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 |
|---|---|---|---|---|---|---|---|---|
| 1 | Acetylsalicylic Acid | Tablet | 300 mg | Bayer Aspirin | Filipina | Bayer Bitterfeld GmbH OT Greppin – Germany] | Bayer Phils., Inc | - |
| 2 | Alendronate sodium | Tablet | 70 mg | Fosamax | USA | - | Merck And Co Inc | - |
| 3 | Amitriptylline | Tablet | 10 mg; 25 mg;75 mg | Tryptizol | Italy | - | (Merck Sharp & Dohme, Lda. Atau Frosst Iberica, S.A.) Italy | - |
| 4 | Amitriptylline | Tablet | 10 mg; 50 mg; 75 mg; 100 mg; 150 mg | Amitriptylline Hydrochloride | USA | - | Sandoz Inc | - |
| 5 | Amoxicillin | Kapsul | 500 mg | Amoxil | Singapore | Smithkline Beecham Limited (UK); Glaxo Wellcome Production (FR) | Glaxosmithkline Pte Ltd | - |
| 6 | Artemether (kombinasi dengan Lumefantrine) | Tablet | 20 mg/120 mg | Riamet | Malaysia | - | Novartis Corporation (Malaysia) Sdn. Bhd | - |
| 7 | Artesunate | - | - | Arsumax Arsuamoon | - | - | Sanofi F Guilin Pharmaceuticals (China) | - |
| 8 | Atenolol | Tablet | 100 mg | Tenormin | Malaysia | Astrazeneca UK Limited | Astrazeneca | - |
| 9 | Carvedilol | Tablet | 25 mg | Dilatrend | Malaysia | Delpharm Milano S.R.L, Italy | DKSH Malaysia SDN BHD | - |
| 10 | Cefdinir | Kapsul | 300 mg | Cefdinir | USA | - | Sandoz Inc | - |
LIST OF GENERIC DRUGS THAT HAVE MEET THE BIOECIVALENCE CRITERIA IN 2022
| No | ZAT AKTIF | BENTUK SEDIAAN | KEKUATAN | NAMA DAGANG | NIE | PRODUSEN | PENDAFTAR | STATUS |
|---|---|---|---|---|---|---|---|---|
| 501 | Mycophenolate Mofetil | Tablet salut selaput | 500 mg | Mycocell | DKI1953400117A1 Tanggal Terbit 23-08-2019 | ALKEM LABORATORIES LIMITED-INDIA | PHAPROS - INDONESIA | Obat Generik |
| 502 | Mycophenolate Mofetil | Kaplet Salut Selaput | 500 mg | Kamyfet | DKL1811645409A1 Tanggal Terbit 30-01-2019 | KALBE FARMA - INDONESIA | KALBE FARMA - INDONESIA | Obat Generik |
| 503 | Mycophenolate Mofetil | Kaplet Salut Selaput | 500 mg | Celmunos | DKI2055900109A1 Tanggal Terbit 02-08-2020 | CONCORD BIOTECH LTD. - INDIA | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Generik |
| 504 | Mycophenolate Sodium | Tablet Salut Enterik | 384,70 mg | Mycophen 360 | DKI2055900215B1 Tanggal Terbit 19-09-2020 | CONCORD BIOTECH LTD. - INDIA | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Generik |
| 505 | Nebivolol Hydrochloride | Tablet | 5 mg | Nebivolol | GKL2033550010A1 Tanggal Terbit 04-10-2020 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 506 | Nebivolol Hydrochloride | Tablet | 5,450 mg | Linoven | DKL2033550110A1 Tanggal Terbit 04-10-2020 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 507 | Nifedipine | Tablet pelepasan Lambat | 10 mg | Farmalat ER | DKL8831500314A1 Tanggal Terbit 16-12-2019 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 508 | Nomegestrol Acetate | Tablet Salut Selaput | 5 mg | Prodefi | DKL2133553417A1 Tanggal Terbit 10-12-2021 | ETERCON PHARMA - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 509 | Ofloxacin | Tablet salut selaput | 400 mg | Akilen 400 | DKL9522213017B1 Tanggal Terbit 31-12-2018 | SANBE FARMA - INDONESIA | SANBE FARMA - INDONESIA | Obat Generik |
| 510 | Ofloxacin | Tablet salut selaput | 400 mg | Ofloxacin | GKL0005029617B1 Tanggal Terbit 08-04-2022 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
