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 |
|---|---|---|---|---|---|---|---|---|
| 61 | Captopril | Tablet | 50 mg | Captopril | GKL9705023010C1 Tanggal Terbit 01-11-2018 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Komparator |
| 62 | Carbamazepine | Tablet | 200 mg | Tegretol | DKL9930410310A1 Tanggal Terbit 08-06-2021 | NOVARTIS INDONESIA - INDONESIA | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 63 | Cefditoren Pivoxil | Tablet Salut Selaput | 200 mg | Meiact 200 | DKI0665600217A1 Tanggal Terbit 23-12-2020 | MEIJI PHARMA SPAIN, S.A - Spain | MEIJI INDONESIAN PHARMACEUTICAL INDUSTRIES - Indonesia | Obat Komparator |
| 64 | Cefixime Trihydrate | Kapsul | 100 mg | Cefspan | DKL9211616501B1 Tanggal Terbit 27-01-2021 | DANKOS FARMA - INDONESIA LISENSI DARI OTSUKA CHEMICAL CO LTD - JAPAN | KALBE FARMA - INDONESIA | Obat Komparator |
| 65 | Cefixime Trihydrate | Kaplet Salut Selaput | 200 mg | Cefspan | DKL0311636509A1 Tanggal Terbit 21-07-2019 | DANKOS FARMA LISENSI ASTELLAS PHARMA INC., - JAPAN | KALBE FARMA - INDONESIA | Obat Komparator |
| 66 | Cefixime Trihydrate | Sirup Kering | 120,67 mg | Cefspan | DKL9211616738A1 Tanggal Terbit 05-07-2020 | DANKOS FARMA LISENSI OTSUKA CHEMICAL CO., LTD. - JAPAN | KALBE FARMA - INDONESIA | Obat Komparator |
| 67 | Cefuroxime Axetil | Tablet Salut Selaput | 250 mg | Zinnat | DKI9775700517B1 Tanggal Terbit 22-03-2022 | GLAXO OPERATIONS UK LTD - ENGLAND | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 68 | Cefuroxime Axetil | Tablet Salut Selaput | 500 mg | Zinnat | DKI9775700517C1 Tanggal Terbit 22-03-2022 | GLAXO WELLCOME AUSTRALIA PTY LTD, AUSTRALIA | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 69 | Celecoxib | Kapsul | 200 mg | Celebrex | DKL2019809701B1 Tanggal Terbit 24-02-2020 | PFIZER PHARMACEUTICALS LLC - USA | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 70 | Celecoxib | Kapsul | 100 mg | Celebrex | DKL1919809701A1 Tanggal Terbit 24-02-2020 | PFIZER PHARMACEUTICALS LLC - USA | 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 |
