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 |
|---|---|---|---|---|---|---|---|---|
| 81 | Clobazam | Tablet pelepasan lambat | 10 mg | Frisium | DPL0121203810A1 Tanggal Terbit 01-08-2018 | AVENTIS PHARMA INDONESIA | AVENTIS PHARMA -NDONESIA | Obat Komparator |
| 82 | Clodronate Disodium | Kapsul | 400 mg | Bonefos | DKI0775601101A1 Tanggal Terbit 04-01-2018 | BAYER SCHERING PHARMA OY - FINLAND | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 83 | Clodronate Disodium | Tablet Salut Selaput | 800 mg | Bonefos | DKI0775601217A1 Tanggal Terbit 04-01-2018 | BAYER SCHERING PHARMA OY - FINLAND | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 84 | Clopidogrel | Tablet Salut Selaput | 97,875 mg | Plavix | DKL1321205717A1 Tanggal Terbit 04-08-2019 | AVENTIS PHARMA - INDONESIA | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 85 | Clopidogrel | Tablet Salut Selaput | 391,5 mg | Plavix | DKI1377403617B1 Tanggal Terbit 18-03-2022 | SANOFI- WINTHROP - PERANCIS | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 86 | Cyproterone Acetate/ Ethinyl Estradiol | Tablet Salut Gula | 2 mg/ 0,035 mg | Diane 35 | DKI0868204416A1 Tanggal Terbit 30-08-2022 | BAYER WEIMAR GMBH UND CO. KG - Federal Republic of Germany | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 87 | Dabigatran Etexilate Mesilate | Kapsul | 110 mg | Pradaxa | DKI0952502201B1 Tanggal Terbit 23-10-2018 | BOEHRINGER INGELHEIM WEST GERMANY | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 88 | Dabigatran Etexilate Mesilate | Kapsul | 75 mg | Pradaxa | DKI0952502201A1 Tanggal Terbit 23-10-2018 | BOEHRINGER INGELHEIM WEST GERMANY | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 89 | Dabigatran Etexilate Mesilate | Kapsul | 172,95 mg | Pradaxa | DKI1152502201C1 Tanggal Terbit 04-10-2020 | BOEHRINGER INGELHEIM WEST GERMANY | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 90 | Dapaglifozin | Tablet Salut Selaput | 10 mg | Forxiga | DKI1735301317B1 Tanggal terbit 22-03-2018 | ASTRAZENECA INDONESIA - INDONESIA | ASTRAZENECA UK LIMITED | 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 |
|---|---|---|---|---|---|---|---|---|
| 81 | Bicalutamide | Tablet Salut Selaput | 50 mg | Promod 50 | DKI1935400617A1 Tanggal Terbit 12-10-2019 | INTAS PHARMACEUTICAL LTD. - INDIA | MERSIFARMA TIRMAKU MERCUSANA - INDONESIA | Obat Generik |
| 82 | Bicalutamide | Tablet Salut Selaput | 150 mg | Biluron 150 | DKI1943400517B1 Tanggal Terbit 06-12-2019 | SYNTHON HISPANIA, S.L. - Spain | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 83 | Bicalutamide | Tablet Salut Selaput | 50 mg | Bicastra | DKI1618600817A1 Tanggal Terbit 23-03-2021 | HETERO LABS LIMITED - INDIA | FERRON PAR PHARMACEUTICALS - INDONESIA | Obat Generik |
| 84 | Bicalutamide | Tablet Salut Selaput | 150 mg | Calutami 150 | DKI1884400517B1 Tanggal Terbit 21-01-2019 | CHONG KUN DANG PHARMACEUTICAL - REPUBLIC OF KOREA | OTTO PHARMACEUTICAL INDUSTRIES - INDONESIA | Obat Generik |
| 85 | Bicalutamide | Tablet Salut Selaput | 50 mg | Biluron 50 | DKI1943400517A1 Tanggal Terbit 06-12-2019 | SYNTHON HISPANIA, S.L. - Spain | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 86 | Bisoprolol fumarate | Tablet salut selaput | 5 mg | Tencard | DKL2144403617B1 Tanggal Terbit 01-11-2021 | KIMIA FARMA Tbk. - Indonesia | KIMIA FARMA Tbk. - Indonesia | Obat Generik |
| 87 | Bisoprolol Fumarate | Tablet Salut Selaput | 5 mg | Selbix | DKL1702354617A1 Tanggal Terbit 17-10-2018 | BERNOFARM - INDONESIA | BERNOFARM - INDONESIA | Obat Generik |
| 88 | Bisoprolol Fumarate | Tablet Salut Selaput | 5 mg | Konblobet | DKL2013028017A1 Tanggal Terbit 18-08-2021 | KONIMEX - INDONESIA | KONIMEX - INDONESIA | Obat Generik |
| 89 | Bisoprolol Fumarate | Tablet Salut Selaput | 5 mg | Miniten | DKL13025025117A1 Tanggal Terbit 14-03-2018 | DIPA PHARMALAB INTERSAINS - INDONESIA | DIPA PHARMALAB INTERSAINS - INDONESIA | Obat Generik |
| 90 | Bisoprolol Fumarate | Tablet Salut Selaput | 5 mg | Bisoprolol Fumarate | GKL0633516517A1 Tanggal Terbit 21-03-2019 | ETERCON PHARMA - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
