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 |
|---|---|---|---|---|---|---|---|---|
| 11 | Allopurinol | Tablet | 100 mg | Zyloric | DKL9932004210A1 Tanggal Terbit 21-01-2019 | GLAXO WELLCOME INDONESIA - INDONESIA | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 12 | Alprazolam | Kaplet | 0,25 mg | Xanax | DPI1054200604A1 Tanggal Terbit 30-10-2020 | PFIZER ITALIA S.R.L - ITALY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 13 | Alprazolam | Kaplet | 0,5 mg | Xanax | DPI1054200604B1 Tanggal Terbit 30-10-2020 | PFIZER ITALIA S.R.L - ITALY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 14 | Alprazolam | Kaplet | 1 mg | Xanax | DPI1054200604C1 Tanggal Terbit 30-10-2020 | PFIZER ITALIA S.R.L - ITALY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 15 | Amiodarone | Tablet | 200 mg | Cordarone | DKL1421205810A1 Tanggal Terbit 21-10-2021 | AVENTIS PHARMA - INDONESIA | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 16 | Amlodipine Besilate | Tablet | 5 mg | Norvask | DKL9219803410A1 Tanggal Terbit 08-10-2018 | PFIZER INDONESIA - INDONESIA | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 17 | Amlodipine Besilate | Tablet | 10 mg | Norvask | DKL9619803410B1 Tanggal Terbit 08-10-2018 | PFIZER INDONESIA - INDONESIA | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 18 | Amlodipine Besilate/ Valsartan | Tablet Salut Selaput | 5 mg/ 80 mg | Exforge 5/80 | DKI2197301017A1 Tanggal Terbit 09-09-2021 | SIEGFRIED BARBERA, S.L. - SPAIN | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 19 | Amlodipine Besilate/ Valsartan | Tablet Salut Selaput | 5 mg/ 160 mg | Exforge 5/160 | DKI2197301017B1 Tanggal Terbit 09-09-2021 | SIEGFRIED BARBERA, S.L. - SPAIN | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 20 | Amlodipine Besilate/ Valsartan | Tablet Salut Selaput | 10 mg/160 mg | Exforge 10/160 | DKI2197301017C1 Tanggal Terbit 09-09-2021 | SIEGFRIED BARBERA, S.L. - SPAIN | NOVARTIS 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 |
|---|---|---|---|---|---|---|---|---|
| 481 | Methotrexate | Tablet | 2,5 mg | Ferxate | DKI1816201410A1 Tanggal Terbit 06-05-2019 | KOREA UNITED PHARM, INC- KOREA | FERRON PAR PHARMACEUTICALS - INDONESIA | Obat Generik |
| 482 | Methylphenidate | Tablet | 10 mg | Methylphenidate HCl | GPL1733314310A1 Tanggal Terbit 22-06-2017 | MERSIFARMA TIRMAKU MERCUSANA - INDONESIA | MERSIFARMA TIRMAKU MERCUSANA - INDONESIA | Obat Generik |
| 483 | Metoprolol Tartrate | Tablet | 100 mg | Loprolol | DKL0609318710A1 Tanggal Terbit 27-01-2021 | IKAPHARMINDO PUTRAMAS - INDONESIA | IKAPHARMINDO PUTRAMAS - INDONESIA | Obat Generik |
| 484 | Mometasone furoate | Nasal spray suspension | 0.0005 | Modexa | DKI1849700156A1 Tanggal Terbit 24-04-2019 | GLENMARK PHARMACEUTICALS LTD - INDIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 485 | Montelukast Sodium | Oral granule | 4 mg | Rymont | DKL1833541522A1 Tanggal Terbit 31-07-2019 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 486 | Montelukast Sodium | Tablet Salut Selaput | 10,4 mg | Aspira | DKI2055600117A1 Tanggal Terbit 29-05-2020 | PHARMANIAGA MANUFACTURING BERHAD - MALAYSIA | ERRITA PHARMA - INDONESIA | Obat Generik |
| 487 | Montelukast Sodium | Tablet Salut Selaput | 11,18 mg | Montelukast Sodium | GKL1931543917A1 Tanggal Terbit 26-05-2020 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 488 | Moxifloxacin HCl | Kaplet Salut Selaput | 400 mg | Cyfloxan | DKL2113028809A1 Tanggal Terbit 12-05-2022 | KONIMEX - INDONESIA | KONIMEX - INDONESIA | Obat Generik |
| 489 | Moxifloxacin HCl | Kaplet Salut Selaput | 400 mg | Respira | DKL1333529809A1 Tanggal Terbit 09-05-2018 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 490 | Moxifloxacin HCl | Tablet salut selaput | 400 mg | Zigat | DKL1221642717A1 Tanggal Terbit 11-06-2019 | PHAROS INDONESIA - INDONESIA | PHAROS INDONESIA - INDONESIA | Obat Generik |
