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 |
|---|---|---|---|---|---|---|---|---|
| 371 | Vildagliptin/ Metformin HCl | Tablet Salut Selaput | 50 mg/ 500 mg | Galvusmet | DKL1930413117A1 Tanggal Terbit 18-06-2019 | NOVARTIS INDONESIA - INDONESIA | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 372 | Vildagliptin/ Metformin HCl | Tablet Salut Selaput | 50 mg/ 850 mg | Galvusmet | DKL1930413117B1 Tanggal Terbit 18-06-2019 | NOVARTIS INDONESIA - INDONESIA | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 373 | Voriconazole | Tablet Salut Selaput | 200 mg | Vfend | DKI2054201017A1 Tanggal Terbit 17-02-2020 | PFIZER ITALIA S.R.L - ITALY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 374 | Zolpidem Tartrate | Tablet Salut Selaput | 10 mg | Stilnox | DPL1421206017A1 Tanggal Terbit 28-02-2019 | AVENTIS PHARMA - INDONESIA | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 375 | Zonisamide | Tablet Salut Selaput | 100 mg | Zonegran | DKI1524400317A1 Tanggal Terbit 02-01-2020 | BORA PHARM CO. LTD - TAIWAN | EISAI 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 |
|---|---|---|---|---|---|---|---|---|
| 71 | Metoprolol | Tablet | (Metoprolol tartrate) 50 mg; 100 mg | Betaloc | Malaysia, Australia | Aztrazeneca Pharmaceutical Co. Ltd, China (MY) | Astrazeneca | - |
| 72 | Metoprolol | Tablet pelepasan lambat | (Metoprolol succinate) 95 mg | Betazok | Philippines | Astrazeneca AB, Sweden | Aztrazeneca Pharmaceuticals (Phils.) Inc | - |
| 73 | Metronidazole | Kapsul | 250 mg; 375 mg; 500 mg | Flagyl | USA | - | Pfizer Inc | - |
| 74 | Metronidazole | Tablet | 400 mg | Flagyl | Australia | - | Sanovi Aventis | - |
| 75 | Minocycline | Tablet lepas lambat | EQ 115 mg base | Solodyn | USA | - | BAUSCH HEALTH US LLC | - |
| 76 | Minocycline | Kapsul | 50 mg; 100 mg | Minocin | USA | - | BAUSCH HEALTH US LLC | - |
| 77 | Mirtazapine | Tablet | 30 mg; 15 mg | Remeron Sol Tab | Malaysia | - | Merck Sharp & Dohme Pharma - Malaysia | - |
| 78 | Molnupiravir | Kapsul | 200 mg | Lagevrio | Malaysia; UK | Patheon Inc, Canada (MY); Merck Sharp & Dohme BV, Netherland (UK) | Merck Sharp & Dohme (Malaysia) Sdn Bhd (MY); Merck Sharp & Dohme (UK) Limited (UK) | - |
| 79 | Nateglinide | Tablet salut selaput | 120 mg | Starlix | Germany | Germany | Novartis Europharm Limited | - |
| 80 | Nevirapine | Tablet | 200 mg | Viramune | USA | - | Boehringer Ingelheim | - |
LIST OF GENERIC DRUGS THAT HAVE MEET THE BIOECIVALENCE CRITERIA IN 2022
| No | ZAT AKTIF | BENTUK SEDIAAN | KEKUATAN | NAMA DAGANG | NIE | PRODUSEN | PENDAFTAR | STATUS |
|---|---|---|---|---|---|---|---|---|
| 131 | Cefixime Trihydrate | Kaplet Salut Selaput | 200 mg | Ceptik 200 | DKL0817623609A1 Tanggal Terbit 16-08-2022 | INTERBAT - Indonesia | INTERBAT - Indonesia | Obat Generik |
| 132 | Cefixime Trihydrate | Sirup Kering | 100 mg/5 mL | Cefarox | DKL0435302738A1 Tanggal Terbit 22-06-2020 | GRACIA PHARMINDO - INDONESIA | GRACIA PHARMINDO - INDONESIA | Obat Generik |
| 133 | Cefixime Trihydrate | Sirup Kering | 100 mg/5 mL | Cefila | DKL0813313938A1 Tanggal Terbit 28-08-2020 | LAPI LABORATORIES - INDONESIA | LAPI LABORATORIES - INDONESIA | Obat Generik |
| 134 | Cefixime Trihydrate | Sirup Kering | 100 mg/5 mL | Maxpro | DKL9815613138A1 Tanggal Terbit 19-07-2020 | MEPROFARM - INDONESIA | MEPROFARM - INDONESIA | Obat Generik |
| 135 | Cefixime Trihydrate | Sirup Kering | 100 mg/5 mL | Anfix | DKL0913705109A1 Tanggal Terbit 22-04-2021 | DARYA VARIA LABORATORIA - INDONESIA | MAHAKAM BETA FARMA - INDONESIA | Obat Generik |
| 136 | Cefixime Trihydrate | Sirup Kering | 100 mg/5 mL | Tocef | DKL9602322838A1 Tanggal Terbit 16-02-2021 | BERNOFARM - INDONESIA | BERNOFARM - INDONESIA | Obat Generik |
| 137 | Cefixime Trihydrate | Sirup Kering | 100 mg/5 mL | Ceptik | DKL9517611038A1 Tanggal Terbit 21-07-2022 | INTERBAT - Indonesia | INTERBAT - Indonesia | Obat Generik |
| 138 | Cefixime Trihydrate | Sirup Kering | 100 mg/5 mL | Starcef | DKL9505014838A1 Tanggal Terbit 07-06-2022 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 139 | Cefixime Trihydrate | Sirup Kering | 100 mg/5 mL | Profim | DKL2233217538A1 Tanggal Terbit 04-03-2022 | PROMEDRAHARDJO FARMASI INDUSTRI - Indonesia | PROMEDRAHARDJO FARMASI INDUSTRI - INDONESIA | Obat Generik |
| 140 | Cefixime Trihydrate | Sirup Kering | 100 mg/5 mL | Cefixime Trihydrate | GKL1340701738A1 Tanggal Terbit 06-12-2021 | PHARMA LABORATORIES - Indonesia | PHARMA LABORATORIES - Indonesia | Obat Generik |
