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 |
|---|---|---|---|---|---|---|---|---|
| 11 | Cefpodoxime | Suspensi | 100 mg/5 mL | Banadoz | USA | - | Aurobindo Pharma Ltd | - |
| 12 | Cefpodoxime | Tablet | 200 mg | Cefpdoxime Proxetil | USA; Australia | - | Sandoz Inc | - |
| 13 | Ciprofloxacin | Tablet | 500 mg | Ciprobay | Singapore | Bayer AG (Germany) dan Bayer Healthcare Manufacturing (S.r.l) Italy | Bayer South East Asia, Pte Ltd | - |
| 14 | Ciprofloxacin | Tablet | 500 mg | Ciproxin | Belgium | Bayer SA, Belgium | Bayer SA, Belgium | - |
| 15 | Ciprofloxacin | Tablet pelepasan lambat | 1000 mg | Ciprobay | Philippines | Bayer Pharma AG Germany | Bayer Co. (Malaysia) Sdn Bhd | - |
| 16 | Clonazepam | Tablet | 2 mg | Rivotril (DE, AT, NL, ES); Klonopin (US) | Germany, Austria, Netherland, Sppain | - | CHEPLAPHARM ARZNEIMITTEL GMBH | - |
| 17 | Clozapine | Tablet | 25 mg | Leponex | Philippines | Novartis Saglik, Gida Ve Tarim Urunleri, San. Ve Tic. AS, Turkey | Mylan Philippines | - |
| 18 | Colchicine | Tablet | 0,5 mg | Colchicine Teva; Colchicine Sandoz | Netherland | Teva, Nederland; Sandoz, Netherland | Teva Nederland BV; Tio Farma, Netherland | - |
| 19 | Colchicine | Tablet | 0,6 mg | Colcrys | USA | - | Takeda Pharmaceuticals USA | - |
| 20 | Daclatasvir | Tablet | 30 mg; 60 mg | Daclatasvir | - | Mylan Laboratories Ltd (only the prequalified HP015/HP016 is acceptable as reference product) Sumber: WHO Recommended Comparator Product: Medicines for Hepatitis B and C | - | - |
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 |
