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 |
|---|---|---|---|---|---|---|---|---|
| 341 | Telmisartan/ Amlodipin | Tablet | 80/ 10 mg | Twynsta | DKI2124200210D1 Tanggal Terbit 27-01-2021 | CIPLA LIMITED - INDIA | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 342 | Telmisartan/ Hydrochlorothiazide | Tablet | 80/ 12,5 mg | Micardis Plus | DKI2055200110A1 Tanggal Terbit 15-04-2020 | BOEHRINGER INGELHEIM ELLAS A.E - GREECE | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 343 | Telmisartan/ Hydrochlorothiazide | Tablet | 80/ 12,5 mg | Micardis Plus | DKI2055200110B1 Tanggal Terbit 15-04-2020 | BOEHRINGER INGELHEIM ELLAS A.E - GREECE | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 344 | Temozolomide | Kapsul | 20 mg | Temodal | DKI0287100901B1 Tanggal Terbit 18-08-2021 | ORION CORPORATION - FINLAND | ORGANON PHARMA INDONESIA TBK - INDONESIA | Obat Komparator |
| 345 | Temozolomide | Kapsul | 100 mg | Temodal | DKI0287100901C1 Tanggal Terbit 18-08-2021 | ORION CORPORATION - FINLAND | ORGANON PHARMA INDONESIA TBK - INDONESIA | Obat Komparator |
| 346 | Tenofovir Alafenamide Fumarate | Tablet Salut Selaput | 30 mg | Vemlidy | DKI1844200417A1 Tanggal Terbit 24-01-2019 | PATHEON INC - CANADA | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Komparator |
| 347 | Terazosin | Tablet | 2 mg | Hytrin | DKI9975500310B1 Tanggal Terbit 14-09-2018 | AESICA QUEENBOROUGH LTD - INGGRIS | ABBOTT INDONESIA - INDONESIA | Obat Komparator |
| 348 | Terazosin | Tablet | 1 mg | Hytrin | DKI9975500310A1 Tanggal Terbit 14-09-2018 | AESICA QUEENBOROUGH LTD - INGGRIS | ABBOTT INDONESIA - INDONESIA | Obat Komparator |
| 349 | Terbutaline Sulfate | Serbuk inhaler | 0,5 mg/dosis | Bricasma Turbuhaler | DKI1851303467A1 Tanggal Terbit 24-02-2020 | ASTRAZENECA PHARMACEUTICALS - SWEDEN | ASTRAZENECA - INDONESIA | Obat Komparator |
| 350 | Thiamazole | Tablet Salut Selaput | 5 mg | Thyrozol | DKI0063401417A2 Tanggal Terbit 19-04-2022 | MERCK HEALTHCARE KGAA - FEDERAL REPUBLIC OF GERMANY | MERCK TBK - 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 |
|---|---|---|---|---|---|---|---|---|
| 71 | Azithromycin Dihydrate | Kaplet Salut Selaput | 500 mg | Zithrax | DKL9604413909A1 Tanggal Terbit 31-12-2018 | DANKOS FARMA - INDONESIA | DANKOS FARMA - INDONESIA | Obat Generik |
| 72 | Azithromycin Dihydrate | Kaplet Salut Selaput | 500 mg | Zarom 500 | DKL1621022509A1 Tanggal Terbit 14-08-2017 | PYRIDAM FARMA TBK - Indonesia | PYRIDAM FARMA TBK - INDONESIA | Obat Generik |
| 73 | Azithromycin Dihydrate | Kaplet Salut Selaput | 500 mg | Zitrolin | DKL1218826409A1 Tanggal Terbit 06-07-2022 | OTTO PHARMACEUTICALS INDUSTRIES - INDONESIA | OTTO PHARMACEUTICAL INDUSTRIES - INDONESIA | Obat Generik |
| 74 | Azithromycin Dihydrate | Kapsul | 250 mg | Mezatrin 250 | DKL9522216101A1 Tanggal Terbit 15-04-2020 | CAPRIFARMINDO LABORATORIES - INDONESIA | SANBE FARMA - INDONESIA | Obat Generik |
| 75 | Azithromycin Dihydrate | Kaplet Salut Selaput | 500 mg | Azomax 500 | DKL9505017109A1 Tanggal Terbit 28-08-2018 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 76 | Azithromycin Dihydrate | Tablet salut selaput | 500 mg | Azivol | DKL1333530744A1 Tanggal Terbit 14-04-2022 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 77 | Azithromycin Dihydrate | Kaplet Salut Selaput | 500 mg | Trozin 500 | DKL0922720409B1 Tanggal Terbit 25-01-2022 | TEMPO SCAN PACIFIC TBK - INDONESIA | TEMPO SCAN PACIFIC TBK - INDONESIA | Obat Generik |
| 78 | Azithromycin Dihydrate | Kaplet Salut Selaput | 524 mg | Zistic | DKL9502321309A1 Tanggal Terbit 13-08-2019 | BERNOFARM - INDONESIA | BERNOFARM - INDONESIA | Obat Generik |
| 79 | Bicalutamide | Tablet Salut Selaput | 50 mg | Calutami 50 | DKI1884400517A1 Tanggal Terbit 21-01-2019 | CHONG KUN DANG PHARMACEUTICAL - REPUBLIC OF KOREA | OTTO PHARMACEUTICAL INDUSTRIES - INDONESIA | Obat Generik |
| 80 | Bicalutamide | Tablet Salut Selaput | 50 mg | Promod 50 | DKI1935400617A1 Tanggal Terbit 12-10-2019 | INTAS PHARMACEUTICAL LTD. - INDIA | MERSIFARMA TIRMAKU MERCUSANA - INDONESIA | Obat Generik |
