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 |
|---|---|---|---|---|---|---|---|---|
| 251 | Ofloxacin | Tablet salut selaput | 400 mg | Tarivid | DKL9311608317C1 Tanggal Terbit 12-09-2019 | KALBE FARMA - INDONESIA, UNDER LICENSE OF DAIICHI SANKYO CO., LTD. - JAPAN | KALBE FARMA - INDONESIA | Obat Komparator |
| 252 | Ofloxacin | Tablet salut selaput | 200 mg | Tarivid | DKL8811608317B1 Tanggal Terbit 10-09-2019 | KALBE FARMA - INDONESIA, UNDER LICENSE OF DAIICHI SANKYO CO., LTD. - JAPAN | KALBE FARMA - INDONESIA | Obat Komparator |
| 253 | Olanzapine | Tablet salut selaput | 5 mg | Zyprexa | DKI1973401917A1 Tanggal Terbit 09-07-2021 | LILLY SA - SPANYOL | PYRIDAM FARMA - INDONESIA | Obat Komparator |
| 254 | Olanzapine | Tablet salut selaput | 10 mg | Zyprexa | DKI1973401917B1 Tanggal Terbit 09-07-2021 | LILLY SA - SPANYOL | PYRIDAM FARMA - INDONESIA | Obat Komparator |
| 255 | Olanzapine | Tablet orodispersible | 5 mg | Zyprexa Zydis | DKI1973401681A1 Tanggal Terbit 20-04-2021 | CATALENT UK SWINDON ZYDIS LIMITED - UNITED KINGDOM | PYRIDAM FARMA - INDONESIA | Obat Komparator |
| 256 | Olanzapine | Tablet orodispersible | 10 mg | Zyprexa Zydis | DKI1973401681B1 Tanggal Terbit 21-04-2021 | CATALENT UK SWINDON ZYDIS LIMITED - UNITED KINGDOM | PYRIDAM FARMA - INDONESIA | Obat Komparator |
| 257 | Olmesartan | Tablet Salut Selaput | 40 mg | Olmetec | DKI1890701717B1 Tanggal Terbit 15-07-2019 | DAICHI SANKYO EUROPE GMBH - GERMANY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 258 | Olmesartan | Tablet Salut Selaput | 20 mg | Olmetec | DKI1890701717A1 Tanggal Terbit 04-11-2019 | DAICHI SANKYO EUROPE GMBH - GERMANY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 259 | Omeprazole | Kapsul | 20 mg | Losec | DKI9551300701A1 Tanggal Terbit 18-09-2019 | ASTRAZENECA AB - SWEDIA | ASTRAZENECA - INDONESIA | Obat Komparator |
| 260 | Oseltamivir | Kapsul | 98,5 mg | Tamiflu | DKI2157510401A1 Tanggal Terbit 12-07-2022 | DELPHARM MILANO S.R.L - ITALY | MENARINI INDRIA LABORATORIES - Indonesia NDONESIA | 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 |
|---|---|---|---|---|---|---|---|---|
| 551 | Pregabalin | Kapsul | 150 mg | Gamalix 150 | DKL2109226401A1 Tanggal Terbit 06-12-2021 | IFARS PHARMACEUTICAL LABORATORIES - INDONESIA | IFARS PHARMACEUTICAL LABORATORIES - INDONESIA | Obat Generik |
| 552 | Pregabalin | Kapsul | 150 mg | Pregabalin | GKL1812429301A1 Tanggal Terbit 22-09-2019 | KIMIA FARMA - INDONESIA | KIMIA FARMA - INDONESIA | Obat Generik |
| 553 | Pregabalin | Kapsul | 150 mg | Labalin | DKL1813320601B1 Tanggal Terbit 23-05-2019 | LAPI - INDONESIA | LAPI - INDONESIA | Obat Generik |
| 554 | Pregabalin | Kapsul | 150 mg | Provelyn | DKL1211642401B1 Tanggal Terbit 17-01-2022 | DANKOS FARMA - INDONESIA | KALBE FARMA - INDONESIA | Obat Generik |
| 555 | Pregabalin | Kapsul | 150 mg | Neufar | DKL1831541101B1 Tanggal Terbit 31-12-2018 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 556 | Pregabalin | Kapsul | 150 mg | Nomathic | DKL1704526201B1 Tanggal Terbit 6-05-2019 | DARYA VARIA LABORATORIA - INDONESIA | DARYA VARIA LABORATORIA - INDONESIA | Obat Generik |
| 557 | Pregabalin | Kapsul | 75 mg | Noleptic | DKL2019934401A1 Tanggal Terbit 22-06-2020 | PHAPROS - INDONESIA | PHAPROS - INDONESIA | Obat Generik |
| 558 | Pregabalin | Kapsul | 150 mg | Pregex | DKL2043500801C1 Tanggal Terbit 10-02-2020 | AMAROX PHARMA GLOBAL - INDONESIA | AMAROX PHARMA GLOBAL - INDONESIA | Obat Generik |
| 559 | Pregabalin | Kapsul | 150 mg | Pregabalin | GKL1909324401B1 Tanggal Terbit 12-11-2020 | IKAPHARMINDO PUTRAMAS - INDONESIA | IKAPHARMINDO PUTRAMAS - INDONESIA | Obat Generik |
| 560 | Pregabalin | Kapsul | 150 mg | Nulyn-150 | DKL2043004701A1 Tanggal Terbit 23-12-2020 | NULAB PHARMACEUTICAL INDONESIA - INDONESIA | NULAB PHARMACEUTICAL INDONESIA | Obat Generik |
