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 |
|---|---|---|---|---|---|---|---|---|
| 21 | Desogestrel | Tablet salut selaput | 0,075 mg | Cerazette | Philippines | NV Organon Netherland | Organon / Merck Sharp & Dohme | - |
| 22 | Dexamethasone | Tablet | 1mg; 2mg; 4mg; 6mg | Dexamethasone | USA | - | Hikma Pharmaceuticals USA Inc | - |
| 23 | Diazepam | Tablet | 10 mg | Valium | Philippines, USA | - | Roche (Phil), Hoffmann La Roche (US) | - |
| 24 | Digoxin | Tablet | 250 mcg | Lanoxin | USA, Malaysia, Philippines | ` | CONCORDIA PHARMACEUTICALS INC; Aspen Medical Products (MY); Aspen (PH) | - |
| 25 | Dihydroartemisinin (kombinasi Piperaquine) | Tablet Salut Selaput | 20 mg/160 mg; 40/320 mg | Eurartesim | Germany, Netherland | - | Alfasigma SpA | - |
| 26 | Disopyramide | Kapsul | 150 mg | Norpace | USA | - | PFIZER INC | - |
| 27 | Disopyramide | Kapsul lepas lambat | 150 mg | Norpace CR | USA | - | PFIZER INC | - |
| 28 | Doxycycline | Suspensi | 25 mg/5ml | Vibramycin | USA | - | PFIZER LABORATORIES DIV PFIZER INC | - |
| 29 | Doxycycline (as Hydrochloride) | Kapsul | 100 mg | Vibramycin | Australia, Philippines | - | Pfizer | - |
| 30 | Drospirenone | Tablet | 4 mg | SLYND | USA | - | EXELTIS USA 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 |
|---|---|---|---|---|---|---|---|---|
| 651 | Valsartan | Tablet salut selaput | 160 mg | Tyoval 160 | DKL1333530617C1 Tanggal Terbit 08-11-2018 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 652 | Valsartan | Kaplet Salut Selaput | 160 mg | Vartan | DKL1921026409A1 Tanggal Terbit 27-08-2019 | PYRIDAM FARMA TBK - Indonesia | PYRIDAM FARMA TBK - INDONESIA | Obat Generik |
| 653 | Valsartan | Tablet Salut Selaput | 160 mg | Valsartan | GKL1808518917B1 Tanggal Terbit 31-12-2018 | KALBE FARMA - INDONESIA | HEXPHARM JAYA LABORATORIES - INDONESIA | Obat Generik |
| 654 | Valsartan | Tablet Salut Selaput | 160 mg | Valsartan | GKL2044401817A1 Tanggal Terbit 10-09-2020 | KIMIA FARMA - INDONESIA | KIMIA FARMA - INDONESIA | Obat Generik |
| 655 | Valsartan | Kaplet Salut Selaput | 160 mg | Tensor 160 | DKL2217630609A1 Tanggal Terbit 14-06-2022 | INTERBAT - Indonesia | INTERBAT - Indonesia | Obat Generik |
| 656 | Valsartan/ Amlodipin | Kaplet Salut Selaput | 160 mg/ 10 mg | Vardipin 10/ 160 | DKI1953000309B1 Tanggal Terbit 22-09-2019 | DASAN PHARMACEUTICAL CO., LTD. - KOREA | OTTO PHARMACEUTICAL INDUSTRIES - INDONESIA | Obat Generik |
| 657 | Velpatasvir/ Sofosbuvir | Kaplet Salut Selaput | 100 mg/ 400 mg | Myhep all | DKI2040401009A1 Tanggal Terbit 12-11-2020 | MYLAN LABORATORIES LIMITED - INDIA | INDOFARMA - INDONESIA | Obat Generik |
| 658 | Warfarin Sodium | Tablet | 2 mg | Simarc | DKL9531511110A1 Tanggal terbit 09-09-2021 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 659 | Warfarin Sodium Clathrate | Tablet | 5 mg | Notisil 5 | DKL1333529710A1 Tanggal Terbit 13-05-2020 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 660 | Zolpidem Tartrate | Kaplet Salut Selaput | 10 mg | Zudem | DPL1408021609A1 Tanggal Terbit 01-07-2020 | GUARDIAN PHARMATAMA, CITEUREUP - INDONESIA | GUARDIAN PHARMATAMA - INDONESIA | Obat Generik |
