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
11 Allopurinol Tablet 100 mg Zyloric DKL9932004210A1 Tanggal Terbit 21-01-2019 GLAXO WELLCOME INDONESIA - INDONESIA GLAXO WELLCOME INDONESIA - INDONESIA Obat Komparator
12 Alprazolam Kaplet 0,25 mg Xanax DPI1054200604A1 Tanggal Terbit 30-10-2020 PFIZER ITALIA S.R.L - ITALY PFIZER INDONESIA - INDONESIA Obat Komparator
13 Alprazolam Kaplet 0,5 mg Xanax DPI1054200604B1 Tanggal Terbit 30-10-2020 PFIZER ITALIA S.R.L - ITALY PFIZER INDONESIA - INDONESIA Obat Komparator
14 Alprazolam Kaplet 1 mg Xanax DPI1054200604C1 Tanggal Terbit 30-10-2020 PFIZER ITALIA S.R.L - ITALY PFIZER INDONESIA - INDONESIA Obat Komparator
15 Amiodarone Tablet 200 mg Cordarone DKL1421205810A1 Tanggal Terbit 21-10-2021 AVENTIS PHARMA - INDONESIA AVENTIS PHARMA - INDONESIA Obat Komparator
16 Amlodipine Besilate Tablet 5 mg Norvask DKL9219803410A1 Tanggal Terbit 08-10-2018 PFIZER INDONESIA - INDONESIA PFIZER INDONESIA - INDONESIA Obat Komparator
17 Amlodipine Besilate Tablet 10 mg Norvask DKL9619803410B1 Tanggal Terbit 08-10-2018 PFIZER INDONESIA - INDONESIA PFIZER INDONESIA - INDONESIA Obat Komparator
18 Amlodipine Besilate/ Valsartan Tablet Salut Selaput 5 mg/ 80 mg Exforge 5/80 DKI2197301017A1 Tanggal Terbit 09-09-2021 SIEGFRIED BARBERA, S.L. - SPAIN NOVARTIS INDONESIA - INDONESIA Obat Komparator
19 Amlodipine Besilate/ Valsartan Tablet Salut Selaput 5 mg/ 160 mg Exforge 5/160 DKI2197301017B1 Tanggal Terbit 09-09-2021 SIEGFRIED BARBERA, S.L. - SPAIN NOVARTIS INDONESIA - INDONESIA Obat Komparator
20 Amlodipine Besilate/ Valsartan Tablet Salut Selaput 10 mg/160 mg Exforge 10/160 DKI2197301017C1 Tanggal Terbit 09-09-2021 SIEGFRIED BARBERA, S.L. - SPAIN NOVARTIS 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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