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
91 Deferasirox Tablet Dispersible 500 mg Exjade DKI0667505281A1 Tanggal Terbit 25-11-2020 NOVARTIS PHARMA AG - SWITZERLAND NOVARTIS INDONESIA - INDONESIA Obat Komparator
92 Deferasirox Tablet Salut Selaput 360 Exjade DKI1867509517C1 Tanggal Terbit 02-09-2019 NOVARTIS PHARMA AG - SWITZERLAND NOVARTIS INDONESIA - INDONESIA Obat Komparator
93 Deferasirox Tablet Dispersible 250 mg Exjade DKI0667505281B1 Tanggal Terbit 25-11-2020 NOVARTIS PHARMA AG - SWITZERLAND NOVARTIS INDONESIA - INDONESIA Obat Komparator
94 Deferasirox Tablet Dispersible 125 mg Exjade DKI0667505281C1 Tanggal Terbit 25-11-2020 NOVARTIS PHARMA AG - SWITZERLAND NOVARTIS INDONESIA - INDONESIA Obat Komparator
95 Deferasirox Tablet Salut Selaput 90 Exjade DKI1867509517A1 Tanggal Terbit 02-09-2019 NOVARTIS PHARMA AG - SWITZERLAND NOVARTIS INDONESIA - INDONESIA Obat Komparator
96 Deferasirox Tablet Salut Selaput 180 Exjade DKI1867509517B1 Tanggal Terbit 02-09-2019 NOVARTIS PHARMA STEIN A.G., STEIN - SWISS NOVARTIS INDONESIA - INDONESIA Obat Komparator
97 Deferiprone Tablet Salut Selaput 500 mg Ferriprox DKI1119200117A1 Tanggal Terbit 09-05-2022 APOTEX INC., CANADA SYDNA FARMA - INDONESIA Obat Komparator
98 Desloratadine/ Pseudoephedrine sulfate Tablet Lepas Lambat 120 mg/2,5 mg Aerius D-12 DKI0987101714A1 Tanggal terbit 05-08-2021 PATHEON INC., WHITBY, CANADA, DIKEMAS DAN DIRILIS OLEH SCHERING-PLOUGH LABO NV, HEIST-OP-DEN-BERG, 2220, BELGIUM ORGANON PHARMA INDONESIA TBK - Indonesia Obat Komparator
99 Dexketoprofen Tablet 25 mg Ketesse DKL0405036517A2 Tanggal Terbit 29-03-2018 DEXA MEDICA - INDONESIA DENGAN LISENSI DARI MENARINI INTERNATIONAL OPERATION, GERMANY DEXA MEDICA - INDONESIA Obat Komparator
100 Diacerein Kapsul 50 mg Artrodar DKI0411100101A1 Tanggal Terbit 27-01-2021 TRB CHEMEDICA INTERNATIONAL SA, SWISS TRB PHARMA S.A. - Argentina Pemberi Lisensi TRB CHEMEDICA INTERNATIONAL SA - Switzerland COMBIPHAR - 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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