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 |
|---|---|---|---|---|---|---|---|---|
| 351 | Thiamazole | Tablet Salut Selaput | 10 mg | Thyrozol | DKI0063401417B2 Tanggal Terbit 19-04-2022 | MERCK HEALTHCARE KGAA - FEDERAL REPUBLIC OF GERMANY | MERCK TBK - INDONESIA | Obat Komparator |
| 352 | Ticagrelor | Tablet Salut Selaput | 90 mg | Brilinta | DKI1635301117A1 Tanggal Terbit 23-03-2021 | ASTRAZENECA PHARMACEUTICAL COMPANY LTD. | ASTRAZENECA - INDONESIA | Obat Komparator |
| 353 | Ticagrelor | Tablet Salut Selaput | 60 mg | Brilinta | DKI1751303217A1 Tanggal terbit 21-01-2018 | ASTRAZENECA PHARMACEUTICALS - SWEDEN | ASTRAZENECA - INDONESIA | Obat Komparator |
| 354 | Tizanidine | Tablet | 2,28 mg | Sirdalud | DKL9330406410A1 Tanggal terbit 28 April 2021 | NOVARTIS INDONESIA - INDONESIA | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 355 | Topiramate | Tablet | 100 mg | Topamax | DKI1060000710C1 Tanggal Terbit 31-03-2020 | CILAG CHEMIE - SWITZERLAND | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Komparator |
| 356 | Topiramate | Tablet | 50 mg | Topamax | DKI1060000710B1 Tanggal Terbit 31-03-2020 | CILAG CHEMIE - SWITZERLAND | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Komparator |
| 357 | Topiramate | Tablet | 25 mg | Topamax | DKI1060000710A1 Tanggal Terbit 31-03-2020 | CILAG CHEMIE - SWITZERLAND | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Komparator |
| 358 | Topiramate | Kapsul | 25 mg | Topamax | DKI1210900501B1 Tanggal Terbit 09-04-2022 | JANSSEN ORTHO, LLC. - Puerto Rico | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Komparator |
| 359 | Topiramate | Kapsul | 15 mg | Topamax | DKI1210900501A1 Tanggal Terbit 09-04-2022 | JANSSEN ORTHO, LLC. - Puerto Rico | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Komparator |
| 360 | Trimetazidine | Tablet Salut Selaput Lepas Lambat | 35 mg | Trizedon MR | DKL1604524514A1 Tanggal terbit 17 Desember 2020 | DARYA VARIA LABORATORIA, INDONESIA LISENSI DARI LES LABORATORIES SERVIER - FRANCE | DARYA VARIA LABORATORIA - 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 |
|---|---|---|---|---|---|---|---|---|
| 111 | Tizanidine | Kapsul | 6 mg | Zanaflex | USA | - | COVIS PHARMA GMBH | - |
| 112 | Trimetazidine | Tablet pelepasan lambat | 35 mg | Vastarel MR | Malaysia, Singapore | Les Labs Servier Industrie, France | - | - |
| 113 | Warfarin | Tablet | 5 mg | Coumadin; Warfarin sodium 10 mg (US) | Australia, USA | - | Viatris Pty Ltd (Australia); Pliva (US) | - |
| 114 | Zidovudine | Kapsul | 100 mg | Retrovir | Australia, USA | - | ViiV Healthcare | - |
LIST OF GENERIC DRUGS THAT HAVE MEET THE BIOECIVALENCE CRITERIA IN 2022
| No | ZAT AKTIF | BENTUK SEDIAAN | KEKUATAN | NAMA DAGANG | NIE | PRODUSEN | PENDAFTAR | STATUS |
|---|---|---|---|---|---|---|---|---|
| 31 | Amiodarone Hydrochloride | Tablet | 200 mg | Tiaryt | DKL9531510310A1 Tanggal Terbit 23-05-2019 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 32 | Amiodarone Hydrochloride | Tablet | 200 mg | Kendaron | DKL0004515410A1 Tanggal Terbit 09-09-2020 | DARYA VARIA LABORATORIA TBK PLANT CITEUREUP - INDONESIA | DARYA VARIA LABORATORIA - INDONESIA | Obat Generik |
| 33 | Amiodarone Hydrochloride | Tablet | 200 mg | Amiodarone Hydrochloride | GKL1833542510A1 Tanggal Terbit 11-01-2019 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 34 | Amitriptyline hydrochloride | Tablet Salut Selaput | 25 mg | Amitriptyline hydrochloride | GKL9832706817A1 Tanggal Terbit 14-02-2022 | YARINDO FARMATAMA - Indonesia | YARINDO FARMATAMA - INDONESIA | Obat Generik |
| 35 | Amlodipine | Tablet | 10 mg | Amlodipine besylate | GKL2144402510A1 Tanggal Terbit 24-07-2022 | KIMIA FARMA Tbk. - Indonesia | KIMIA FARMA Tbk. - Indonesia | Obat Generik |
| 36 | Amlodipine | Kaplet | 10 mg | Cardisan 10 | DKL0822244610B1 Tanggal Terbit 15-06-2022 | SANBE FARMA - INDONESIA | SANBE FARMA (UNIT 1) - Indonesia | Obat Generik |
| 37 | Anastrozole | Tablet Salut Selaput | 1 mg | Sterazol | DKI2035401217A1 Tanggal Terbit 01-05-2020 | INTAS PHARMACEUTICAL LTD. - INDIA | NUFARINDO - INDONESIA | Obat Generik |
| 38 | Anastrozole | Tablet Salut Selaput | 1 mg | Forinaz | DKI2249100317A1 Tanggal Terbit 21-09-2022 | CADILA HEALTHCARE LIMITED - India | MEGA LIFESCIENCES INDONESIA - Indonesia | Obat Generik |
| 39 | Anastrozole | Tablet Salut Selaput | 1 mg | ATZ | DKI1943400317A1 Tanggal Terbit 12-10-2019 | SYNTHON HISPANIA, S.L. - Spain | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 40 | Anastrozole | Tablet Salut Selaput | 1 mg | Anzonat | DKI2049500517A1 Tanggal Terbit 14-04-2020 | NATCO PHARMA LIMITED - INDIA | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Generik |
