INDONESIA Obat Generik
525 Omeprazole Pellet Kapsul lepas tunda 0.085 Rindopump DKL9832707203A1 Tanggal Terbit 14-01-2020 YARINDO FARMATAMA - INDONESIA YARINDO FARMATAMA - INDONESIA Obat Generik
526 Ondansetron Hydrochloride Dihydrate Tablet cepat larut 10 mg Ondane-8 DKL1908026681B1 Tanggal Terbit 14-11-2020 GUARDIAN PHARMATAMA - INDONESIA GUARDIAN PHARMATAMA - INDONESIA Obat Generik
527 Oseltamivir Phosphate Kapsul 98,527 mg Fluvir DKI2018603301A1 Tanggal Terbit 01-05-2020 HETERO LABS LIMITED - INDIA AMAROX PHARMA GLOBAL - INDONESIA Obat Generik
528 Oseltamivir Phosphate Kapsul 98,527 mg Nocovir 75 DKI2054800901A1 Tanggal Terbit 13-01-2021 MACLEODS PHARMACEUTICALS LIMITED - INDIA SAMPHARINDO RETROVIRAL INDONESIA - INDONESIA Obat Generik
529 Pantoprazole Tablet salut enterik 40 mg Pepzol 40 DKL1213706615B1 Tanggal Terbit 17-11-2021 MAHAKAM BETA FARMA - INDONESIA MAHAKAM BETA FARMA - INDONESIA Obat Generik
530 Pantoprazole Tablet salut enterik 40 mg Pantopump 40 DKL1617627207A1 Tanggal Terbit 27-02-2021 INTERBAT - INDONESIA INTERBAT - INDONESIA Obat Generik

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