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
501 Mycophenolate Mofetil Tablet salut selaput 500 mg Mycocell DKI1953400117A1 Tanggal Terbit 23-08-2019 ALKEM LABORATORIES LIMITED-INDIA PHAPROS - INDONESIA Obat Generik
502 Mycophenolate Mofetil Kaplet Salut Selaput 500 mg Kamyfet DKL1811645409A1 Tanggal Terbit 30-01-2019 KALBE FARMA - INDONESIA KALBE FARMA - INDONESIA Obat Generik
503 Mycophenolate Mofetil Kaplet Salut Selaput 500 mg Celmunos DKI2055900109A1 Tanggal Terbit 02-08-2020 CONCORD BIOTECH LTD. - INDIA SOHO INDUSTRI PHARMASI - INDONESIA Obat Generik
504 Mycophenolate Sodium Tablet Salut Enterik 384,70 mg Mycophen 360 DKI2055900215B1 Tanggal Terbit 19-09-2020 CONCORD BIOTECH LTD. - INDIA SOHO INDUSTRI PHARMASI - INDONESIA Obat Generik
505 Nebivolol Hydrochloride Tablet 5 mg Nebivolol GKL2033550010A1 Tanggal Terbit 04-10-2020 DEXA MEDICA - INDONESIA DEXA MEDICA - INDONESIA Obat Generik
506 Nebivolol Hydrochloride Tablet 5,450 mg Linoven DKL2033550110A1 Tanggal Terbit 04-10-2020 NOVELL PHARMACEUTICAL LAB - INDONESIA NOVELL PHARMACEUTICAL LAB - INDONESIA Obat Generik
507 Nifedipine Tablet pelepasan Lambat 10 mg Farmalat ER DKL8831500314A1 Tanggal Terbit 16-12-2019 PRATAPA NIRMALA - INDONESIA PRATAPA NIRMALA - INDONESIA Obat Generik
508 Nomegestrol Acetate Tablet Salut Selaput 5 mg Prodefi DKL2133553417A1 Tanggal Terbit 10-12-2021 ETERCON PHARMA - INDONESIA NOVELL PHARMACEUTICAL LAB - INDONESIA Obat Generik
509 Ofloxacin Tablet salut selaput 400 mg Akilen 400 DKL9522213017B1 Tanggal Terbit 31-12-2018 SANBE FARMA - INDONESIA SANBE FARMA - INDONESIA Obat Generik
510 Ofloxacin Tablet salut selaput 400 mg Ofloxacin GKL0005029617B1 Tanggal Terbit 08-04-2022 DEXA MEDICA - INDONESIA DEXA MEDICA - INDONESIA Obat Generik

Article

See More

RINGKASAN PRAKTIS PERATURAN TERBARU UNTUK PENDAFTAR UJI KLINIK DAN OBAT PENGEMBANGAN BARU

HATI-HATI PENYALAHGUNAAN OBAT-OBAT TERTENTU (OOT)

tes