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 |
|---|---|---|---|---|---|---|---|---|
| 341 | Telmisartan/ Amlodipin | Tablet | 80/ 10 mg | Twynsta | DKI2124200210D1 Tanggal Terbit 27-01-2021 | CIPLA LIMITED - INDIA | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 342 | Telmisartan/ Hydrochlorothiazide | Tablet | 80/ 12,5 mg | Micardis Plus | DKI2055200110A1 Tanggal Terbit 15-04-2020 | BOEHRINGER INGELHEIM ELLAS A.E - GREECE | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 343 | Telmisartan/ Hydrochlorothiazide | Tablet | 80/ 12,5 mg | Micardis Plus | DKI2055200110B1 Tanggal Terbit 15-04-2020 | BOEHRINGER INGELHEIM ELLAS A.E - GREECE | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 344 | Temozolomide | Kapsul | 20 mg | Temodal | DKI0287100901B1 Tanggal Terbit 18-08-2021 | ORION CORPORATION - FINLAND | ORGANON PHARMA INDONESIA TBK - INDONESIA | Obat Komparator |
| 345 | Temozolomide | Kapsul | 100 mg | Temodal | DKI0287100901C1 Tanggal Terbit 18-08-2021 | ORION CORPORATION - FINLAND | ORGANON PHARMA INDONESIA TBK - INDONESIA | Obat Komparator |
| 346 | Tenofovir Alafenamide Fumarate | Tablet Salut Selaput | 30 mg | Vemlidy | DKI1844200417A1 Tanggal Terbit 24-01-2019 | PATHEON INC - CANADA | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Komparator |
| 347 | Terazosin | Tablet | 2 mg | Hytrin | DKI9975500310B1 Tanggal Terbit 14-09-2018 | AESICA QUEENBOROUGH LTD - INGGRIS | ABBOTT INDONESIA - INDONESIA | Obat Komparator |
| 348 | Terazosin | Tablet | 1 mg | Hytrin | DKI9975500310A1 Tanggal Terbit 14-09-2018 | AESICA QUEENBOROUGH LTD - INGGRIS | ABBOTT INDONESIA - INDONESIA | Obat Komparator |
| 349 | Terbutaline Sulfate | Serbuk inhaler | 0,5 mg/dosis | Bricasma Turbuhaler | DKI1851303467A1 Tanggal Terbit 24-02-2020 | ASTRAZENECA PHARMACEUTICALS - SWEDEN | ASTRAZENECA - INDONESIA | Obat Komparator |
| 350 | Thiamazole | Tablet Salut Selaput | 5 mg | Thyrozol | DKI0063401417A2 Tanggal Terbit 19-04-2022 | MERCK HEALTHCARE KGAA - FEDERAL REPUBLIC OF GERMANY | MERCK TBK - 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 |
|---|---|---|---|---|---|---|---|---|
| 591 | Rosuvastatin Calcium | Tablet salut selaput | 40 mg | Rosuvastatin Calcium | GKL1943500317C1 Tanggal Terbit 12-10-2019 | AMAROX PHARMA GLOBAL - INDONESIA | AMAROX PHARMA GLOBAL - INDONESIA | Obat Generik |
| 592 | Rosuvastatin Calcium | Tablet salut selaput | 20 mg | Vastrol | DKL1621646117A1 Tanggal Terbit 16-09-2022 | PHAROS INDONESIA - INDONESIA | PHAROS INDONESIA - INDONESIA | Obat Generik |
| 593 | Rosuvastatin Calcium | Tablet salut selaput | 20 mg | Rosufer | DKL2034615417B1 Tanggal Terbit 14-04-2020 | PHARMASCIENCE INC. - CANADA | FERRON PAR PHARMACEUTICALS - INDONESIA | Obat Generik |
| 594 | Rosuvastatin Calcium | Tablet salut selaput | 20 mg | Recansa | DKL1321205417A1 Tanggal Terbit 08-11-2018 | AVENTIS INDONESIA PHARMA - INDONESIA | AVENTIS INDONESIA PHARMA - INDONESIA | Obat Generik |
| 595 | Rosuvastatin Calcium | Tablet salut selaput | 20 mg | Rosuvastatin Calcium | GKL1705057717B1 Tanggal Terbit 22-06-2018 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 596 | Rosuvastatin Calcium | Tablet salut selaput | 20 mg | Rostin 20 | DKL1713320517B1 Tanggal Terbit 09-04-2018 | LAPI - INDONESIA | LAPI - INDONESIA | Obat Generik |
| 597 | Rosuvastatin Calcium | Tablet salut selaput | 20,8 mg | Rosuvastatin Calcium | GKL2044401617A1 Tanggal Terbit 14-08-2020 | KIMIA FARMA - INDONESIA | KIMIA FARMA - INDONESIA | Obat Generik |
| 598 | Rosuvastatin Calcium | Tablet salut selaput | 21,4 mg | Rovastar | DKL1917627917A1 Tanggal Terbit 26-09-2019 | INTERBAT - INDONESIA | INTERBAT - INDONESIA | Obat Generik |
| 599 | Rosuvastatin Calcium | Tablet salut selaput | 20,838 mg | Giventor 20 | DKL1918218117B1 Tanggal Terbit 28-08-2020 | NUFARINDO - INDONESIA | NUFARINDO - INDONESIA | Obat Generik |
| 600 | Rosuvastatin Calcium | Tablet Salut Selaput | 20 mg | Pyfaros 20 | DKL2121028717B1 Tanggal Terbit 27-05-2022 | PYRIDAM FARMA TBK - Indonesia | PYRIDAM FARMA TBK - INDONESIA | Obat Generik |
