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 |
|---|---|---|---|---|---|---|---|---|
| 71 | Metoprolol | Tablet | (Metoprolol tartrate) 50 mg; 100 mg | Betaloc | Malaysia, Australia | Aztrazeneca Pharmaceutical Co. Ltd, China (MY) | Astrazeneca | - |
| 72 | Metoprolol | Tablet pelepasan lambat | (Metoprolol succinate) 95 mg | Betazok | Philippines | Astrazeneca AB, Sweden | Aztrazeneca Pharmaceuticals (Phils.) Inc | - |
| 73 | Metronidazole | Kapsul | 250 mg; 375 mg; 500 mg | Flagyl | USA | - | Pfizer Inc | - |
| 74 | Metronidazole | Tablet | 400 mg | Flagyl | Australia | - | Sanovi Aventis | - |
| 75 | Minocycline | Tablet lepas lambat | EQ 115 mg base | Solodyn | USA | - | BAUSCH HEALTH US LLC | - |
| 76 | Minocycline | Kapsul | 50 mg; 100 mg | Minocin | USA | - | BAUSCH HEALTH US LLC | - |
| 77 | Mirtazapine | Tablet | 30 mg; 15 mg | Remeron Sol Tab | Malaysia | - | Merck Sharp & Dohme Pharma - Malaysia | - |
| 78 | Molnupiravir | Kapsul | 200 mg | Lagevrio | Malaysia; UK | Patheon Inc, Canada (MY); Merck Sharp & Dohme BV, Netherland (UK) | Merck Sharp & Dohme (Malaysia) Sdn Bhd (MY); Merck Sharp & Dohme (UK) Limited (UK) | - |
| 79 | Nateglinide | Tablet salut selaput | 120 mg | Starlix | Germany | Germany | Novartis Europharm Limited | - |
| 80 | Nevirapine | Tablet | 200 mg | Viramune | USA | - | Boehringer Ingelheim | - |
LIST OF GENERIC DRUGS THAT HAVE MEET THE BIOECIVALENCE CRITERIA IN 2022
| No | ZAT AKTIF | BENTUK SEDIAAN | KEKUATAN | NAMA DAGANG | NIE | PRODUSEN | PENDAFTAR | STATUS |
|---|---|---|---|---|---|---|---|---|
| 31 | Amiodarone Hydrochloride | Tablet | 200 mg | Tiaryt | DKL9531510310A1 Tanggal Terbit 23-05-2019 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 32 | Amiodarone Hydrochloride | Tablet | 200 mg | Kendaron | DKL0004515410A1 Tanggal Terbit 09-09-2020 | DARYA VARIA LABORATORIA TBK PLANT CITEUREUP - INDONESIA | DARYA VARIA LABORATORIA - INDONESIA | Obat Generik |
| 33 | Amiodarone Hydrochloride | Tablet | 200 mg | Amiodarone Hydrochloride | GKL1833542510A1 Tanggal Terbit 11-01-2019 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 34 | Amitriptyline hydrochloride | Tablet Salut Selaput | 25 mg | Amitriptyline hydrochloride | GKL9832706817A1 Tanggal Terbit 14-02-2022 | YARINDO FARMATAMA - Indonesia | YARINDO FARMATAMA - INDONESIA | Obat Generik |
| 35 | Amlodipine | Tablet | 10 mg | Amlodipine besylate | GKL2144402510A1 Tanggal Terbit 24-07-2022 | KIMIA FARMA Tbk. - Indonesia | KIMIA FARMA Tbk. - Indonesia | Obat Generik |
| 36 | Amlodipine | Kaplet | 10 mg | Cardisan 10 | DKL0822244610B1 Tanggal Terbit 15-06-2022 | SANBE FARMA - INDONESIA | SANBE FARMA (UNIT 1) - Indonesia | Obat Generik |
| 37 | Anastrozole | Tablet Salut Selaput | 1 mg | Sterazol | DKI2035401217A1 Tanggal Terbit 01-05-2020 | INTAS PHARMACEUTICAL LTD. - INDIA | NUFARINDO - INDONESIA | Obat Generik |
| 38 | Anastrozole | Tablet Salut Selaput | 1 mg | Forinaz | DKI2249100317A1 Tanggal Terbit 21-09-2022 | CADILA HEALTHCARE LIMITED - India | MEGA LIFESCIENCES INDONESIA - Indonesia | Obat Generik |
| 39 | Anastrozole | Tablet Salut Selaput | 1 mg | ATZ | DKI1943400317A1 Tanggal Terbit 12-10-2019 | SYNTHON HISPANIA, S.L. - Spain | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 40 | Anastrozole | Tablet Salut Selaput | 1 mg | Anzonat | DKI2049500517A1 Tanggal Terbit 14-04-2020 | NATCO PHARMA LIMITED - INDIA | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Generik |
