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 |
|---|---|---|---|---|---|---|---|---|
| 41 | Fluvastatin | Tablet lepas lambat | EQ 80MG BASE | Lescol XL | Malaysia, Australia | Novartis Farmaceutica S.A, Spain (MY) | Novartis | - |
| 42 | Gemfibrozil | Tablet | 600 mg | Lopid | Australia, USA | - | Pfizer Pharmaceuticals Ltd | - |
| 43 | Glipizide | Tablet | 5 mg | Minidiab | Malaysia, Australia | Pfizer Italia S.R.L (MY) | Pfizer | - |
| 44 | Hydroxychloroquine | Tablet | 200 mg | Plaquenil | Malaysia, Australia | - | Sanofi-Aventis | - |
| 45 | Indapamide | Tablet | 2.5 mg | Natrilix | Malaysia | Les Labs Servier Industrie, France | Servier Malaysia | - |
| 46 | Indapamide | Tablet pelepasan lambat | 1.5 mg | Natrilix SR | Malaysia | Les Labs Servier Industrie, France | Servier Malaysia | - |
| 47 | Isoniazid | Tablet | 50 mg; 100 mg; 200 mg | Isozid | Germany | - | Riemser Pharma GMBH | - |
| 48 | Isoniazid | Tablet | 300 mg | Isozid/Isoniazid (USA) | USFA | - | Barr Laboratories Inc | - |
| 49 | Isoniazid/Rifampicin | Tablet salut selaput | 150 mg/300 mg | Rifinah | Australia, UK, Netherland | - | Sanofi-Aventis Australia Pty Ltd (AU) Aventis Pharma Limited (UK) Genzyme Europe BV (NE) | - |
| 50 | Ivermectin | Tablet | 3 mg | Stromectol | Australia, Singapore, USA | - | Merck Sharp & Dohme | - |
LIST OF GENERIC DRUGS THAT HAVE MEET THE BIOECIVALENCE CRITERIA IN 2022
| No | ZAT AKTIF | BENTUK SEDIAAN | KEKUATAN | NAMA DAGANG | NIE | PRODUSEN | PENDAFTAR | STATUS |
|---|---|---|---|---|---|---|---|---|
| 91 | Bisoprolol Fumarate | Tablet Salut Selaput | 5 mg | Bisoprolol | GKL0608513317A1 Tanggal Terbit 22-04-2022 | HEXPHARM JAYA LABORATORIES - INDONESIA | HEXPHARM JAYA LABORATORIES - INDONESIA | Obat Generik |
| 92 | Bisoprolol Fumarate | Tablet Salut Selaput | 5 mg | Biscor | DKL0605041617A1 Tanggal Terbit 28-01-2019 | FERRON PAR PHARMACEUTICALS - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 93 | Bisoprolol Fumarate | Tablet Salut Selaput | 5 mg | Bisoprolol Fumarate | GKL0633516517A1 Tanggal Terbit 21-03-2019 | ETERCON PHARMA - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 94 | Bisoprolol Fumarate | Tablet Salut Selaput | 5 mg | Opiprol 5 | DKL1718829417B1 Tanggal Terbit 23-03-2018 | OTTO PHARMACEUTICALS INDUSTRIES - INDONESIA | OTTO PHARMACEUTICAL INDUSTRIES - INDONESIA | Obat Generik |
| 95 | Candesartan Cilexetil | Tablet | 16 mg | Canderin | DKL1105045910B1 Tanggal Terbit 16-07-2021 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 96 | Candesartan Cilexetil | Tablet | 16 mg | Gionix | DKL1521645010B1 Tanggal Terbit 12-04-2022 | PHAROS INDONESIA - INDONESIA | PHAROS INDONESIA - INDONESIA | Obat Generik |
| 97 | Candesartan Cilexetil | Tablet | 16 mg | Candesartan cilexetil | GKL2208520810A1 Tanggal Terbit 19-04-2022 | HEXPHARM JAYA LABORATORIES - Indonesia | HEXPHARM JAYA LABORATORIES - Indonesia | Obat Generik |
| 98 | Candesartan Cilexetil | Tablet | 16 mg | Blocand 16 | DKL1821024310B1 Tanggal Terbit 14-05-2019 | PYRIDAM FARMA TBK - Indonesia | PYRIDAM FARMA TBK - INDONESIA | Obat Generik |
| 99 | Candesartan Cilexetil | Tablet | 16 mg | Candesartan | GKL1502349710B1 Tanggal Terbit 22-03-2021 | BERNOFARM - INDONESIA | BERNOFARM - INDONESIA | Obat Generik |
| 100 | Candesartan Cilexetil | Tablet | 16 mg | Candefar 16 | DKL1731539310B1 Tanggal Terbit 29-03-2018 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
