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 |
|---|---|---|---|---|---|---|---|---|
| 321 | Sildenafil Citrate | Tablet Salut Selaput | 50 mg | Viagra | DKI1690401417A1 Tanggal terbit 28-12-2018 | FAREVA AMBOISE, AMBOISE - PERANCIS | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 322 | Sildenafil Citrate | Tablet Salut Selaput | 100 mg | Viagra | DKI1690401417B1 Tanggal terbit 17-10-2018 | FAREVA AMBOISE, AMBOISE - PERANCIS | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 323 | Sitagliptin | Tablet Salut Selaput | 100 mg | Januvia | DKI1485200817C1 Tanggal Terbit 13-05-2019 | MERCK SHARP & DOHME LIMITED, CRAMLINGTON - UK | MERCK SHARP & DOHME PHARMA - INDONESIA | Obat Komparator |
| 324 | Sofosbuvir/ Ledispavir Premix | Tablet salut selaput | 400/ 90 mg | Harvoni | DKI1744200217A1 Tanggal Terbit 04-01-2018 | GILEAD SCIENCES IRELAND - IRELAND | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Komparator |
| 325 | Sofosbuvir/Velpatasvir | Tablet salut selaput | 400/ 100 mg | Epclusa | DKI1844200317A1 Tanggal Terbit 05-04-2019 | GILEAD SCIENCES IRELAND - IRELAND | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Komparator |
| 326 | Sulpiride | Kapsul | 50 mg | Dogmatil | DKL7624229901A1 Tanggal Terbit 21-10-2022 | SOHO INDUSTRI PHARMASI - INDONESIA atas lisensi SANOFI - France | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Komparator |
| 327 | Sulpiride | Tablet | 200 mg | Dogmatil Forte | DKL7824230010A1 Tanggal Terbit 21-10-2022 | SOHO INDUSTRI PHARMASI - INDONESIA atas lisensi SANOFI - France | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Komparator |
| 328 | Sunitinib Malate | Kapsul | 50 mg; 25 mg; 12,5 mg | Sutent | DKI0754200701A1 Tanggal terbit 04 Januari 2018 | PFIZER ITALIA S.R.L - ITALY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 329 | Tacrolimus | Kapsul | 0,5 mg | Prograf | DKI1108000201A1 Tanggal Terbit 01-05-2021 | ASTELLAS IRELAND, CO LTD - IRELAND | COMBIPHAR - INDONESIA | Obat Komparator |
| 330 | Tacrolimus | Kapsul | 1 mg | Prograf | DKI1108000201B1 Tanggal Terbit 01-05-2021 | ASTELLAS IRELAND, CO LTD - IRELAND | 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 |
|---|---|---|---|---|---|---|---|---|
| 91 | Pyrazinamide | Tablet | 500 mg | Pyrazinamide | USA | - | Akorn Inc | - |
| 92 | Pyrazinamide | Tablet | 500 mg | Zinamide | UK | - | Genus Pharmaceuticals Ltd | - |
| 93 | Repaglinide | Tablet | 0,5; 1 mg; 2 mg | NovoNorm | Malaysia, Philippines | Boehringer Ingelheim Pharma KG, Germany | Novo Nordisk | - |
| 94 | Ribavirin | Kapsul | 200 mg | Rebetol | USA | - | Merck Sharp & Dohme | - |
| 95 | Ribavirin | Tablet | 200 mg | Copegus | Malaysia | - | Pharma Corpia | - |
| 96 | Rifampicin | Kapsul | 300 mg; 150 mg | Rimactane | UK | - | Sandoz (Austria) | - |
| 97 | Rifampicin | Kapsul | 300 mg; 150 mg | Rifadin | Netherland | Sanofi SpA, Italy | Genzyme Europe BV | - |
| 98 | Rifampicin | Kapsul | 300 mg; 150 mg | Rifampicin | Netherland | - | Sandoz | - |
| 99 | Risperidone | Tablet | 1 mg | Risperdal | Australia, Malaysia, Philippines | Janssen Cilag SPA, Italy (MY, PH) | JANSSEN CILAG PTY LTD; Johnson & Johnson (MY, PH) | - |
| 100 | Risperidone | Tablet | 2 mg | Risperdal | Australia, Malaysia, Philippines | Janssen Cilag SPA, Italy (MY, PH) | JANSSEN CILAG PTY LTD; Johnson & Johnson (MY, PH)) | - |
LIST OF GENERIC DRUGS THAT HAVE MEET THE BIOECIVALENCE CRITERIA IN 2022
| No | ZAT AKTIF | BENTUK SEDIAAN | KEKUATAN | NAMA DAGANG | NIE | PRODUSEN | PENDAFTAR | STATUS |
|---|---|---|---|---|---|---|---|---|
| 101 | Candesartan Cilexetil/Amlodipin besylate | Tablet | 8 mg/5 mg | Canderin Duo | DKL2105065610A1 Tanggal Terbit 10-12-2021 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 102 | Capecitabine | Tablet Salut Selaput | 500 mg | Taceral | DKI1735400217A1 Tanggal Terbit 12-05-2022 | INTAS PHARMACEUTICAL LTD. - INDIA | KALBE FARMA - INDONESIA | Obat Generik |
| 103 | Capecitabine | Tablet Salut Selaput | 500 mg | Fercab | DKI2261100217A1 Tanggal Terbit 02-04-2022 | SHILPA MEDICARE LIMITED - India | FONKO INTERNATIONAL PHARMACEUTICALS - Indonesia | Obat Generik |
| 104 | Captopril | Tablet | 25 mg | Farmoten | DKL9131501810A1 Tanggal Terbit 21-11-2018 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 105 | Captopril | Tablet | 25 mg | Etapril | DKL1106506210A1 Tanggal Terbit 15-02-2021 | ERRITA PHARMA - INDONESIA | ERRITA PHARMA - INDONESIA | Obat Generik |
| 106 | Captopril | Tablet | 25 mg | Prix | DKL9728909710B1 Tanggal Terbit 06-03-2021 | RAMA EMERALD MULTI SUKSES - INDONESIA | RAMA EMERALD MULTI SUKSES - INDONESIA | Obat Generik |
| 107 | Captopril | Tablet | 25 mg | Vapril 25 | DKL9719919510B1 Tanggal Terbit 22-04-2020 | PHAPROS - INDONESIA | PHAPROS - INDONESIA | Obat Generik |
| 108 | Captopril | Tablet | 25 mg | Tensicap | DKL9222208310B1 Tanggal Terbit 17-12-2019 | SANBE FARMA - INDONESIA | SANBE FARMA - INDONESIA | Obat Generik |
| 109 | Captopril | Tablet | 25 mg | Captopril | GKL2244404410A1 Tanggal Terbit 07-04-2022 | KIMIA FARMA Tbk. - Indonesia | KIMIA FARMA Tbk. - Indonesia | Obat Generik |
| 110 | Carbamazepine | Kaplet Salut Selaput | 200 mg | Bamgetol 200 | DKL9933301009A1 Tanggal Terbit 31-12-2018 | MERSIFARMA TIRMAKU MERCUSANA - INDONESIA | MERSIFARMA TIRMAKU MERCUSANA - INDONESIA | Obat Generik |
