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 |
|---|---|---|---|---|---|---|---|---|
| 91 | Deferasirox | Tablet Dispersible | 500 mg | Exjade | DKI0667505281A1 Tanggal Terbit 25-11-2020 | NOVARTIS PHARMA AG - SWITZERLAND | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 92 | Deferasirox | Tablet Salut Selaput | 360 | Exjade | DKI1867509517C1 Tanggal Terbit 02-09-2019 | NOVARTIS PHARMA AG - SWITZERLAND | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 93 | Deferasirox | Tablet Dispersible | 250 mg | Exjade | DKI0667505281B1 Tanggal Terbit 25-11-2020 | NOVARTIS PHARMA AG - SWITZERLAND | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 94 | Deferasirox | Tablet Dispersible | 125 mg | Exjade | DKI0667505281C1 Tanggal Terbit 25-11-2020 | NOVARTIS PHARMA AG - SWITZERLAND | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 95 | Deferasirox | Tablet Salut Selaput | 90 | Exjade | DKI1867509517A1 Tanggal Terbit 02-09-2019 | NOVARTIS PHARMA AG - SWITZERLAND | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 96 | Deferasirox | Tablet Salut Selaput | 180 | Exjade | DKI1867509517B1 Tanggal Terbit 02-09-2019 | NOVARTIS PHARMA STEIN A.G., STEIN - SWISS | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 97 | Deferiprone | Tablet Salut Selaput | 500 mg | Ferriprox | DKI1119200117A1 Tanggal Terbit 09-05-2022 | APOTEX INC., CANADA | SYDNA FARMA - INDONESIA | Obat Komparator |
| 98 | Desloratadine/ Pseudoephedrine sulfate | Tablet Lepas Lambat | 120 mg/2,5 mg | Aerius D-12 | DKI0987101714A1 Tanggal terbit 05-08-2021 | PATHEON INC., WHITBY, CANADA, DIKEMAS DAN DIRILIS OLEH SCHERING-PLOUGH LABO NV, HEIST-OP-DEN-BERG, 2220, BELGIUM | ORGANON PHARMA INDONESIA TBK - Indonesia | Obat Komparator |
| 99 | Dexketoprofen | Tablet | 25 mg | Ketesse | DKL0405036517A2 Tanggal Terbit 29-03-2018 | DEXA MEDICA - INDONESIA DENGAN LISENSI DARI MENARINI INTERNATIONAL OPERATION, GERMANY | DEXA MEDICA - INDONESIA | Obat Komparator |
| 100 | Diacerein | Kapsul | 50 mg | Artrodar | DKI0411100101A1 Tanggal Terbit 27-01-2021 | TRB CHEMEDICA INTERNATIONAL SA, SWISS TRB PHARMA S.A. - Argentina Pemberi Lisensi TRB CHEMEDICA INTERNATIONAL SA - Switzerland | COMBIPHAR - 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 |
|---|---|---|---|---|---|---|---|---|
| 51 | Ketoconazole | Tablet | 200 mg | Ketoconazole | USA | - | TARO PHARMACEUTICAL INDUSTRIES LTD | - |
| 52 | Ketoprofen | Tablet pelepasan lambat | 150 mg | Bi-Profenid | Poland | - | Sanofi-Aventis | - |
| 53 | Ketoprofen | Kapsul pelepasan lambat | 200 mg | Profenid LP 200 | France; Austria | - | Sanofi-Aventis, France; Sanofi-Aventis, Austria | - |
| 54 | Ketoprofen | Kapsul | 50 mg | Profenid | France; Austria | - | Sanofi-Aventis, France; Sanofi-Aventis, Austria | - |
| 55 | Ketoprofen | Tablet salut selaput | 100 mg | Profenid | France; Austria | - | Sanofi-Aventis, France; Sanofi-Aventis, Austria | - |
| 56 | Lansoprazole | Kapsul lepas tunda | 30 mg | Takepron atau Prevacid | Australia, USA, UK | - | Takeda Teva atau Takeda | - |
| 57 | Lenalidomide | Kapsul | 25 mg | Revlimid | Malaysia, USA | - | Celgene International Switzerlan (MY); Celgene Corp (US) | - |
| 58 | Levodopa (kombinasi Carbidopa) | Tablet | 200 mg/50 mg | Sinemet CR | Singapore | - | ORGANON SINGAPORE PTE. LTD. | - |
| 59 | Levodopa (kombinasi Carbidopa) | Tablet | 200 mg/50 mg | Sinemet CR | Australia | - | ORGANON PHARMA PTY LTD | - |
| 60 | Lisinopril | Tablet | Lisinopril 5 mg; 10 mg; 20 mg | Zestril | Malaysia, Philippines, Australia | Aztrazeneca Pharmaceutical Co. Ltd, China (MY, PH) | AstraZeneca Pharmaceutical | - |
LIST OF GENERIC DRUGS THAT HAVE MEET THE BIOECIVALENCE CRITERIA IN 2022
| No | ZAT AKTIF | BENTUK SEDIAAN | KEKUATAN | NAMA DAGANG | NIE | PRODUSEN | PENDAFTAR | STATUS |
|---|---|---|---|---|---|---|---|---|
| 91 | Bisoprolol Fumarate | Tablet Salut Selaput | 5 mg | Bisoprolol | GKL0608513317A1 Tanggal Terbit 22-04-2022 | HEXPHARM JAYA LABORATORIES - INDONESIA | HEXPHARM JAYA LABORATORIES - INDONESIA | Obat Generik |
| 92 | Bisoprolol Fumarate | Tablet Salut Selaput | 5 mg | Biscor | DKL0605041617A1 Tanggal Terbit 28-01-2019 | FERRON PAR PHARMACEUTICALS - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 93 | Bisoprolol Fumarate | Tablet Salut Selaput | 5 mg | Bisoprolol Fumarate | GKL0633516517A1 Tanggal Terbit 21-03-2019 | ETERCON PHARMA - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 94 | Bisoprolol Fumarate | Tablet Salut Selaput | 5 mg | Opiprol 5 | DKL1718829417B1 Tanggal Terbit 23-03-2018 | OTTO PHARMACEUTICALS INDUSTRIES - INDONESIA | OTTO PHARMACEUTICAL INDUSTRIES - INDONESIA | Obat Generik |
| 95 | Candesartan Cilexetil | Tablet | 16 mg | Canderin | DKL1105045910B1 Tanggal Terbit 16-07-2021 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 96 | Candesartan Cilexetil | Tablet | 16 mg | Gionix | DKL1521645010B1 Tanggal Terbit 12-04-2022 | PHAROS INDONESIA - INDONESIA | PHAROS INDONESIA - INDONESIA | Obat Generik |
| 97 | Candesartan Cilexetil | Tablet | 16 mg | Candesartan cilexetil | GKL2208520810A1 Tanggal Terbit 19-04-2022 | HEXPHARM JAYA LABORATORIES - Indonesia | HEXPHARM JAYA LABORATORIES - Indonesia | Obat Generik |
| 98 | Candesartan Cilexetil | Tablet | 16 mg | Blocand 16 | DKL1821024310B1 Tanggal Terbit 14-05-2019 | PYRIDAM FARMA TBK - Indonesia | PYRIDAM FARMA TBK - INDONESIA | Obat Generik |
| 99 | Candesartan Cilexetil | Tablet | 16 mg | Candesartan | GKL1502349710B1 Tanggal Terbit 22-03-2021 | BERNOFARM - INDONESIA | BERNOFARM - INDONESIA | Obat Generik |
| 100 | Candesartan Cilexetil | Tablet | 16 mg | Candefar 16 | DKL1731539310B1 Tanggal Terbit 29-03-2018 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
