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
181 Hyoscine Butylbromide Tablet Salut Gula 10 mg Buscopan DKL1821207716A1 Tanggal Terbit 05-09-2018 BOEHRINGER INGELHEIM INDONESIA - INDONESIA AVENTIS PHARMA - INDONESIA Obat Komparator
182 Hyoscine Butylbromide/ Paracetamol Tablet Salut Selaput 500/ 10 mg Buscopan Plus DKL1821207817A1 Tanggal Terbit 05-10-2018 BOEHRINGER INGELHEIM INDONESIA - INDONESIA AVENTIS PHARMA - INDONESIA Obat Komparator
183 Ibandronic acid Tablet Salut Selaput 150 mg Bonviva DKI2053100417A1 Tanggal Terbit 22-07-2021 PENN PHARMACEUTICAL SERVICES LTD - UK DIKEMAS OLEH WAYMADE PLC, BASILDON, UK ATAS DASAR LISENSI DARI ATNAHS PHARMA UK LIMITED, BASILDON, UK NUFARINDO - Indonesia Obat Komparator
184 Imatinib Tablet Salut Selaput 100 mg Glivec DKI2121001417A1 Tanggal Terbit 28-03-2021 NOVARTIS PHARMA GMBH - GERMANY NOVARTIS INDONESIA - INDONESIA Obat Komparator
185 Imatinib Tablet Salut Selaput 400 mg Glivec DKI2221001417B1 Tanggal Terbit 16-08-2022 NOVARTIS PHARMA PRODUKTIONS GMBH - Federal Republic of Germany NOVARTIS INDONESIA - INDONESIA Obat Komparator
186 Imidapril Tablet 10 mg Tanapress 10 DKL9725201210C1 Tanggal Terbit 01-03-2019 TANABE INDONESIA, INDONESIA DENGAN LISENSI MITSUBHI TANABE PHARMA CORP, JAPAN TANABE INDONESIA - INDONESIA Obat Komparator
187 Indapamide/ Perindopril Tablet Salut Selaput 5 mg/ 1,25 mg Bioprexum Plus DKI1631600517A1 Tanggal Terbit 19-09-2021 SERVIER INDUSTRIE LTD. - IRLANDIA DARYA VARIA LABORATORIA - INDONESIA Obat Komparator
188 Irbesartan Tablet Salut Selaput 300 mg Aprovel DKI1077402717C1 Tanggal Terbit 22-07-2021 SANOFI- WINTHROP - PERANCIS AVENTIS PHARMA - INDONESIA Obat Komparator
189 Irbesartan Tablet Salut Selaput 150 mg Aprovel DKI1077402717B1 Tanggal Terbit 22-07-2021 SANOFI- WINTHROP - PERANCIS AVENTIS PHARMA - INDONESIA Obat Komparator
190 Isosorbide Dinitrate Tablet 5 mg Cedocard 5 DKL7204520210A1 Tanggal terbit 23-10-2018 DARYA VARIA LABORATORIA - INDONESIA DARYA VARIA LABORATORIA - 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
151 Ciprofloxacin Tablet Salut Selaput 500 mg Ciflos 500 DKL9508003817B1 Tanggal Terbit 26-03-2019 GUARDIAN PHARMATAMA - INDONESIA GUARDIAN PHARMATAMA - INDONESIA Obat Generik
152 Ciprofloxacin Kaplet Salut Selaput 500 mg Cylowam 500 DKL9513008209B1 Tanggal Terbit 21-03-2019 KONIMEX - INDONESIA KONIMEX - INDONESIA Obat Generik
153 Ciprofloxacin Kaplet Salut Selaput 500 mg Siflox 500 DKL0433306609A1 Tanggal Terbit 15-10-2019 MERSIFARMA TIRMAKU MERCUSANA - INDONESIA MERSIFARMA TIRMAKU MERCUSANA - INDONESIA Obat Generik
154 Ciprofloxacin Kaplet Salut Selaput 500 mg Floksid DKL0033201609A1 Tanggal Terbit 18-12-2017 PROMEDRAHARDJO FARMASI INDUSTRI - INDONESIA PROMEDRAHARDJO FARMASI INDUSTRI - INDONESIA Obat Generik
155 Ciprofloxacin Kaplet Salut Selaput 500 mg Novaflox 500 DKL0634006009A1 Tanggal Terbit 24-09-2018 NOVAPHARIN - INDONESIA NOVAPHARIN - INDONESIA Obat Generik
156 Ciprofloxacin Kaplet Salut Selaput 500 mg Omeproksil DKL9916906809A1 Tanggal Terbit 10-09-2019 MUTIARA MUKTI FARMA - INDONESIA MUTIARA MUKTI FARMA - INDONESIA Obat Generik
157 Ciprofloxacin Kaplet Salut Selaput 500 mg Viflox DKL0226007409A1 Tanggal Terbit 09-02-2018 TROPICA MAS - INDONESIA TROPICA MAS - INDONESIA Obat Generik
158 Ciprofloxacin Kaplet Salut Selaput 500 mg Tequinol DKL9318811309A1 Tanggal Terbit 30-04-2019 OTTO PHARMACEUTICALS INDUSTRIES - INDONESIA OTTO PHARMACEUTICAL INDUSTRIES - INDONESIA Obat Generik
159 Ciprofloxacin Kaplet Salut Selaput 500 mg Volinol DKL9321006809A1 Tanggal Terbit 13-09-2019 PYRIDAM FARMA TBK - Indonesia PYRIDAM FARMA TBK - INDONESIA Obat Generik
160 Ciprofloxacin Kaplet Salut Selaput 500 mg Baquinor Forte DKL9222212809A1 Tanggal Terbit 31-10-2019 CAPRIFARMINDO LABORATORIES - INDONESIA SANBE FARMA - INDONESIA Obat Generik

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