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 |
|---|---|---|---|---|---|---|---|---|
| 31 | Apixaban | Tablet Salut Selaput | 5 mg | Eliquis | DKI2190702117B1 Tanggal Terbit 22-04-2021 | PFIZER IRELAND PHARMACEUTICALS - Ireland | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 32 | Aripiprazole | Orally Disintegrating Tablet | 15 mg | Abilify Discmelt | DKI1509700681B1 Tanggal Terbit 17-06-2021 | KOREA OTSUKA PHARMACEUTICAL - REPUBLIC OF KOREA | OTSUKA INDONESIA - INDONESIA | Obat Komparator |
| 33 | Aripiprazole | Orally Disintegrating Tablet | 10 mg | Abilify Discmelt | DKI1509700681A1 Tanggal Terbit 17-06-2021 | KOREA OTSUKA PHARMACEUTICAL - REPUBLIC OF KOREA | OTSUKA INDONESIA - INDONESIA | Obat Komparator |
| 34 | Aripiprazole | Tablet | 10 mg | Abilify | DKI0409700110A1 Tanggal Terbit 22-04-2020 | KOREA OTSUKA PHARMACEUTICAL - REPUBLIC OF KOREA | OTSUKA INDONESIA - INDONESIA | Obat Komparator |
| 35 | Aripiprazole | Tablet | 15 mg | Abilify | DKI0409700110B1 Tanggal Terbit 22-04-2020 | KOREA OTSUKA PHARMACEUTICAL - REPUBLIC OF KOREA | OTSUKA INDONESIA - INDONESIA | Obat Komparator |
| 36 | Aripiprazole | Tablet | 5 mg | Abilify | DKI0809700110DI Tanggal Terbit 28-03-2018 | KOREA OTSUKA PHARMACEUTICAL - REPUBLIC OF KOREA | OTSUKA INDONESIA - INDONESIA | Obat Komparator |
| 37 | Atorvastatin Calcium Trihydrate | Tablet Salut Selaput | 10 mg | Lipitor | DKI9790700217A1 Tanggal Terbit 03-06-2022 | PFIZER PHARMACEUTICALS LLC, VEGA BAJA, UNITED STATES OF AMERICA Dikemas dan Dirilis Oleh PFIZER MANUFACTURING DEUTSCHLAND GMBH, FREIBURG, FEDERAL REPUBLIC OF GERMANY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 38 | Atorvastatin Calcium Trihydrate | Tablet Salut Selaput | 80 mg | Lipitor | DKI1790700217D1 Tanggal Terbit 10-01-2021 | PFIZER PHARMACEUTICALS LLC, VEGA BAJA, UNITED STATES OF AMERICA Dikemas dan Dirilis Oleh PFIZER MANUFACTURING DEUTSCHLAND GMBH, FREIBURG, FEDERAL REPUBLIC OF GERMANY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 39 | Atorvastatin Calcium Trihydrate | Tablet Salut Selaput | 40 mg | Lipitor | DKI9790700217C1 Tanggal Terbit 07-06-2022 | PFIZER PHARMACEUTICALS LLC, VEGA BAJA, UNITED STATES OF AMERICA Dikemas dan Dirilis Oleh PFIZER MANUFACTURING DEUTSCHLAND GMBH, FREIBURG, FEDERAL REPUBLIC OF GERMANY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 40 | Atorvastatin Calcium Trihydrate | Tablet Salut Selaput | 20 mg | Lipitor | DKI9790700217B1 Tanggal Terbit 03-06-2022 | PFIZER PHARMACEUTICALS LLC, VEGA BAJA, UNITED STATES OF AMERICA Dikemas dan Dirilis Oleh PFIZER MANUFACTURING DEUTSCHLAND GMBH, FREIBURG, FEDERAL REPUBLIC OF GERMANY | PFIZER 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 |
|---|---|---|---|---|---|---|---|---|
| 511 | Ofloxacin | Tablet salut selaput | 400 mg | Ofloxacin | GKL9720921417B1 Tanggal Terbit 30-05-2018 | INDOFARMA - INDONESIA | INDOFARMA - INDONESIA | Obat Generik |
| 512 | Ofloxacin | Tablet Salut Selaput | 200 mg | Flotavid 200 | DKL0033302617A1 Tanggal Terbit 25-10-2021 | MERSIFARMA TIRMAKU MERCUSANA - Indonesia | MERSIFARMA TIRMAKU MERCUSANA - Indonesia | Obat Generik |
| 513 | Ofloxacin | Kaplet Salut Selaput | 400 mg | Rilox | DKL9621010809B1 Tanggal Terbit 18-06-2020 | PYRIDAM FARMA TBK - Indonesia | PYRIDAM FARMA TBK - INDONESIA | Obat Generik |
| 514 | Ofloxacin | Kaplet Salut Selaput | 400 mg | Grafloxin | DKL0131107809A1 Tanggal Terbit 9-05-2018 | GRAHA FARMA - INDONESIA | GRAHA FARMA - INDONESIA | Obat Generik |
| 515 | Ofloxacin | Tablet salut selaput | 400 mg | Ofloxacin | GKL0433510217B1 Tanggal Terbit 24-06-2019 | ETERCON PHARMA - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 516 | Olanzapine | Tablet salut selaput | 5 mg | Onzapin | DKL1705518217A1 Tanggal Terbit 15-02-2019 | ACTAVIS LTD. - MALTA | ACTAVIS - INDONESIA | Obat Generik |
| 517 | Olanzapine | Tablet Salut Selaput | 11 mg | Remital 10 | DKL1021639417A1 Tanggal Terbit 21-02-2022 | PHAROS INDONESIA - INDONESIA | PHAROS INDONESIA - Indonesia | Obat Generik |
| 518 | Olanzapine | Tablet salut selaput | 10 mg | Zypin | DKL2143501817B1 Tanggal Terbit 01-06-2021 | AMAROX PHARMA GLOBAL - INDONESIA | AMAROX PHARMA GLOBAL - INDONESIA | Obat Generik |
| 519 | Olanzapine | Tablet Salut Selaput | 10 mg | Olaz | DKL2132722017A1 Tanggal Terbit 11-09-2021 | YARINDO FARMATAMA - Indonesia | YARINDO FARMATAMA - INDONESIA | Obat Generik |
| 520 | Omeprazole | Kapsul | 20 mg | Pumpitor | DKL1022248644A1 Tanggal terbit 13-01-2021 | CAPRIFARMINDO LABORATORIES - INDONESIA | SANBE FARMA - INDONESIA | Obat Generik |
