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
1 Acetylsalicylic Acid Tablet 300 mg Bayer Aspirin Filipina Bayer Bitterfeld GmbH OT Greppin – Germany] Bayer Phils., Inc -
2 Alendronate sodium Tablet 70 mg Fosamax USA - Merck And Co Inc -
3 Amitriptylline Tablet 10 mg; 25 mg;75 mg Tryptizol Italy - (Merck Sharp & Dohme, Lda. Atau Frosst Iberica, S.A.) Italy -
4 Amitriptylline Tablet 10 mg; 50 mg; 75 mg; 100 mg; 150 mg Amitriptylline Hydrochloride USA - Sandoz Inc -
5 Amoxicillin Kapsul 500 mg Amoxil Singapore Smithkline Beecham Limited (UK); Glaxo Wellcome Production (FR) Glaxosmithkline Pte Ltd -
6 Artemether (kombinasi dengan Lumefantrine) Tablet 20 mg/120 mg Riamet Malaysia - Novartis Corporation (Malaysia) Sdn. Bhd -
7 Artesunate - - Arsumax Arsuamoon - - Sanofi F Guilin Pharmaceuticals (China) -
8 Atenolol Tablet 100 mg Tenormin Malaysia Astrazeneca UK Limited Astrazeneca -
9 Carvedilol Tablet 25 mg Dilatrend Malaysia Delpharm Milano S.R.L, Italy DKSH Malaysia SDN BHD -
10 Cefdinir Kapsul 300 mg Cefdinir USA - Sandoz Inc -

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

No ZAT AKTIF BENTUK SEDIAAN KEKUATAN NAMA DAGANG NIE PRODUSEN PENDAFTAR STATUS
131 Cefixime Trihydrate Kaplet Salut Selaput 200 mg Ceptik 200 DKL0817623609A1 Tanggal Terbit 16-08-2022 INTERBAT - Indonesia INTERBAT - Indonesia Obat Generik
132 Cefixime Trihydrate Sirup Kering 100 mg/5 mL Cefarox DKL0435302738A1 Tanggal Terbit 22-06-2020 GRACIA PHARMINDO - INDONESIA GRACIA PHARMINDO - INDONESIA Obat Generik
133 Cefixime Trihydrate Sirup Kering 100 mg/5 mL Cefila DKL0813313938A1 Tanggal Terbit 28-08-2020 LAPI LABORATORIES - INDONESIA LAPI LABORATORIES - INDONESIA Obat Generik
134 Cefixime Trihydrate Sirup Kering 100 mg/5 mL Maxpro DKL9815613138A1 Tanggal Terbit 19-07-2020 MEPROFARM - INDONESIA MEPROFARM - INDONESIA Obat Generik
135 Cefixime Trihydrate Sirup Kering 100 mg/5 mL Anfix DKL0913705109A1 Tanggal Terbit 22-04-2021 DARYA VARIA LABORATORIA - INDONESIA MAHAKAM BETA FARMA - INDONESIA Obat Generik
136 Cefixime Trihydrate Sirup Kering 100 mg/5 mL Tocef DKL9602322838A1 Tanggal Terbit 16-02-2021 BERNOFARM - INDONESIA BERNOFARM - INDONESIA Obat Generik
137 Cefixime Trihydrate Sirup Kering 100 mg/5 mL Ceptik DKL9517611038A1 Tanggal Terbit 21-07-2022 INTERBAT - Indonesia INTERBAT - Indonesia Obat Generik
138 Cefixime Trihydrate Sirup Kering 100 mg/5 mL Starcef DKL9505014838A1 Tanggal Terbit 07-06-2022 DEXA MEDICA - INDONESIA DEXA MEDICA - INDONESIA Obat Generik
139 Cefixime Trihydrate Sirup Kering 100 mg/5 mL Profim DKL2233217538A1 Tanggal Terbit 04-03-2022 PROMEDRAHARDJO FARMASI INDUSTRI - Indonesia PROMEDRAHARDJO FARMASI INDUSTRI - INDONESIA Obat Generik
140 Cefixime Trihydrate Sirup Kering 100 mg/5 mL Cefixime Trihydrate GKL1340701738A1 Tanggal Terbit 06-12-2021 PHARMA LABORATORIES - Indonesia PHARMA LABORATORIES - Indonesia Obat Generik

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