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 |
|---|---|---|---|---|---|---|---|---|
| 1 | Abiraterone Acetate | Tablet | 250 mg | Zytiga | DKI1410900810A1 Tanggal Terbit 21-01-2019 | JANSSEN CILAG FARMACEUTICAL SpA - ITALY | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Komparator |
| 2 | Abiraterone Acetate | Tablet Salut Selaput | 500 mg | Zytiga | DKI1810901417A1 Tanggal Terbit 12-09-2019 | JANSSEN CILAG FARMACEUTICAL SpA - ITALY | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Komparator |
| 3 | Acetylsalicylic Acid | Tablet Salut Enterik | 100 mg | Cardio Aspirin | DKI9451600515A1 Tanggal Terbit 17-02-2022 | BAYER AG, LEVERKUSEN, FEDERAL REPUBLIC OF GERMANY UNTUK BAYER CONSUMER CARE AG, BASEL, SWITZERLAND | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 4 | Acetylsalicylic Acid/ Clopidogrel | Tablet Salut Selaput | 75 mg/ 100 mg | Coplavix | DKI1977404315A1 Tanggal Terbit 04-04-2019 | SANOFI- WINTHROP - PERANCIS | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 5 | Aciclovir | Tablet | 200 mg | Zovirax | DKI1691601310A1 Tanggal Terbit 11-10-2021 | GLAXO WELLCOME S.A., ARANDA DE DIERO, SPAIN | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 6 | Adefovir Dipivoxil | Tablet | 10 mg | Hepsera | DKI1033700110A1 Tanggal Terbit 13-09-2019 | GLAXO SMITHKLINE CO. LTD - (TIANJIN) CHINA | SMITH KLINE BEECHAM PHARMACEUTICAL IND. - INDONESIA | Obat Komparator |
| 7 | Agomelatine | Tablet Salut Selaput | 25 mg | Valdoxan | DKI1668601517A1 Tanggal Terbit 16-02-2022 | LES LABORATORIES SERVIER - FRANCE | DARYA VARIA LABORATORIA - INDONESIA | Obat Komparator |
| 8 | Aliskiren Fumarate | Tablet Salut Selaput | 150 mg | Rasilez | DKI0767506817A1 Tanggal Terbit 18-01-2018 | NOVARTIS PHARMA STEIN A.G., STEIN - SWISS | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 9 | Aliskiren Fumarate | Tablet Salut Selaput | 300 mg | Rasilez | DKI0767506817B1 Tanggal Terbit 18-01-2018 | NOVARTIS PHARMA STEIN A.G., STEIN - SWISS | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 10 | Allopurinol | Tablet | 100 mg | Zyloric | DKL9932004210A1 Tanggal Terbit 21-01-2019 | GLAXO WELLCOME INDONESIA - INDONESIA | GLAXO WELLCOME 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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|---|
| 171 | Ciprofloxacin HCl | Kaplet salut selaput | 500 mg | Etaflox | DKL1106506509A1 Tanggal Terbit 22-04-2022 | ERRITA PHARMA - Indonesia | ERRITA PHARMA - Indonesia | Obat Generik |
| 172 | Ciprofloxacin HCl | Kaplet salut selaput | 500 mg | Licoprox | DKL0310804309A1 Tanggal Terbit 08-09-2022 | BERLICO MULIA FARMA - Indonesia | BERLICO MULIA FARMA - Indonesia | Obat Generik |
| 173 | Clopidogrel | Tablet Salut Selaput | 75 mg | Clopidogrel bisulfate | GKL1008516509A1 Tanggal Terbit 07-11-2017 | KALBE FARMA - INDONESIA | HEXPHARM JAYA LABORATORIES - INDONESIA | Obat Generik |
| 174 | Clopidogrel | Tablet Salut Selaput | 75 mg | Clopidogrel bisulfate | GKL1413709517A1 Tanggal Terbit 22-06-2020 | MAHAKAM BETA FARMA - INDONESIA | MAHAKAM BETA FARMA - INDONESIA | Obat Generik |
| 175 | Clopidogrel | Tablet Salut Selaput | 75 mg | Therodel | DKL1422253210A1 Tanggal Terbit 25-12-2019 | SANBE FARMA - INDONESIA | SANBE FARMA - INDONESIA | Obat Generik |
| 176 | Clopidogrel | Tablet Salut Selaput | 75 mg | Medigrel | DKL1333212817A1 Tanggal Terbit 09-02-2018 | PROMEDRAHARDJO FARMASI INDUSTRI - INDONESIA | PROMEDRAHARDJO FARMASI INDUSTRI - INDONESIA | Obat Generik |
| 177 | Clopidogrel | Tablet Salut Selaput | 75 mg | Clopidogrel | GKL1320939517A1 Tanggal Terbit 31-08-2018 | INDOFARMA - INDONESIA | INDOFARMA - INDONESIA | Obat Generik |
| 178 | Clopidogrel | Tablet Salut Selaput | 75 mg | Clopidogrel | GKL1212525617A1 Tanggal Terbit 17-12-2018 | KIMIA FARMA - INDONESIA | KIMIA FARMA - INDONESIA | Obat Generik |
| 179 | Clopidogrel | Tablet Salut Selaput | 75 mg | Copidrel | DKL0919614917A1 Tanggal Terbit 22-04-2021 | PERTIWI AGUNG - INDONESIA | PERTIWI AGUNG - INDONESIA | Obat Generik |
| 180 | Clopidogrel | Tablet Salut Selaput | 75 mg | CPG | DKL0811638017A2 Tanggal Terbit 14-04-2020 | KALBE FARMA - INDONESIA | KALBE FARMA - INDONESIA | Obat Generik |
