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 |
|---|---|---|---|---|---|---|---|---|
| 301 | Risedronate Sodium | Tablet Salut Selaput | 35 mg | Actonel Once-a-week | DKI2153900417A1 Tanggal Terbit 28-03-2021 | BALKANPHARMA-DUPNITSA AD - BULGARIA | PYRIDAM FARMA - INDONESIA | Obat Komparator |
| 302 | Risedronate Sodium | Tablet Salut Selaput | 150 mg | Actonel Once-a-month | DKI2153900317A1 Tanggal Terbit 28-03-2021 | BALKANPHARMA-DUPNITSA AD - BULGARIA | PYRIDAM FARMA - INDONESIA | Obat Komparator |
| 303 | Rivaroxaban (micronizad) | Tablet Salut Selaput | 10 mg | Xarelto | DKI0951602517A1 Tanggal Terbit 28-02-2019 | BAYER PHARMA AG, LEVERKUSEN - GERMANY | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 304 | Rivaroxaban (micronizad) | Tablet Salut Selaput | 15 mg | Xarelto | DKI1251602517B1 Tanggal Terbit 11-01-2022 | BAYER PHARMA AG, LEVERKUSEN - GERMANY | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 305 | Rivaroxaban (micronizad) | Tablet Salut Selaput | 20 mg | Xarelto | DKI1251602517C1 Tanggal Terbit 11-01-2022 | BAYER PHARMA AG, LEVERKUSEN - GERMANY | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 306 | Ropinirole HCl | Tablet Lepas Lambat | 2 mg | Requip PD 24 hour | DKI1291600614A1 Tanggal Terbit 16-06-2022 | GLAXO WELLCOME SA - SPAIN | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 307 | Ropinirole HCl | Tablet Lepas Lambat | 4 mg | Requip PD 24 hour | DKI1291600614B1 Tanggal Terbit 16-06-2022 | GLAXO WELLCOME SA - SPAIN | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 308 | Ropinirole HCl | Tablet Lepas Lambat | 8 mg | Requip PD 24 hour | DKI1291600614C1 Tanggal Terbit 16-06-2022 | GLAXO WELLCOME SA - SPAIN | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 309 | Rosuvastatin Calcium | Tablet Salut Selaput | 40 mg | Crestor | DKI1435300817D1 Tanggal Terbit 19-10-2018 | IPR PHARMACEUTICAL INC-UNITED KINGDOM | ASTRAZENECA - INDONESIA | Obat Komparator |
| 310 | Rosuvastatin Calcium | Tablet salut selaput | 20 mg | Crestor | DKI1435300817C1 Tanggal Terbit 19-10-2018 | IPR PHARMACEUTICAL INC-UNITED KINGDOM | ASTRAZENECA - 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 |
|---|---|---|---|---|---|---|---|---|
| 1 | Acetylsalicylic Acid | Tablet | 300 mg | Bayer Aspirin | Filipina | Bayer Bitterfeld GmbH OT Greppin – Germany] | Bayer Phils., Inc | - |
| 2 | Alendronate sodium | Tablet | 70 mg | Fosamax | USA | - | Merck And Co Inc | - |
| 3 | Amitriptylline | Tablet | 10 mg; 25 mg;75 mg | Tryptizol | Italy | - | (Merck Sharp & Dohme, Lda. Atau Frosst Iberica, S.A.) Italy | - |
| 4 | Amitriptylline | Tablet | 10 mg; 50 mg; 75 mg; 100 mg; 150 mg | Amitriptylline Hydrochloride | USA | - | Sandoz Inc | - |
| 5 | Amoxicillin | Kapsul | 500 mg | Amoxil | Singapore | Smithkline Beecham Limited (UK); Glaxo Wellcome Production (FR) | Glaxosmithkline Pte Ltd | - |
| 6 | Artemether (kombinasi dengan Lumefantrine) | Tablet | 20 mg/120 mg | Riamet | Malaysia | - | Novartis Corporation (Malaysia) Sdn. Bhd | - |
| 7 | Artesunate | - | - | Arsumax Arsuamoon | - | - | Sanofi F Guilin Pharmaceuticals (China) | - |
| 8 | Atenolol | Tablet | 100 mg | Tenormin | Malaysia | Astrazeneca UK Limited | Astrazeneca | - |
| 9 | Carvedilol | Tablet | 25 mg | Dilatrend | Malaysia | Delpharm Milano S.R.L, Italy | DKSH Malaysia SDN BHD | - |
| 10 | Cefdinir | Kapsul | 300 mg | Cefdinir | USA | - | Sandoz Inc | - |
LIST OF GENERIC DRUGS THAT HAVE MEET THE BIOECIVALENCE CRITERIA IN 2022
| No | ZAT AKTIF | BENTUK SEDIAAN | KEKUATAN | NAMA DAGANG | NIE | PRODUSEN | PENDAFTAR | STATUS |
|---|---|---|---|---|---|---|---|---|
| 521 | Omeprazole | Kapsul lepas tunda | 20 mg | Norsec | DKL9508003303A1 Tanggal Terbit 27-11-2018 | GUARDIAN PHARMATAMA - INDONESIA | GUARDIAN PHARMATAMA - INDONESIA | Obat Generik |
| 522 | Omeprazole | Kapsul lepas tunda | 20 mg | Omz | DKL1134609503A2 Tanggal Terbit 8-11-2018 | DEXA MEDICA - INDONESIA | FERRON PAR PHARMACEUTICALS - INDONESIA | Obat Generik |
| 523 | Omeprazole | Kapsul lepas tunda | 20 mg | Omed 20 | DKL1039200403A1 Tanggal Terbit 04-10-2022 | MEGA LIFESCIENCES INDONESIA - Indonesia | MEGA LIFESCIENCES INDONESIA - Indonesia | Obat Generik |
| 524 | Omeprazole Pellet | Kapsul lepas tunda | 0.085 | Ozid | DKL9904514403A1 Tanggal Terbit 28-08-2020 | DARYA VARIA LABORATORIA TBK PLANT CITEUREUP - INDONESIA | DARYA VARIA LABORATORIA - INDONESIA | Obat Generik |
| 525 | Omeprazole Pellet | Kapsul lepas tunda | 0.085 | Rindopump | DKL9832707203A1 Tanggal Terbit 14-01-2020 | YARINDO FARMATAMA - INDONESIA | YARINDO FARMATAMA - INDONESIA | Obat Generik |
| 526 | Ondansetron Hydrochloride Dihydrate | Tablet cepat larut | 10 mg | Ondane-8 | DKL1908026681B1 Tanggal Terbit 14-11-2020 | GUARDIAN PHARMATAMA - INDONESIA | GUARDIAN PHARMATAMA - INDONESIA | Obat Generik |
| 527 | Oseltamivir Phosphate | Kapsul | 98,527 mg | Fluvir | DKI2018603301A1 Tanggal Terbit 01-05-2020 | HETERO LABS LIMITED - INDIA | AMAROX PHARMA GLOBAL - INDONESIA | Obat Generik |
| 528 | Oseltamivir Phosphate | Kapsul | 98,527 mg | Nocovir 75 | DKI2054800901A1 Tanggal Terbit 13-01-2021 | MACLEODS PHARMACEUTICALS LIMITED - INDIA | SAMPHARINDO RETROVIRAL INDONESIA - INDONESIA | Obat Generik |
| 529 | Pantoprazole | Tablet salut enterik | 40 mg | Pepzol 40 | DKL1213706615B1 Tanggal Terbit 17-11-2021 | MAHAKAM BETA FARMA - INDONESIA | MAHAKAM BETA FARMA - INDONESIA | Obat Generik |
| 530 | Pantoprazole | Tablet salut enterik | 40 mg | Pantopump 40 | DKL1617627207A1 Tanggal Terbit 27-02-2021 | INTERBAT - INDONESIA | INTERBAT - INDONESIA | Obat Generik |
