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 |
|---|---|---|---|---|---|---|---|---|
| 361 | Valaciclovir HCl | Tablet Salut Selaput | 500 mg | Valtrex | DKI1691601017A1 Tanggal Terbit 02-05-2020 | GLAXO WELLCOME SA - SPAIN | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 362 | Valganciclovir HCl | Tablet Salut Selaput | 496,3 mg | Valcyte | DKI1011600217A1 Tanggal Terbit 24-04-2020 | PATHEON INC - CANADA | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 363 | Valsartan | Tablet Salut Selaput | 80 mg | Diovan | DKI2197301217A1 Tanggal Terbit 11-10-2021 | SIEGFRIED BARBERA, S.L. - Spain | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 364 | Valsartan | Tablet Salut Selaput | 160 mg | Diovan | DKI2197301217B1 Tanggal Terbit 11-10-2021 | SIEGFRIED BARBERA, S.L. - Spain | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 365 | Vardenafil HCl Trihydrate | Tablet Salut Selaput | 10 mg | Levitra | DKI0351601917B1 Tanggal Terbit 28-12-2018 | BAYER PHARMA AG, LEVERKUSEN - GERMANY | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 366 | Vardenafil HCl Trihydrate | Tablet Salut Selaput | 20 mg | Levitra | DKI0351601917C1 Tanggal Terbit 28-12-2018 | BAYER PHARMA AG, LEVERKUSEN - GERMANY | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 367 | Venlafaxine HCl | Kapsul Lepas Lambat | 75 mg | Efexor XR | DKI1191400603A1 Tanggal Terbit 27-01-2021 | PFIZER IRELAND PHARMACEUTICALS - IRELAND | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 368 | Verapamil | Tablet Salut Selaput | 80 mg | Isoptin | DKL0200202717A1 Tanggal Terbit 15-07-2019 | ABBOTT INDONESIA-INDONESIA DENGAN LISENSI ABBOTT LABORATORIES - UNITED STATES OF AMERICA | ABBOTT INDONESIA - INDONESIA | Obat Komparator |
| 369 | Verapamil | Kaplet Pelepasan Lambat | 240 mg | Isoptin SR | DKL1900207497A1 Tanggal Terbit 16-10-2019 | ABBOTT INDONESIA - INDONESIA | ABBOTT INDONESIA - INDONESIA | Obat Komparator |
| 370 | Vildagliptin | Tablet | 50 mg | Galvus | DKI1697300610A1 Tanggal Terbit 24-05-2022 | SIEGFRIED BARBERA, S.L. - Spain | NOVARTIS 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 |
|---|---|---|---|---|---|---|---|---|
| 91 | Pyrazinamide | Tablet | 500 mg | Pyrazinamide | USA | - | Akorn Inc | - |
| 92 | Pyrazinamide | Tablet | 500 mg | Zinamide | UK | - | Genus Pharmaceuticals Ltd | - |
| 93 | Repaglinide | Tablet | 0,5; 1 mg; 2 mg | NovoNorm | Malaysia, Philippines | Boehringer Ingelheim Pharma KG, Germany | Novo Nordisk | - |
| 94 | Ribavirin | Kapsul | 200 mg | Rebetol | USA | - | Merck Sharp & Dohme | - |
| 95 | Ribavirin | Tablet | 200 mg | Copegus | Malaysia | - | Pharma Corpia | - |
| 96 | Rifampicin | Kapsul | 300 mg; 150 mg | Rimactane | UK | - | Sandoz (Austria) | - |
| 97 | Rifampicin | Kapsul | 300 mg; 150 mg | Rifadin | Netherland | Sanofi SpA, Italy | Genzyme Europe BV | - |
| 98 | Rifampicin | Kapsul | 300 mg; 150 mg | Rifampicin | Netherland | - | Sandoz | - |
| 99 | Risperidone | Tablet | 1 mg | Risperdal | Australia, Malaysia, Philippines | Janssen Cilag SPA, Italy (MY, PH) | JANSSEN CILAG PTY LTD; Johnson & Johnson (MY, PH) | - |
| 100 | Risperidone | Tablet | 2 mg | Risperdal | Australia, Malaysia, Philippines | Janssen Cilag SPA, Italy (MY, PH) | JANSSEN CILAG PTY LTD; Johnson & Johnson (MY, PH)) | - |
LIST OF GENERIC DRUGS THAT HAVE MEET THE BIOECIVALENCE CRITERIA IN 2022
| No | ZAT AKTIF | BENTUK SEDIAAN | KEKUATAN | NAMA DAGANG | NIE | PRODUSEN | PENDAFTAR | STATUS |
|---|---|---|---|---|---|---|---|---|
| 81 | Bicalutamide | Tablet Salut Selaput | 50 mg | Promod 50 | DKI1935400617A1 Tanggal Terbit 12-10-2019 | INTAS PHARMACEUTICAL LTD. - INDIA | MERSIFARMA TIRMAKU MERCUSANA - INDONESIA | Obat Generik |
| 82 | Bicalutamide | Tablet Salut Selaput | 150 mg | Biluron 150 | DKI1943400517B1 Tanggal Terbit 06-12-2019 | SYNTHON HISPANIA, S.L. - Spain | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 83 | Bicalutamide | Tablet Salut Selaput | 50 mg | Bicastra | DKI1618600817A1 Tanggal Terbit 23-03-2021 | HETERO LABS LIMITED - INDIA | FERRON PAR PHARMACEUTICALS - INDONESIA | Obat Generik |
| 84 | Bicalutamide | Tablet Salut Selaput | 150 mg | Calutami 150 | DKI1884400517B1 Tanggal Terbit 21-01-2019 | CHONG KUN DANG PHARMACEUTICAL - REPUBLIC OF KOREA | OTTO PHARMACEUTICAL INDUSTRIES - INDONESIA | Obat Generik |
| 85 | Bicalutamide | Tablet Salut Selaput | 50 mg | Biluron 50 | DKI1943400517A1 Tanggal Terbit 06-12-2019 | SYNTHON HISPANIA, S.L. - Spain | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 86 | Bisoprolol fumarate | Tablet salut selaput | 5 mg | Tencard | DKL2144403617B1 Tanggal Terbit 01-11-2021 | KIMIA FARMA Tbk. - Indonesia | KIMIA FARMA Tbk. - Indonesia | Obat Generik |
| 87 | Bisoprolol Fumarate | Tablet Salut Selaput | 5 mg | Selbix | DKL1702354617A1 Tanggal Terbit 17-10-2018 | BERNOFARM - INDONESIA | BERNOFARM - INDONESIA | Obat Generik |
| 88 | Bisoprolol Fumarate | Tablet Salut Selaput | 5 mg | Konblobet | DKL2013028017A1 Tanggal Terbit 18-08-2021 | KONIMEX - INDONESIA | KONIMEX - INDONESIA | Obat Generik |
| 89 | Bisoprolol Fumarate | Tablet Salut Selaput | 5 mg | Miniten | DKL13025025117A1 Tanggal Terbit 14-03-2018 | DIPA PHARMALAB INTERSAINS - INDONESIA | DIPA PHARMALAB INTERSAINS - INDONESIA | Obat Generik |
| 90 | Bisoprolol Fumarate | Tablet Salut Selaput | 5 mg | Bisoprolol Fumarate | GKL0633516517A1 Tanggal Terbit 21-03-2019 | ETERCON PHARMA - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
