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 |
|---|---|---|---|---|---|---|---|---|
| 141 | Ezetimibe | Tablet | 10 mg | Ezetrol | DKI0387101010A1 Tanggal Terbit 04-04-2020 | MSD INTERNATIONAL GMBH, PUERTO RICO | MERCK SHARP & DOHME PHARMA - INDONESIA | Obat Komparator |
| 142 | Favipiravir | Tablet Salut Selaput | 200 mg | Avigan | EUA2156200117A1 Tanggal Terbit 28-07-2021 | FUJIFILM TOYAMA CHEMICAL CO., LTD., TOYAMA FACTORY - JAPAN | BETA PHARMACON - INDONESIA | Obat Komparator |
| 143 | Febuxostat | Tablet | 80 mg | Feburic | DKI1729000610A1 Tanggal terbit 28 -05-2018 | PATHEON FRANCE, SA | MEPROFARM - INDONESIA | Obat Komparator |
| 144 | Fenofibrate | Tablet Salut Selaput | 160 mg | Lipanthyl Supra | DKI1481400717A1 Tanggal Terbit 31-12-2018 | RECIPHARM FONTAONE - PERANCIS | ABBOTT INDONESIA - INDONESIA | Obat Komparator |
| 145 | Fenofibrate | Kapsul | 300 mg | Lipanthyl 300 | DKL2000207601A1 Tanggal Terbit 20-09-2020 | COMBIPHAR - INDONESIA | ABBOTT INDONESIA - INDONESIA | Obat Komparator |
| 146 | Fenofibrate | Kapsul | 200 mg | Lipanthyl 200 M | DKL1804134101A1 Tanggal terbit 03-05-2018 | COMBIPHAR - INDONESIA | COMBIPHAR - INDONESIA | Obat Komparator |
| 147 | Fenofibrate | Tablet Salut Selaput | 145 mg | Lipanthyl Penta | DKI1181400517A1 Tanggal Terbit 17-12-2020 | RECIPHARM FONTAONE - PERANCIS | ABBOTT INDONESIA - INDONESIA | Obat Komparator |
| 148 | Fenoterol Hydrobromide | Aerosol | 100 mcg/dosis | Berotec | DKI0252501439A1 Tanggal Terbit 22-04-2021 | BOEHRINGER INGELHEIM WEST GERMANY | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 149 | Fexofenadine HCl | Tablet Salut Selaput | 180 mg | Telfast HD | DKL1221205217C1 Tanggal Terbit 17-01-2022 | AVENTIS PHARMA - INDONESIA | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 150 | Fexofenadine HCl | Tablet Salut Selaput | 120 mg | Telfast | DKL1121205217B1 Tanggal Terbit 26-05-2021 | AVENTIS PHARMA - INDONESIA | AVENTIS PHARMA - 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 |
|---|---|---|---|---|---|---|---|---|
| 191 | Clopidogrel | Tablet Salut Selaput | 75 mg | Clogin | DKL0917624217A1 Tanggal Terbit 08-08-2019 | INTERBAT - INDONESIA | INTERBAT - INDONESIA | Obat Generik |
| 192 | Clopidogrel | Tablet Salut Selaput | 75 mg | Clopid | DKL2108027217A1 Tanggal Terbit 17-11-2021 | GUARDIAN PHARMATAMA - INDONESIA | GUARDIAN PHARMATAMA - Indonesia | Obat Generik |
| 193 | Clozapine | Tablet | 25 mg | Clorilex | DKL0633309110A1 Tanggal terbit 21-11-2017 | MERSIFARMA TIRMAKU MERCUSANA - INDONESIA | MERSIFARMA TIRMAKU MERCUSANA - INDONESIA | Obat Generik |
| 194 | Clozapine | Tablet | 25 mg | Clozapine | GKL1605052410A1 Tanggal Terbit 21-09-2021 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 195 | Clozapine | Tablet | 25 mg | Sizoril | DKL0415617810A1 Tanggal terbit 20-12-2018 | MEPROFARM - INDONESIA | MEPROFARM - INDONESIA | Obat Generik |
| 196 | Clozapine | Tablet | 25 mg | Clozapine | GKL1609323410A1 Tanggal Terbit 04-03-2022 | IKAPHARMINDO PUTRAMAS - INDONESIA | IKAPHARMINDO PUTRAMAS - INDONESIA | Obat Generik |
| 197 | Clozapine | Tablet | 25 mg | Lozap | DKL1433531810A1 Tanggal Terbit 10-08-2021 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 198 | Clozapine | Tablet | 25 mg | Clozapine | GKL1715719410A1 Tanggal Terbit 24-04-2019 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 199 | Clozapine | Tablet | 25 mg | Clozapine | GKL1731808410B1 Tanggal Terbit 09-05-2019 | SUNTHI SEPURI - INDONESIA | SUNTHI SEPURI - INDONESIA | Obat Generik |
| 200 | Clozapine | Tablet | 25 mg | Clozapine 25 | GKL1233310410A1 Tanggal Terbit 27-12-2017 | MERSIFARMA TIRMAKU MERCUSANA - INDONESIA | MERSIFARMA TIRMAKU MERCUSANA - INDONESIA | Obat Generik |
