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
21 Amlodipine Besilate/ Atorvastatin Calcium Trihydrate Tablet Salut Selaput 10/ 10 mg Caduet DKI1258501317C1 Tanggal Terbit 22-07-2021 PFIZER- GERMANY PFIZER INDONESIA - INDONESIA Obat Komparator
22 Amlodipine Besilate/ Atorvastatin Calcium Trihydrate Tablet Salut Selaput 20/ 5 mg Caduet DKI1258501317B1 Tanggal Terbit 22-07-2021 PFIZER- GERMANY PFIZER INDONESIA - INDONESIA Obat Komparator
23 Amlodipine Besilate/ Atorvastatin Calcium Trihydrate Tablet Salut Selaput 20/ 10 mg Caduet DKI1258501317D1 Tanggal Terbit 22-07-2021 PFIZER- GERMANY PFIZER INDONESIA - INDONESIA Obat Komparator
24 Amlodipine Besilate/ Atorvastatin Calcium Trihydrate Tablet Salut Selaput 10/ 5 mg Caduet DKI1258501317A1 Tanggal Terbit 22-07-2021 PFIZER- GERMANY PFIZER INDONESIA - INDONESIA Obat Komparator
25 Amlodipine Besilate/ Bisoprolol Fumarate Tablet 5 mg/ 5 mg Concor AM DKI1952900110A1 Tanggal Terbit 28-03-2021 EGIS PHARMACEUTICALS PLC. MERCK TBK - INDONESIA Obat Komparator
26 Amlodipine Besilate/ Bisoprolol Fumarate Tablet 5 mg/ 10 mg Concor AM DKI1952900110B1 Tanggal Terbit 28-03-2021 EGIS PHARMACEUTICALS PLC. MERCK TBK - INDONESIA Obat Komparator
27 Amlodipine Besilate/ Bisoprolol Fumarate Tablet 10 mg/ 5 mg Concor AM DKI1952900110C1 Tanggal Terbit 28-03-2021 EGIS PHARMACEUTICALS PLC. MERCK TBK - INDONESIA Obat Komparator
28 Amoxicillin Sirup Kering 125 mg/ 5 mL Amoxsan DKL0732401438A1 Tanggal terbit 08 Februari 2022 CAPRIFARMINDO LABORATORIES - INDONESIA SANBE FARMA (UNIT 2) - INDONESIA Obat Komparator
29 Anastrozole Tablet Salut Selaput 1 mg Arimidex DKI1335300417A1 Tanggal Terbit 10-09-2022 ASTRAZENECA PHARMACEUTICALS LP - USA Dikemas dan Dirilis Oleh ASTRAZENECA PHARMACEUTICAL COMPANY LTD., WUXI, CHINA Untuk ASTRAZENECA UK LIMITED, MACCLESFIELD, UNITED KINGDOM ASTRAZENECA - INDONESIA Obat Komparator
30 Apixaban Tablet Salut Selaput 2,5 mg Eliquis DKI2190702117A1 Tanggal Terbit 17-11-2021 PFIZER IRELAND PHARMACEUTICALS - Ireland PFIZER 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
661 Zolpidem Tartrate Tablet salut selaput 10 mg Zolmia DPL0331523217A1 Tanggal Terbit 09-09-2021 PRATAPA NIRMALA - INDONESIA PRATAPA NIRMALA - INDONESIA Obat Generik
662 Zolpidem Tartrate Tablet salut selaput 10 mg Zolta DPL1233526617A1 Tanggal Terbit 23-06-2022 NOVELL PHARMACEUTICAL LAB - INDONESIA NOVELL PHARMACEUTICAL LAB - INDONESIA Obat Generik

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