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 |
|---|---|---|---|---|---|---|---|---|
| 41 | Azithromycin Dihyrdate | Sirup Kering | 209.75 mg | Zithromax | DKI9684800538A1 Tanggal Terbit 03-07-2019 | HAUPT PHARMA LATINA S.R.L. - ITALY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 42 | Azithromycin Dihyrdate | Kaplet Salut Selaput | 250 mg | Zithromax | DKL9319803309A1 Tanggal Terbit 24-05-2020 | PFIZER INDONESIA - INDONESIA | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 43 | Azithromycin Dihyrdate | Tablet Salut Selaput | 500 mg | Zithromax | DKL9519804017A1 Tanggal Terbit 24-05-2020 | PFIZER INDONESIA - INDONESIA | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 44 | Beclometasone Dipropionate + Formoterol Fumarate Dihydrate | PRESSURISED METERED DOSE INHALER (PMDI) - HYDROFLUOROALKANE (HFA) | 0.006 mg/ 0.100 mg | Innovair | DKI1460600568A1 Tanggal Terbit 31-03-2020 | CHIESI FARMACEUTICI S.P.A - ITALY | TUNGGAL IDAMAN ABDI - INDONESIA | Obat Komparator |
| 45 | Beclometasone Dipropionate/ Formoterol Fumarat Dihydrate | Serbuk inhaler | 0,100 mg /0,006 mg | Innovair Nexthaler | DKI2060600667A1 Tanggal Terbit 08-07-2020 | CHIESI FARMACEUTICI S.P.A - ITALY | TUNGGAL IDAMAN ABDI - INDONESIA | Obat Komparator |
| 46 | Benserazide HCl/ Levodopa | Tablet Dispersible | 28.5 mg/ 100 mg | Madopar | DKI1857507581A1 Tanggal Terbit 26-04-2019 | DELPHARM MILANO S.R.L - ITALY | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 47 | Beraprost sodium | Tablet | 20 mcg | Dorner | DKI1020200210A1 Tanggal Terbit 06-03-2020 | TORAY INDUSTRIES, INC. MISHIMA PLANT, MISHIMA, JAPAN | PT. COMBIPHAR - INODNESIA | Obat Komparator |
| 48 | Betahistine Mesilate | Tablet | 6 mg | Merislon | DKL7206101010A1 Tanggal Terbit 15-03-2022 | EISAI INDONESIA - INDONESIA LISENSI DARI EISAI - JAPAN | EISAI INDONESIA - INDONESIA | Obat Komparator |
| 49 | Bicalutamide | Tablet salut selaput | 150 mg | Casodex | DKI1235300117B1 Tanggal Terbit 05-04-2022 | ASTRAZENECA INDONESIA - INDONESIA | ASTRAZENECA UK LIMITED | Obat Komparator |
| 50 | Bisoprolol Fumarate | Tablet Salut Selaput | 10 mg | Concor | DKL9115803817B1 Tanggal Terbit 18-06-2020 | MERCK INDONESIA TBK - INDONESIA LISENSI OLEH MERCK HEALTHCARE KGAA - FEDERAL REPUBLIC OF GERMANY | MERCK TBK - 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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
