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 |
|---|---|---|---|---|---|---|---|---|
| 281 | Pramipexole HCl Monohydrate | Tablet | 0,25 mg | Sifrol | DKI0252501510B1 Tanggal Terbit 02-09-2022 | BOEHRINGER INGELHEIM WEST GERMANY | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 282 | Pramipexole HCl Monohydrate | Tablet | 0,125 mg | Sifrol | DKI0252501510A1 Tanggal Terbit 02-09-2022 | BOEHRINGER INGELHEIM WEST GERMANY | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 283 | Pregabalin | Kapsul | 75 mg | Lyrica | DKI0590700601C1 Tanggal Terbit 28-03-2018 | PFIZER MANUFACTURING DEUTSCHLAND GMBH - GERMANY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 284 | Pregabalin | Kapsul | 50 mg | Lyrica | DKI0590700601B1 Tanggal Terbit 01-05-2020 | PFIZER MANUFACTURING DEUTSCHLAND GMBH - GERMANY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 285 | Pregabalin | Kapsul | 150 mg | Lyrica | DKI0590700601E1 Tanggal Terbit 28-03-2018 | PFIZER MANUFACTURING DEUTSCHLAND GMBH - GERMANY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 286 | Procaterol | Tablet | 50 mcg | Meptin | DKL8118700110A1 Tanggal Terbit 22-04-2021 | OTSUKA INDONESIA - INDONESIA pemberi lisensi OTSUKA PHARMACEUTICAL CO., LTD TOKYO JAPAN - Japan | OTSUKA INDONESIA - INDONESIA | Obat Komparator |
| 287 | Progesterone | Kapsul Lunak | 100 mg | Utrogestan | DKI1745900102A1 Tanggal Terbit 31-12-2018 | OLIC LIMITED - THAILAND | LAPI - INDONESIA | Obat Komparator |
| 288 | Progesterone | Kapsul Lunak | 200 mg | Utrogestan | DKI2045900202A1 Tanggal Terbit 29-07-2020 | OLIC LIMITED - THAILAND | SYDNA FARMA - INDONESIA | Obat Komparator |
| 289 | Pyridostigmine | Tablet Salut Gula | 60 mg | Mestinon | DKL2132209916A1 Tanggal Terbit 05-08-2021 | LABIANA PHARMACEUTICALS, SLU - SPAIN | MENARINI INDRIA LABORATORIES - INDONESIA | Obat Komparator |
| 290 | Quetiapine Fumarate | Tablet Lepas Lambat | 50 mg | Seroquel XR | DKI1333500614A1 Tanggal Terbit 01-08-2018 | ASTRAZENECA PHARMACEUTICAL COMPANY LTD. | 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 |
