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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|---|
| 31 | Amiodarone Hydrochloride | Tablet | 200 mg | Tiaryt | DKL9531510310A1 Tanggal Terbit 23-05-2019 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 32 | Amiodarone Hydrochloride | Tablet | 200 mg | Kendaron | DKL0004515410A1 Tanggal Terbit 09-09-2020 | DARYA VARIA LABORATORIA TBK PLANT CITEUREUP - INDONESIA | DARYA VARIA LABORATORIA - INDONESIA | Obat Generik |
| 33 | Amiodarone Hydrochloride | Tablet | 200 mg | Amiodarone Hydrochloride | GKL1833542510A1 Tanggal Terbit 11-01-2019 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 34 | Amitriptyline hydrochloride | Tablet Salut Selaput | 25 mg | Amitriptyline hydrochloride | GKL9832706817A1 Tanggal Terbit 14-02-2022 | YARINDO FARMATAMA - Indonesia | YARINDO FARMATAMA - INDONESIA | Obat Generik |
| 35 | Amlodipine | Tablet | 10 mg | Amlodipine besylate | GKL2144402510A1 Tanggal Terbit 24-07-2022 | KIMIA FARMA Tbk. - Indonesia | KIMIA FARMA Tbk. - Indonesia | Obat Generik |
| 36 | Amlodipine | Kaplet | 10 mg | Cardisan 10 | DKL0822244610B1 Tanggal Terbit 15-06-2022 | SANBE FARMA - INDONESIA | SANBE FARMA (UNIT 1) - Indonesia | Obat Generik |
| 37 | Anastrozole | Tablet Salut Selaput | 1 mg | Sterazol | DKI2035401217A1 Tanggal Terbit 01-05-2020 | INTAS PHARMACEUTICAL LTD. - INDIA | NUFARINDO - INDONESIA | Obat Generik |
| 38 | Anastrozole | Tablet Salut Selaput | 1 mg | Forinaz | DKI2249100317A1 Tanggal Terbit 21-09-2022 | CADILA HEALTHCARE LIMITED - India | MEGA LIFESCIENCES INDONESIA - Indonesia | Obat Generik |
| 39 | Anastrozole | Tablet Salut Selaput | 1 mg | ATZ | DKI1943400317A1 Tanggal Terbit 12-10-2019 | SYNTHON HISPANIA, S.L. - Spain | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 40 | Anastrozole | Tablet Salut Selaput | 1 mg | Anzonat | DKI2049500517A1 Tanggal Terbit 14-04-2020 | NATCO PHARMA LIMITED - INDIA | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Generik |
