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
31 Apixaban Tablet Salut Selaput 5 mg Eliquis DKI2190702117B1 Tanggal Terbit 22-04-2021 PFIZER IRELAND PHARMACEUTICALS - Ireland PFIZER INDONESIA - INDONESIA Obat Komparator
32 Aripiprazole Orally Disintegrating Tablet 15 mg Abilify Discmelt DKI1509700681B1 Tanggal Terbit 17-06-2021 KOREA OTSUKA PHARMACEUTICAL - REPUBLIC OF KOREA OTSUKA INDONESIA - INDONESIA Obat Komparator
33 Aripiprazole Orally Disintegrating Tablet 10 mg Abilify Discmelt DKI1509700681A1 Tanggal Terbit 17-06-2021 KOREA OTSUKA PHARMACEUTICAL - REPUBLIC OF KOREA OTSUKA INDONESIA - INDONESIA Obat Komparator
34 Aripiprazole Tablet 10 mg Abilify DKI0409700110A1 Tanggal Terbit 22-04-2020 KOREA OTSUKA PHARMACEUTICAL - REPUBLIC OF KOREA OTSUKA INDONESIA - INDONESIA Obat Komparator
35 Aripiprazole Tablet 15 mg Abilify DKI0409700110B1 Tanggal Terbit 22-04-2020 KOREA OTSUKA PHARMACEUTICAL - REPUBLIC OF KOREA OTSUKA INDONESIA - INDONESIA Obat Komparator
36 Aripiprazole Tablet 5 mg Abilify DKI0809700110DI Tanggal Terbit 28-03-2018 KOREA OTSUKA PHARMACEUTICAL - REPUBLIC OF KOREA OTSUKA INDONESIA - INDONESIA Obat Komparator
37 Atorvastatin Calcium Trihydrate Tablet Salut Selaput 10 mg Lipitor DKI9790700217A1 Tanggal Terbit 03-06-2022 PFIZER PHARMACEUTICALS LLC, VEGA BAJA, UNITED STATES OF AMERICA Dikemas dan Dirilis Oleh PFIZER MANUFACTURING DEUTSCHLAND GMBH, FREIBURG, FEDERAL REPUBLIC OF GERMANY PFIZER INDONESIA - INDONESIA Obat Komparator
38 Atorvastatin Calcium Trihydrate Tablet Salut Selaput 80 mg Lipitor DKI1790700217D1 Tanggal Terbit 10-01-2021 PFIZER PHARMACEUTICALS LLC, VEGA BAJA, UNITED STATES OF AMERICA Dikemas dan Dirilis Oleh PFIZER MANUFACTURING DEUTSCHLAND GMBH, FREIBURG, FEDERAL REPUBLIC OF GERMANY PFIZER INDONESIA - INDONESIA Obat Komparator
39 Atorvastatin Calcium Trihydrate Tablet Salut Selaput 40 mg Lipitor DKI9790700217C1 Tanggal Terbit 07-06-2022 PFIZER PHARMACEUTICALS LLC, VEGA BAJA, UNITED STATES OF AMERICA Dikemas dan Dirilis Oleh PFIZER MANUFACTURING DEUTSCHLAND GMBH, FREIBURG, FEDERAL REPUBLIC OF GERMANY PFIZER INDONESIA - INDONESIA Obat Komparator
40 Atorvastatin Calcium Trihydrate Tablet Salut Selaput 20 mg Lipitor DKI9790700217B1 Tanggal Terbit 03-06-2022 PFIZER PHARMACEUTICALS LLC, VEGA BAJA, UNITED STATES OF AMERICA Dikemas dan Dirilis Oleh PFIZER MANUFACTURING DEUTSCHLAND GMBH, FREIBURG, FEDERAL REPUBLIC OF GERMANY 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
51 Ketoconazole Tablet 200 mg Ketoconazole USA - TARO PHARMACEUTICAL INDUSTRIES LTD -
52 Ketoprofen Tablet pelepasan lambat 150 mg Bi-Profenid Poland - Sanofi-Aventis -
53 Ketoprofen Kapsul pelepasan lambat 200 mg Profenid LP 200 France; Austria - Sanofi-Aventis, France; Sanofi-Aventis, Austria -
54 Ketoprofen Kapsul 50 mg Profenid France; Austria - Sanofi-Aventis, France; Sanofi-Aventis, Austria -
55 Ketoprofen Tablet salut selaput 100 mg Profenid France; Austria - Sanofi-Aventis, France; Sanofi-Aventis, Austria -
56 Lansoprazole Kapsul lepas tunda 30 mg Takepron atau Prevacid Australia, USA, UK - Takeda Teva atau Takeda -
57 Lenalidomide Kapsul 25 mg Revlimid Malaysia, USA - Celgene International Switzerlan (MY); Celgene Corp (US) -
58 Levodopa (kombinasi Carbidopa) Tablet 200 mg/50 mg Sinemet CR Singapore - ORGANON SINGAPORE PTE. LTD. -
59 Levodopa (kombinasi Carbidopa) Tablet 200 mg/50 mg Sinemet CR Australia - ORGANON PHARMA PTY LTD -
60 Lisinopril Tablet Lisinopril 5 mg; 10 mg; 20 mg Zestril Malaysia, Philippines, Australia Aztrazeneca Pharmaceutical Co. Ltd, China (MY, PH) AstraZeneca Pharmaceutical -

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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