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 |
|---|---|---|---|---|---|---|---|---|
| 301 | Risedronate Sodium | Tablet Salut Selaput | 35 mg | Actonel Once-a-week | DKI2153900417A1 Tanggal Terbit 28-03-2021 | BALKANPHARMA-DUPNITSA AD - BULGARIA | PYRIDAM FARMA - INDONESIA | Obat Komparator |
| 302 | Risedronate Sodium | Tablet Salut Selaput | 150 mg | Actonel Once-a-month | DKI2153900317A1 Tanggal Terbit 28-03-2021 | BALKANPHARMA-DUPNITSA AD - BULGARIA | PYRIDAM FARMA - INDONESIA | Obat Komparator |
| 303 | Rivaroxaban (micronizad) | Tablet Salut Selaput | 10 mg | Xarelto | DKI0951602517A1 Tanggal Terbit 28-02-2019 | BAYER PHARMA AG, LEVERKUSEN - GERMANY | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 304 | Rivaroxaban (micronizad) | Tablet Salut Selaput | 15 mg | Xarelto | DKI1251602517B1 Tanggal Terbit 11-01-2022 | BAYER PHARMA AG, LEVERKUSEN - GERMANY | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 305 | Rivaroxaban (micronizad) | Tablet Salut Selaput | 20 mg | Xarelto | DKI1251602517C1 Tanggal Terbit 11-01-2022 | BAYER PHARMA AG, LEVERKUSEN - GERMANY | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 306 | Ropinirole HCl | Tablet Lepas Lambat | 2 mg | Requip PD 24 hour | DKI1291600614A1 Tanggal Terbit 16-06-2022 | GLAXO WELLCOME SA - SPAIN | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 307 | Ropinirole HCl | Tablet Lepas Lambat | 4 mg | Requip PD 24 hour | DKI1291600614B1 Tanggal Terbit 16-06-2022 | GLAXO WELLCOME SA - SPAIN | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 308 | Ropinirole HCl | Tablet Lepas Lambat | 8 mg | Requip PD 24 hour | DKI1291600614C1 Tanggal Terbit 16-06-2022 | GLAXO WELLCOME SA - SPAIN | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 309 | Rosuvastatin Calcium | Tablet Salut Selaput | 40 mg | Crestor | DKI1435300817D1 Tanggal Terbit 19-10-2018 | IPR PHARMACEUTICAL INC-UNITED KINGDOM | ASTRAZENECA - INDONESIA | Obat Komparator |
| 310 | Rosuvastatin Calcium | Tablet salut selaput | 20 mg | Crestor | DKI1435300817C1 Tanggal Terbit 19-10-2018 | IPR PHARMACEUTICAL INC-UNITED KINGDOM | ASTRAZENECA - 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 |
|---|---|---|---|---|---|---|---|---|
| 51 | Ketoconazole | Tablet | 200 mg | Ketoconazole | USA | - | TARO PHARMACEUTICAL INDUSTRIES LTD | - |
| 52 | Ketoprofen | Tablet pelepasan lambat | 150 mg | Bi-Profenid | Poland | - | Sanofi-Aventis | - |
| 53 | Ketoprofen | Kapsul pelepasan lambat | 200 mg | Profenid LP 200 | France; Austria | - | Sanofi-Aventis, France; Sanofi-Aventis, Austria | - |
| 54 | Ketoprofen | Kapsul | 50 mg | Profenid | France; Austria | - | Sanofi-Aventis, France; Sanofi-Aventis, Austria | - |
| 55 | Ketoprofen | Tablet salut selaput | 100 mg | Profenid | France; Austria | - | Sanofi-Aventis, France; Sanofi-Aventis, Austria | - |
| 56 | Lansoprazole | Kapsul lepas tunda | 30 mg | Takepron atau Prevacid | Australia, USA, UK | - | Takeda Teva atau Takeda | - |
| 57 | Lenalidomide | Kapsul | 25 mg | Revlimid | Malaysia, USA | - | Celgene International Switzerlan (MY); Celgene Corp (US) | - |
| 58 | Levodopa (kombinasi Carbidopa) | Tablet | 200 mg/50 mg | Sinemet CR | Singapore | - | ORGANON SINGAPORE PTE. LTD. | - |
| 59 | Levodopa (kombinasi Carbidopa) | Tablet | 200 mg/50 mg | Sinemet CR | Australia | - | ORGANON PHARMA PTY LTD | - |
| 60 | Lisinopril | Tablet | Lisinopril 5 mg; 10 mg; 20 mg | Zestril | Malaysia, Philippines, Australia | Aztrazeneca Pharmaceutical Co. Ltd, China (MY, PH) | AstraZeneca Pharmaceutical | - |
LIST OF GENERIC DRUGS THAT HAVE MEET THE BIOECIVALENCE CRITERIA IN 2022
| No | ZAT AKTIF | BENTUK SEDIAAN | KEKUATAN | NAMA DAGANG | NIE | PRODUSEN | PENDAFTAR | STATUS |
|---|---|---|---|---|---|---|---|---|
| 571 | Quetiapine Fumarate | Tablet pelepasan Lambat | 230,270 mg | Quetiapine Fumarate | GKL2043501014A1 Tanggal Terbit 19-03-2020 | AMAROX PHARMA GLOBAL - INDONESIA | AMAROX PHARMA GLOBAL - INDONESIA | Obat Generik |
| 572 | Ramipril | Tablet | 10 mg | Emerten 10 | DKL1133525010C1 Tanggal Terbit 24-10-2018 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 573 | Ramipril | Tablet | 5 mg | Ramipril | GKL1919933910A1 Tanggal Terbit 23-05-2019 | PHAPROS - INDONESIA | PHAPROS - INDONESIA | Obat Generik |
| 574 | Ramipril | Tablet | 10 mg | Hyperil | DKL0605033810D1 Tanggal Terbit 13-01-2021 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 575 | Rebamipide | Tablet Salut Selaput | 100 mg | Novepide | DKL1133524217A1 Tanggal Terbit 06-08-2021 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 576 | Rifampicin | Kaplet Salut Selaput | 600 mg | Rifamtibi | DKL8522200509A1 Tanggal Terbit 23-05-2019 | SANBE FARMA - INDONESIA | SANBE FARMA - INDONESIA | Obat Generik |
| 577 | Rifampicin/ Isoniazid | Tablet salut selaput | 150 mg/ 150 mg | Rifampicin 150 mg/ Isoniazid 150 mg | GKL0620931917A1 Tanggal Terbit 07-06-2018 | INDOFARMA - INDONESIA | INDOFARMA - INDONESIA | Obat Generik |
| 578 | Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol | Tablet salut selaput | 150 mg/ 75 mg/ 400 mg/ 275 mg | Rifampicin 150 mg/ Isoniazid 75 mg/ Pyrazinamide 400 mg/ Ethambutol 275 mg | GKL0620932009A1 Tanggal Terbit 01-08-2018 | INDOFARMA - INDONESIA | INDOFARMA - INDONESIA | Obat Generik |
| 579 | Risedronate Sodium | Tablet Salut Selaput | 35 mg | Osteonate OAW | DKL1411643509A1 Tanggal terbit 24-09-2021 | KALBE FARMA - INDONESIA | KALBE FARMA - INDONESIA | Obat Generik |
| 580 | Risperidone | Tablet salut selaput | 2 mg | Noprenia | DKL9933500217B1 Tanggal Terbit 06-05-2019 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
