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 |
|---|---|---|---|---|---|---|---|---|
| 81 | Nevirapine | Tablet pelepasan lambat | 400 mg | Viramune | USA, Australia | - | Boehringer Ingelheim | - |
| 82 | Nifedipine | Kapsul | 10 mg | Procardia | USA | - | Pfizer | - |
| 83 | Nifedipine | Tablet | 10 mg; 20 mg | Adalat | Australia | - | Bayer | - |
| 84 | Nitroglycerin | Tablet sublingual | 0,3; 0,4 dan 0,6 mg | Nitrostat | USA | - | UPJOHN US 1 LLC | - |
| 85 | Omeprazole | Kapsul lepas tunda | 20 mg | Losec | Philippines; New Zealand, Sweden | Astra Zeneca AB, Sweden | - | - |
| 86 | Ondansetron | Tablet salut selaput | 8 mg; 4 mg | Zofran | Austria; EU | - | Novartis Pharma GmbH, Austria | - |
| 87 | Piroxicam | Kapsul | 20 mg | Feldene | USA, France | Fareva Amboise (FR) | Pfizer Laboratories | - |
| 88 | Pravastatin | TABLET | 80 mg | Pravastatin Sodium | USA | - | Teva Pharmaceuticals USA | - |
| 89 | Primaquine | Tablet | 15 mg | Primaquine Phosphate | USA | - | Sanofi Aventis US LLC | - |
| 90 | Pyrazinamide | Tablet | 500 mg | Pyrafat | Germany | - | Riemser Pharma GMBH | - |
LIST OF GENERIC DRUGS THAT HAVE MEET THE BIOECIVALENCE CRITERIA IN 2022
| No | ZAT AKTIF | BENTUK SEDIAAN | KEKUATAN | NAMA DAGANG | NIE | PRODUSEN | PENDAFTAR | STATUS |
|---|---|---|---|---|---|---|---|---|
| 11 | Aciclovir | Tablet | 400 mg | Matrovir | DKL0513022610A1 Tanggal Terbit 17-11-2021 | KONIMEX - INDONESIA | KONIMEX - INDONESIA | Obat Generik |
| 12 | Aciclovir | Tablet | 400 mg | Samclovir | DKL0823410310A1 Tanggal Terbit 29-07-2021 | SAMPHARINDO PERDANA - INDONESIA | SAMPHARINDO PERDANA - INDONESIA | Obat Generik |
| 13 | Aciclovir | Tablet | 400 mg | Clinovir | DKL9321614310B1 Tanggal Terbit 30-03-2020 | PHAROS INDONESIA - INDONESIA | PHAROS INDONESIA - INDONESIA | Obat Generik |
| 14 | Aciclovir | Tablet | 400 mg | Acifar 400 | DKL0509207204B1 Tanggal Terbit 22-04-2019 | IFARS PHARMACEUTICAL LABORATORIES - INDONESIA | IFARS PHARMACEUTICAL LABORATORIES - INDONESIA | Obat Generik |
| 15 | Aciclovir | Tablet | 400 mg | Aciclovir | GKL0433510110B1 Tanggal Terbit 29-08-2019 | ETERCON PHARMA - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 16 | Aciclovir | Tablet | 400 mg | Aciclovir | GKL1132703710B1 Tanggal Terbit 23-10-2018 | YARINDO FARMATAMA - INDONESIA | YARINDO FARMATAMA - INDONESIA | Obat Generik |
| 17 | Aciclovir | Tablet | 400 mg | Aciclovir | GKL9812415010B1 Tanggal Terbit 15-09-2020 | KIMIA FARMA - INDONESIA | KIMIA FARMA - INDONESIA | Obat Generik |
| 18 | Aciclovir | Tablet | 400 mg | Aciclovir | GKL0108504810B1 Tanggal Terbit 17-11-2021 | HEXPHARM JAYA LABORATORIES - INDONESIA | HEXPHARM JAYA LABORATORIES - INDONESIA | Obat Generik |
| 19 | Aciclovir | Tablet | 200 mg | Aciclovir | GKL9812415010A1 Tanggal Terbit 27-12-2021 | KIMIA FARMA - INDONESIA | KIMIA FARMA - INDONESIA | Obat Generik |
| 20 | Aciclovir | Tablet | 200 mg | Aciclovir | GKL9832703710A1 Tanggal Terbit 02-01-2020 | YARINDO FARMATAMA - INDONESIA | YARINDO FARMATAMA - INDONESIA | Obat Generik |
