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
81 Bicalutamide Tablet Salut Selaput 50 mg Promod 50 DKI1935400617A1 Tanggal Terbit 12-10-2019 INTAS PHARMACEUTICAL LTD. - INDIA MERSIFARMA TIRMAKU MERCUSANA - INDONESIA Obat Generik
82 Bicalutamide Tablet Salut Selaput 150 mg Biluron 150 DKI1943400517B1 Tanggal Terbit 06-12-2019 SYNTHON HISPANIA, S.L. - Spain PRATAPA NIRMALA - INDONESIA Obat Generik
83 Bicalutamide Tablet Salut Selaput 50 mg Bicastra DKI1618600817A1 Tanggal Terbit 23-03-2021 HETERO LABS LIMITED - INDIA FERRON PAR PHARMACEUTICALS - INDONESIA Obat Generik
84 Bicalutamide Tablet Salut Selaput 150 mg Calutami 150 DKI1884400517B1 Tanggal Terbit 21-01-2019 CHONG KUN DANG PHARMACEUTICAL - REPUBLIC OF KOREA OTTO PHARMACEUTICAL INDUSTRIES - INDONESIA Obat Generik
85 Bicalutamide Tablet Salut Selaput 50 mg Biluron 50 DKI1943400517A1 Tanggal Terbit 06-12-2019 SYNTHON HISPANIA, S.L. - Spain PRATAPA NIRMALA - INDONESIA Obat Generik
86 Bisoprolol fumarate Tablet salut selaput 5 mg Tencard DKL2144403617B1 Tanggal Terbit 01-11-2021 KIMIA FARMA Tbk. - Indonesia KIMIA FARMA Tbk. - Indonesia Obat Generik
87 Bisoprolol Fumarate Tablet Salut Selaput 5 mg Selbix DKL1702354617A1 Tanggal Terbit 17-10-2018 BERNOFARM - INDONESIA BERNOFARM - INDONESIA Obat Generik
88 Bisoprolol Fumarate Tablet Salut Selaput 5 mg Konblobet DKL2013028017A1 Tanggal Terbit 18-08-2021 KONIMEX - INDONESIA KONIMEX - INDONESIA Obat Generik
89 Bisoprolol Fumarate Tablet Salut Selaput 5 mg Miniten DKL13025025117A1 Tanggal Terbit 14-03-2018 DIPA PHARMALAB INTERSAINS - INDONESIA DIPA PHARMALAB INTERSAINS - INDONESIA Obat Generik
90 Bisoprolol Fumarate Tablet Salut Selaput 5 mg Bisoprolol Fumarate GKL0633516517A1 Tanggal Terbit 21-03-2019 ETERCON PHARMA - INDONESIA NOVELL PHARMACEUTICAL LAB - INDONESIA Obat Generik

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