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
11 Allopurinol Tablet 100 mg Zyloric DKL9932004210A1 Tanggal Terbit 21-01-2019 GLAXO WELLCOME INDONESIA - INDONESIA GLAXO WELLCOME INDONESIA - INDONESIA Obat Komparator
12 Alprazolam Kaplet 0,25 mg Xanax DPI1054200604A1 Tanggal Terbit 30-10-2020 PFIZER ITALIA S.R.L - ITALY PFIZER INDONESIA - INDONESIA Obat Komparator
13 Alprazolam Kaplet 0,5 mg Xanax DPI1054200604B1 Tanggal Terbit 30-10-2020 PFIZER ITALIA S.R.L - ITALY PFIZER INDONESIA - INDONESIA Obat Komparator
14 Alprazolam Kaplet 1 mg Xanax DPI1054200604C1 Tanggal Terbit 30-10-2020 PFIZER ITALIA S.R.L - ITALY PFIZER INDONESIA - INDONESIA Obat Komparator
15 Amiodarone Tablet 200 mg Cordarone DKL1421205810A1 Tanggal Terbit 21-10-2021 AVENTIS PHARMA - INDONESIA AVENTIS PHARMA - INDONESIA Obat Komparator
16 Amlodipine Besilate Tablet 5 mg Norvask DKL9219803410A1 Tanggal Terbit 08-10-2018 PFIZER INDONESIA - INDONESIA PFIZER INDONESIA - INDONESIA Obat Komparator
17 Amlodipine Besilate Tablet 10 mg Norvask DKL9619803410B1 Tanggal Terbit 08-10-2018 PFIZER INDONESIA - INDONESIA PFIZER INDONESIA - INDONESIA Obat Komparator
18 Amlodipine Besilate/ Valsartan Tablet Salut Selaput 5 mg/ 80 mg Exforge 5/80 DKI2197301017A1 Tanggal Terbit 09-09-2021 SIEGFRIED BARBERA, S.L. - SPAIN NOVARTIS INDONESIA - INDONESIA Obat Komparator
19 Amlodipine Besilate/ Valsartan Tablet Salut Selaput 5 mg/ 160 mg Exforge 5/160 DKI2197301017B1 Tanggal Terbit 09-09-2021 SIEGFRIED BARBERA, S.L. - SPAIN NOVARTIS INDONESIA - INDONESIA Obat Komparator
20 Amlodipine Besilate/ Valsartan Tablet Salut Selaput 10 mg/160 mg Exforge 10/160 DKI2197301017C1 Tanggal Terbit 09-09-2021 SIEGFRIED BARBERA, S.L. - SPAIN NOVARTIS INDONESIA - 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
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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