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 |
|---|---|---|---|---|---|---|---|---|
| 271 | Phenytoin | Kapsul Lepas Lambat | 100 mg | Dilantin | DKL7219807301A1 Tanggal Terbit 20-09-2020 | PFIZER INDONESIA - INDONESIA | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 272 | Pioglitazone HCl | Tablet | 30 mg | Actos | DKL0125102110B1 Tanggal Terbit 07-08-2020 | TAKEDA INDONESIA - INDONESIA DENGAN LISENSI TAKEDA PHARMACEUTICAL COMPANY, JAPAN | TAKEDA INDONESIA - INDONESIA | Obat Komparator |
| 273 | Pioglitazone HCl | Tablet | 15 mg | Actos | DKL0125102110A1 Tanggal Terbit 07-08-2020 | TAKEDA INDONESIA - INDONESIA DENGAN LISENSI TAKEDA PHARMACEUTICAL COMPANY, JAPAN | TAKEDA INDONESIA - INDONESIA | Obat Komparator |
| 274 | Pioglitazone HCl/ Metformin HCl | Kaplet | 15 mg/850 mg | Actosmet | DKL1325103517A1 Tanggal Terbit 01-05-2020 | TAKEDA INDONESIA - INDONESIA | TAKEDA INDONESIA - INDONESIA | Obat Komparator |
| 275 | Pipemidic acid | Tablet Salut Selaput | 400 mg | Urixin | DKL8300200417B1 Tanggal Terbit 04-01-2018 | ABBOTT INDONESIA - INDONESIA | ABBOTT INDONESIA - INDONESIA | Obat Komparator |
| 276 | Piroxicam | Tablet Cepat Larut | 20 mg | Feldene Flash | DKI9584800681A1 Tanggal Terbit 19-03-2019 | HAUPT PHARMA LIVRON - FRANCE | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 277 | Pitavastatin Calcium | Tablet Salut Selaput | 2 mg | Livalo | DKL1925202817A1 Tanggal Terbit 28-02-2019 | TANABE INDONESIA - INDONESIA | TANABE INDONESIA - INDONESIA | Obat Komparator |
| 278 | Pitavastatin Calcium | Tablet Salut Selaput | 4 mg | Livalo | DKL1925202817B1 Tanggal Terbit 28-02-2019 | TANABE INDONESIA - INDONESIA | TANABE INDONESIA - INDONESIA | Obat Komparator |
| 279 | Pramipexole | Tablet Lepas Lambat | 0,375 mg | Sifrol ER | DKI2124200314A1 Tanggal Terbit 04-08-2021 | ROTTENDORF PHARMA GMBH - Federal Republic of Germany | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 280 | Pramipexole | Tablet Lepas Lambat | 0,75 mg | Sifrol ER | DKI2124200314B1 Tanggal Terbit 04-08-2021 | ROTTENDORF PHARMA GMBH - Federal Republic of Germany | BOEHRINGER INGELHEIM 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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
