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 |
|---|---|---|---|---|---|---|---|---|
| 81 | Clobazam | Tablet pelepasan lambat | 10 mg | Frisium | DPL0121203810A1 Tanggal Terbit 01-08-2018 | AVENTIS PHARMA INDONESIA | AVENTIS PHARMA -NDONESIA | Obat Komparator |
| 82 | Clodronate Disodium | Kapsul | 400 mg | Bonefos | DKI0775601101A1 Tanggal Terbit 04-01-2018 | BAYER SCHERING PHARMA OY - FINLAND | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 83 | Clodronate Disodium | Tablet Salut Selaput | 800 mg | Bonefos | DKI0775601217A1 Tanggal Terbit 04-01-2018 | BAYER SCHERING PHARMA OY - FINLAND | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 84 | Clopidogrel | Tablet Salut Selaput | 97,875 mg | Plavix | DKL1321205717A1 Tanggal Terbit 04-08-2019 | AVENTIS PHARMA - INDONESIA | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 85 | Clopidogrel | Tablet Salut Selaput | 391,5 mg | Plavix | DKI1377403617B1 Tanggal Terbit 18-03-2022 | SANOFI- WINTHROP - PERANCIS | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 86 | Cyproterone Acetate/ Ethinyl Estradiol | Tablet Salut Gula | 2 mg/ 0,035 mg | Diane 35 | DKI0868204416A1 Tanggal Terbit 30-08-2022 | BAYER WEIMAR GMBH UND CO. KG - Federal Republic of Germany | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 87 | Dabigatran Etexilate Mesilate | Kapsul | 110 mg | Pradaxa | DKI0952502201B1 Tanggal Terbit 23-10-2018 | BOEHRINGER INGELHEIM WEST GERMANY | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 88 | Dabigatran Etexilate Mesilate | Kapsul | 75 mg | Pradaxa | DKI0952502201A1 Tanggal Terbit 23-10-2018 | BOEHRINGER INGELHEIM WEST GERMANY | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 89 | Dabigatran Etexilate Mesilate | Kapsul | 172,95 mg | Pradaxa | DKI1152502201C1 Tanggal Terbit 04-10-2020 | BOEHRINGER INGELHEIM WEST GERMANY | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 90 | Dapaglifozin | Tablet Salut Selaput | 10 mg | Forxiga | DKI1735301317B1 Tanggal terbit 22-03-2018 | ASTRAZENECA INDONESIA - INDONESIA | ASTRAZENECA UK LIMITED | 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 |
|---|---|---|---|---|---|---|---|---|
| 241 | Divalproex sodium | Kapsul salut enterik | 250 mg | Epilepsan | DKL2222263107A1 Tanggal Terbit 19-04-2022 | SANBE FARMA (UNIT 1) - Indonesia | SANBE FARMA - INDONESIA | Obat Generik |
| 242 | Divalproex sodium | Kaplet pelepasan Lambat | 538,159 mg | Forlepsi ER | DKL2032721106A1 Tanggal Terbit 27-09-2020 | YARINDO FARMATAMA - INDONESIA | YARINDO FARMATAMA - INDONESIA | Obat Generik |
| 243 | Divalproex sodium | Tablet pelepasan Lambat | 538,2 mg | Divalproex Sodium | GKL1905061714B1 Tanggal Terbit 19-07-2020 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 244 | Dolutegravir | Tablet salut selaput | 50 mg | Auroteg 50 | DKI2225601117A1 Tanggal Terbit 31-03-2022 | AUROBINDO PHARMA LIMITED - India | INDOFARMA - INDONESIA | Obat Generik |
| 245 | Dolutegravir | Tablet salut selaput | 50 mg | Dinisivir 50 | DKI2154801417A1 Tanggal Terbit 07-10-2021 | MACLEODS PHARMACEUTICALS LIMITED - India | SAMPHARINDO RETROVIRAL INDONESIA - Indonesia | Obat Generik |
| 246 | Dolutegravir | Tablet salut selaput | 50 mg | Mytelga | DKI2140401317A1 Tanggal Terbit 17-11-2021 | MYLAN LABORATORIES LIMITED - India | KIMIA FARMA Tbk. - Indonesia | Obat Generik |
| 247 | Dolutegravir/Lamivudine/Tenofovir disoproxil fumarate | Tablet salut selaput | 50 mg/300mg/300 mg | Teldy | DKI2118604117A1 Tanggal Terbit 11-11-2021 | HETERO LABS LIMITED - India | AMAROX PHARMA GLOBAL - INDONESIA | Obat Generik |
| 248 | Dolutegravir/Lamivudine/Tenofovir disoproxil fumarate | Tablet salut selaput | 50 mg/300mg/300 mg | Viropil | DKI2263900117A1 Tanggal Terbit 23-06-2022 | EMCURE PHARMACEUTICALS LTD - India | IMEDCO DJAJA - INDONESIA | Obat Generik |
| 249 | Domperidone | Tablet cepat larut | 10 mg | Dominal | DKL0405512682A1 Tanggal Terbit 11-06-2021 | ACTAVIS - INDONESIA | ACTAVIS - INDONESIA | Obat Generik |
| 250 | Donepezil HCl | Tablet Salut Selaput | 5 mg | Donacept | DKL1333530517A1 Tanggal Terbit 18-06-2020 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
