BE Test Comparator Products

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
31 Efavirenz Tablet 600 mg Stocrin/ Sustiva Malaysia, Australia, USA - Merck Sharp & Dohme (Australia) Bristol Myers Squibb (USA) -
32 Efavirenz Kapsul 50 mg; 200 mg Sustiva USA - Bristol Myers Squibb -
33 Efavirenz (kombinasi dengan Emtricitabine dan Tenofovir) Tablet 600 mg/200mg/ 300 mg Atripla Australia, USA - Gilead Sciences -
34 Efavirenz (kombinasi dengan Lamivudine dan Tenofovir) Tablet 600 mg/300 mg/300 mg Symfi USA - Mylan Laboratories Ltd -
35 Efavirenz (kombinasi dengan Lamivudine dan Tenofovir) Tablet 400 mg/300 mg/300 mg Symfi Lo USA - Mylan Pharmaceuticals Inc -
36 Emtricitabine (kombinasi Tenofovir) Tablet 200/300 mg Truvada Australia, USA - Gilead Sciences -
37 Enalapril Tablet 2,5 mg; 5 mg; 10 mg Vasotec USA - BAUSCH HEALTH US LLC -
38 Entecavir Tablet Salut Selaput 0,5 mg; 1 mg Baraclude Singapore, USA, Philippines AstraZeneca Pharmaceuticals UNITED STATES, USA Bristol Myers Squibb -
39 Ethambutol Tablet 400 mg Myambutol Germany, Switzerland, USA, UK - Riemser Arzneimittel or Teopharma; Labatec Pharma, Switzerland; STI Pharma LLC, USA; Genus Pharmaceuticals Ltd, UK -
40 Felodipine Tablet pelepasan lambat 1,5 mg; 5 mg; 10 mg Plendil Malaysia, Philippines Aztrazeneca Pharmaceutical Co. Ltd, China Astrazeneca -

LIST OF GENERIC DRUGS THAT HAVE MEET THE BIOECIVALENCE CRITERIA IN 2022

No ZAT AKTIF BENTUK SEDIAAN KEKUATAN NAMA DAGANG NIE PRODUSEN PENDAFTAR STATUS
651 Valsartan Tablet salut selaput 160 mg Tyoval 160 DKL1333530617C1 Tanggal Terbit 08-11-2018 NOVELL PHARMACEUTICAL LAB - INDONESIA NOVELL PHARMACEUTICAL LAB - INDONESIA Obat Generik
652 Valsartan Kaplet Salut Selaput 160 mg Vartan DKL1921026409A1 Tanggal Terbit 27-08-2019 PYRIDAM FARMA TBK - Indonesia PYRIDAM FARMA TBK - INDONESIA Obat Generik
653 Valsartan Tablet Salut Selaput 160 mg Valsartan GKL1808518917B1 Tanggal Terbit 31-12-2018 KALBE FARMA - INDONESIA HEXPHARM JAYA LABORATORIES - INDONESIA Obat Generik
654 Valsartan Tablet Salut Selaput 160 mg Valsartan GKL2044401817A1 Tanggal Terbit 10-09-2020 KIMIA FARMA - INDONESIA KIMIA FARMA - INDONESIA Obat Generik
655 Valsartan Kaplet Salut Selaput 160 mg Tensor 160 DKL2217630609A1 Tanggal Terbit 14-06-2022 INTERBAT - Indonesia INTERBAT - Indonesia Obat Generik
656 Valsartan/ Amlodipin Kaplet Salut Selaput 160 mg/ 10 mg Vardipin 10/ 160 DKI1953000309B1 Tanggal Terbit 22-09-2019 DASAN PHARMACEUTICAL CO., LTD. - KOREA OTTO PHARMACEUTICAL INDUSTRIES - INDONESIA Obat Generik
657 Velpatasvir/ Sofosbuvir Kaplet Salut Selaput 100 mg/ 400 mg Myhep all DKI2040401009A1 Tanggal Terbit 12-11-2020 MYLAN LABORATORIES LIMITED - INDIA INDOFARMA - INDONESIA Obat Generik
658 Warfarin Sodium Tablet 2 mg Simarc DKL9531511110A1 Tanggal terbit 09-09-2021 PRATAPA NIRMALA - INDONESIA PRATAPA NIRMALA - INDONESIA Obat Generik
659 Warfarin Sodium Clathrate Tablet 5 mg Notisil 5 DKL1333529710A1 Tanggal Terbit 13-05-2020 NOVELL PHARMACEUTICAL LAB - INDONESIA NOVELL PHARMACEUTICAL LAB - INDONESIA Obat Generik
660 Zolpidem Tartrate Kaplet Salut Selaput 10 mg Zudem DPL1408021609A1 Tanggal Terbit 01-07-2020 GUARDIAN PHARMATAMA, CITEUREUP - INDONESIA GUARDIAN PHARMATAMA - INDONESIA Obat Generik

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