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 |
|---|---|---|---|---|---|---|---|---|
| 101 | Ritonavir | Tablet | 100 mg | Norvir | Malaysia, Australia | - | Roche (Malaysia) Sdn Bhd | - |
| 102 | Roflumilast | tablet | 500 mcg | Daxas (MY) atau Daliresp (US) | Malaysia, USA | Takeda GMBH Germany (MY) | AstraZeneca Pharmaceutical | - |
| 103 | Simvastatin | Tablet | 10 mg; 20 mg dan 40 mg | Zocor | Malaysia, Philippines, Australia | Merck Sharp & Dohme Ltd, UK (MY,PH) | Merck Sharp & Dohme (MY&PHIL); Organon Pharma (AU) | - |
| 104 | Sofosbuvir | Tablet salut selaput | 400 mg | Sovaldi | Malaysia, Australia, USA | - | Gilead Sciences (US) | - |
| 105 | Spironolactone | tablet | 100 mg | Aldactone | Philippines, United Kingdom | Piramal Healthcare UK Ltd (PH) | Pfizer Inc | - |
| 106 | Tamoxifen | Tablet | 20 mg | Nolvadex | Singapore | Astrazeneca UK Ltd | Astrazeneca Singapore PTE Ltd | - |
| 107 | Tamsulosin | Kapsul | 0,4 mg | Flomax | USA | - | Sanofi Aventis US | - |
| 108 | Tenofovir disoproxil Fumarate | Tablet Salut Selaput | 300 mg | Viread | Australia, USA | - | Gilead Sciences | - |
| 109 | Theophylline | Tablet | 100 mg | Theovent | Poland | - | GlaxoSmithKline Pharmaceuticals S.A | - |
| 110 | Theophylline | Tablet prolonged release | 250 mg | Euphyllin CR | Poland | - | Takeda | - |
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 |
