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 |
|---|---|---|---|---|---|---|---|---|
| 311 | Rosuvastatin Calcium | Tablet salut selaput | 10 mg | Crestor | DKI1435300817B1 Tanggal Terbit 19-10-2018 | IPR PHARMACEUTICAL INC-UNITED KINGDOM | ASTRAZENECA - INDONESIA | Obat Komparator |
| 312 | Rosuvastatin Calcium | Tablet salut selaput | 5 mg | Crestor | DKI1435300817A1 Tanggal Terbit 19-10-2018 | ASTRAZENECA UK LIMITED | ASTRAZENECA - INDONESIA | Obat Komparator |
| 313 | Salbutamol | Tablet | 2 mg | Ventolin | DKL9232000610A1 Tanggal Terbit 10-04-2018 | GLAXO WELLCOME INDONESIA - INDONESIA | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 314 | Salbutamol | Aerosol | 100 mcg/dosis | Ventolin Inhaler cfc free | DKI0382001939A1 Tanggal Terbit 29-10-2018 | GLAXO WELLCOME SA - SPAIN | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 315 | Salmeterol Xinafoate/ Fluticasone Propionat | Serbuk inhaler | 72,5 mg/ 100 mg | Seretide Diskus | DKI1991500167A1 Tanggal Terbit 21-01-2022 | Glaxo Wellcome Production - Evreux - France | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 316 | Salmeterol Xinafoate/ Fluticasone Propionat | Serbuk inhaler | 72,5 mg/ 250 mg | Seretide Diskus | DKI1991500167B1 Tanggal Terbit 21-01-2022 | Glaxo Wellcome Production - Evreux - France | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 317 | Salmeterol Xinafoate/ Fluticasone Propionat | Serbuk inhaler | 72,5 mg/ 500 mg | Seretide Diskus | DKI1991500167C1 Tanggal Terbit 21-01-2022 | Glaxo Wellcome Production - Evreux - France | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 318 | Saxagliptin | Tablet Salut Selaput | 5 mg | Onglyza | DKI1735301217A1 Tanggal Terbit 29-04-2019 | ASTRAZENECA PHARMACEUTICALS LP, MOUNT VERNON, AS | ASTRAZENECA - INDONESIA | Obat Komparator |
| 319 | Saxagliptin | Tablet Salut Selaput | 2,5 mg | Onglyza | DKI1835301517A1 Tanggal Terbit 19-11-2019 | BRISTOL MYERS SQUIBB SPA - ITALY | ASTRAZENECA - INDONESIA | Obat Komparator |
| 320 | Sildenafil Citrate | Tablet Salut Selaput | 25 mg | Viagra | DKI1990401417C1 Tanggal Terbit 29-03-2019 | FAREVA AMBOISE, AMBOISE - PERANCIS | 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 |
|---|---|---|---|---|---|---|---|---|
| 41 | Fluvastatin | Tablet lepas lambat | EQ 80MG BASE | Lescol XL | Malaysia, Australia | Novartis Farmaceutica S.A, Spain (MY) | Novartis | - |
| 42 | Gemfibrozil | Tablet | 600 mg | Lopid | Australia, USA | - | Pfizer Pharmaceuticals Ltd | - |
| 43 | Glipizide | Tablet | 5 mg | Minidiab | Malaysia, Australia | Pfizer Italia S.R.L (MY) | Pfizer | - |
| 44 | Hydroxychloroquine | Tablet | 200 mg | Plaquenil | Malaysia, Australia | - | Sanofi-Aventis | - |
| 45 | Indapamide | Tablet | 2.5 mg | Natrilix | Malaysia | Les Labs Servier Industrie, France | Servier Malaysia | - |
| 46 | Indapamide | Tablet pelepasan lambat | 1.5 mg | Natrilix SR | Malaysia | Les Labs Servier Industrie, France | Servier Malaysia | - |
| 47 | Isoniazid | Tablet | 50 mg; 100 mg; 200 mg | Isozid | Germany | - | Riemser Pharma GMBH | - |
| 48 | Isoniazid | Tablet | 300 mg | Isozid/Isoniazid (USA) | USFA | - | Barr Laboratories Inc | - |
| 49 | Isoniazid/Rifampicin | Tablet salut selaput | 150 mg/300 mg | Rifinah | Australia, UK, Netherland | - | Sanofi-Aventis Australia Pty Ltd (AU) Aventis Pharma Limited (UK) Genzyme Europe BV (NE) | - |
| 50 | Ivermectin | Tablet | 3 mg | Stromectol | Australia, Singapore, USA | - | Merck Sharp & Dohme | - |
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 |
