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
111 Divalproex sodium Tablet salut enterik 250 mg Depakote DKL0400203115A1 Tanggal Terbit 01-09-2020 ABBOTT INDONESIA-INDONESIA DENGAN LISENSI ABBOTT LABORATORIES - UNITED STATES OF AMERICA ABBOTT INDONESIA - INDONESIA Obat Komparator
112 Dolutegravir Tablet 50 mg Tivicay DKI1991601417A1 Tanggal Terbit 12-06-2019 GLAXO WELLCOME SA - SPAIN GLAXO WELLCOME INDONESIA - INDONESIA Obat Komparator
113 Domperidone Tablet Salut Selaput 10 mg Motilium DKL1124401017A1 Tanggal Terbit 25-11-2020 TAISHO PHARMACEUTICAL INDONESIA TBK - INDONESIA TAISHO PHARMACEUTICAL INDONESIA TBK - INDONESIA Obat Komparator
114 Donepezil HCl Tablet Salut Selaput 5 mg Aricept DKI0824400117A1 Tanggal Terbit 23-04-2018 BORA PHARM CO. LTD - TAIWAN EISAI INDONESIA - INDONESIA Obat Komparator
115 Donepezil HCl Tablet Dispersible 5 mg Aricept Evess DKI1729000392C1 Tanggal Terbit 02-10-2018 INTERTHAI PHARMACEUTICAL MANUFACTURING, THAILAND EISAI INDONESIA - INDONESIA Obat Komparator
116 Donepezil HCl Tablet Orodispersible 10 mg Aricept Evess DKI1029000392B1 Tanggal Terbit 06-12-2019 BUSHU PHARMACEUTICALS LTD. - Japan Pemberi Lisensi EISAI CO., LTD. - Japan EISAI INDONESIA - INDONESIA Obat Komparator
117 Duloxetine HCl Kapsul 30 mg Cymbalta DKI1973402001A1 Tanggal Terbit 09-07-2021 LILLY SA - SPANYOL PYRIDAM FARMA - INDONESIA Obat Komparator
118 Duloxetine HCl Kapsul 60 mg Cymbalta DKI1973402001B1 Tanggal Terbit 16-07-2021 LILLY SA - SPANYOL PYRIDAM FARMA - INDONESIA Obat Komparator
119 Dutasteride Kapsul lunak 0,5 mg Avodart DKI1333900102A1 Tanggal Terbit 29-03-2018 GLAXO SMITHKLINE PHARMACEUTICAL S.A - POLAND SMITH KLINE BEECHAM PHARMACEUTICAL IND. - INDONESIA Obat Komparator
120 Dydrogesterone Tablet Salut Selaput 10 mg Duphaston DKI1081601317A1 Tanggal Terbit 01-09-2020 ABBOTT BIOLOGICALS B.V - NETHERLANDS ABBOTT 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
81 Nevirapine Tablet pelepasan lambat 400 mg Viramune USA, Australia - Boehringer Ingelheim -
82 Nifedipine Kapsul 10 mg Procardia USA - Pfizer -
83 Nifedipine Tablet 10 mg; 20 mg Adalat Australia - Bayer -
84 Nitroglycerin Tablet sublingual 0,3; 0,4 dan 0,6 mg Nitrostat USA - UPJOHN US 1 LLC -
85 Omeprazole Kapsul lepas tunda 20 mg Losec Philippines; New Zealand, Sweden Astra Zeneca AB, Sweden - -
86 Ondansetron Tablet salut selaput 8 mg; 4 mg Zofran Austria; EU - Novartis Pharma GmbH, Austria -
87 Piroxicam Kapsul 20 mg Feldene USA, France Fareva Amboise (FR) Pfizer Laboratories -
88 Pravastatin TABLET 80 mg Pravastatin Sodium USA - Teva Pharmaceuticals USA -
89 Primaquine Tablet 15 mg Primaquine Phosphate USA - Sanofi Aventis US LLC -
90 Pyrazinamide Tablet 500 mg Pyrafat Germany - Riemser Pharma GMBH -

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

No ZAT AKTIF BENTUK SEDIAAN KEKUATAN NAMA DAGANG NIE PRODUSEN PENDAFTAR STATUS
661 Zolpidem Tartrate Tablet salut selaput 10 mg Zolmia DPL0331523217A1 Tanggal Terbit 09-09-2021 PRATAPA NIRMALA - INDONESIA PRATAPA NIRMALA - INDONESIA Obat Generik
662 Zolpidem Tartrate Tablet salut selaput 10 mg Zolta DPL1233526617A1 Tanggal Terbit 23-06-2022 NOVELL PHARMACEUTICAL LAB - INDONESIA NOVELL PHARMACEUTICAL LAB - INDONESIA Obat Generik

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