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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
