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 |
|---|---|---|---|---|---|---|---|---|
| 71 | Cholecalciferol | Kapsul Lunak | 5000 IU | Tride | DKL2002507102A1 Tanggal terbit 26 September 2020 | DIPA PHARMALAB INTERSAINS - INDONESIA | DIPA PHARMALAB INTERSAINS - INDONESIA | Obat Komparator |
| 72 | Cholecalciferol | Tablet kunyah | 5000 IU | HI-D5000 | DKL1909504363B1 Tanggal terbit 02 Maret 2020 | IMEDCO DJAJA - INDONESIA | IMEDCO DJAJA - INDONESIA | Obat Komparator |
| 73 | Ciclosporin | Kapsul Lunak | 100 mg | Sandimmun Neoral | DKI1921001202C1 Tanggal Terbit 07-06-2020 | CATALENT GERMANY EBERBACH GMBH - FEDERAL REPUBLIC OF GERMANY | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 74 | Ciclosporin | Kapsul Lunak | 50 mg | Sandimmun Neoral | DKI1921001202B1 Tanggal Terbit 07-06-2020 | CATALENT GERMANY EBERBACH GMBH - FEDERAL REPUBLIC OF GERMANY | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 75 | Ciclosporin | Kapsul Lunak | 25 mg | Sandimmun Neoral | DKI1921001202A1 Tanggal Terbit 07-06-2020 | CATALENT GERMANY EBERBACH GMBH - FEDERAL REPUBLIC OF GERMANY | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 76 | Cilostazol | Tablet | 50 mg | Pletaal | DKL0318706110A1 Tanggal Terbit 26-05-2021 | OTSUKA INDONESIA - INDONESIA pemberi lisensi OTSUKA PHARMACEUTICAL CO., LTD TOKYO JAPAN - Japan | OTSUKA INDONESIA - INDONESIA | Obat Komparator |
| 77 | Cilostazol | Tablet | 100 mg | Pletaal | DKL0318706110B1 Tanggal Terbit 26-05-2021 | OTSUKA INDONESIA - INDONESIA pemberi lisensi OTSUKA PHARMACEUTICAL CO., LTD TOKYO JAPAN - Japan | OTSUKA INDONESIA - INDONESIA | Obat Komparator |
| 78 | Ciprofibrate | Kaplet | 100 mg | Modalim | DKL1321205604A1 Tanggal Terbit 01-08-2018 | AVENTIS PHARMA - INDONESIA | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 79 | Ciprofloxacin HCl | Tablet Salut Selaput | 500 mg | Ciproxin | DKL1902009617A1 Tanggal Terbit 12-04-2019 | BAYER INDONESIA - INDONESIA | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 80 | Clarithromycin | Tablet Lepas Lambat | 500 mg | Abbotic XL | DKI0075500414A1 Tanggal Terbit 30-01-2018 | ABBOTT INDONESIA - INDONESIA | ABBOTT 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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|---|
| 611 | Sildenafil Citrate | Kaplet Salut Selaput | 100 mg | Sildenafil Citrate | GKL1832719909A1 Tanggal Terbit 23-05-2019 | YARINDO FARMATAMA - INDONESIA | YARINDO FARMATAMA - INDONESIA | Obat Generik |
| 612 | Sildenafil Citrate | Oral Dissolving Film | 70241 | Ericfil 50 | DKL2233554519A1 Tanggal Terbit 12-04-2022 | ETERCON PHARMA - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 613 | Sildenafil Citrate | Kaplet Salut Selaput | 140,48 mg | Zifagra | DKL2009226209A1 Tanggal Terbit 16-02-2021 | IFARS PHARMACEUTICAL LABORATORIES - INDONESIA | IFARS PHARMACEUTICAL LABORATORIES - INDONESIA | Obat Generik |
| 614 | Sildenafil Citrate | Tablet salut selaput | 140,48 mg | Camastil | DKL2143501917A1 Tanggal Terbit 20-06-2021 | AMAROX PHARMA GLOBAL - INDONESIA | AMAROX PHARMA GLOBAL - INDONESIA | Obat Generik |
| 615 | Sildenafil Citrate | Tablet Salut Selaput | 140,5 mg | Amigra 100 | DKL2138601017A1 Tanggal Terbit 06-12-2021 | SATRIA BUMIKERTA - AMIDA FARMA - Indonesia | SATRIA BUMIKERTA - AMIDA FARMA - Indonesia | Obat Generik |
| 616 | Simvastatin, Ezetimibe | Kaplet | 20 mg, 10 mg | Ezetatin | DKL1907923604A1 Tanggal Terbit 17-11-2019 | HARSEN - INDONESIA | HARSEN - INDONESIA | Obat Generik |
| 617 | Sofosbuvir | Tablet salut selaput | 400 mg | Hepcinat | DKI1849500117A1 Tanggal Terbit 08-03-2019 | NATCO PHARMA LIMITED - INDIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 618 | Sofosbuvir | Tablet salut selaput | 400 mg | Sobuvir | DKI1746800117A1 Tanggal Terbit 09-05-2018 | STRIDES SHASUN LIMITED-INDIA | BERNOFARM - INDONESIA | Obat Generik |
| 619 | Sofosbuvir | Tablet salut selaput | 400 mg | Sofohep | DKI2025601017A1 Tanggal Terbit 26-09-2020 | AUROBINDO PHARMA LIMITED - INDIA | INDOFARMA - INDONESIA | Obat Generik |
| 620 | Sofosbuvir/ Ledispavir Premix | Tablet salut selaput | 400 mg/ 180 mg | Lisof | DKI2018603117A1 Tanggal Terbit 25-02-2020 | HETERO LABS LIMITED - INDIA | AMAROX PHARMA GLOBAL - INDONESIA | Obat Generik |
