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 |
|---|---|---|---|---|---|---|---|---|
| 611 | Sildenafil Citrate | Kaplet Salut Selaput | 100 mg | Sildenafil Citrate | GKL1832719909A1 Tanggal Terbit 23-05-2019 | YARINDO FARMATAMA - INDONESIA | YARINDO FARMATAMA - INDONESIA | Obat Generik |
| 612 | Sildenafil Citrate | Oral Dissolving Film | 70241 | Ericfil 50 | DKL2233554519A1 Tanggal Terbit 12-04-2022 | ETERCON PHARMA - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 613 | Sildenafil Citrate | Kaplet Salut Selaput | 140,48 mg | Zifagra | DKL2009226209A1 Tanggal Terbit 16-02-2021 | IFARS PHARMACEUTICAL LABORATORIES - INDONESIA | IFARS PHARMACEUTICAL LABORATORIES - INDONESIA | Obat Generik |
| 614 | Sildenafil Citrate | Tablet salut selaput | 140,48 mg | Camastil | DKL2143501917A1 Tanggal Terbit 20-06-2021 | AMAROX PHARMA GLOBAL - INDONESIA | AMAROX PHARMA GLOBAL - INDONESIA | Obat Generik |
| 615 | Sildenafil Citrate | Tablet Salut Selaput | 140,5 mg | Amigra 100 | DKL2138601017A1 Tanggal Terbit 06-12-2021 | SATRIA BUMIKERTA - AMIDA FARMA - Indonesia | SATRIA BUMIKERTA - AMIDA FARMA - Indonesia | Obat Generik |
| 616 | Simvastatin, Ezetimibe | Kaplet | 20 mg, 10 mg | Ezetatin | DKL1907923604A1 Tanggal Terbit 17-11-2019 | HARSEN - INDONESIA | HARSEN - INDONESIA | Obat Generik |
| 617 | Sofosbuvir | Tablet salut selaput | 400 mg | Hepcinat | DKI1849500117A1 Tanggal Terbit 08-03-2019 | NATCO PHARMA LIMITED - INDIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 618 | Sofosbuvir | Tablet salut selaput | 400 mg | Sobuvir | DKI1746800117A1 Tanggal Terbit 09-05-2018 | STRIDES SHASUN LIMITED-INDIA | BERNOFARM - INDONESIA | Obat Generik |
| 619 | Sofosbuvir | Tablet salut selaput | 400 mg | Sofohep | DKI2025601017A1 Tanggal Terbit 26-09-2020 | AUROBINDO PHARMA LIMITED - INDIA | INDOFARMA - INDONESIA | Obat Generik |
| 620 | Sofosbuvir/ Ledispavir Premix | Tablet salut selaput | 400 mg/ 180 mg | Lisof | DKI2018603117A1 Tanggal Terbit 25-02-2020 | HETERO LABS LIMITED - INDIA | AMAROX PHARMA GLOBAL - INDONESIA | Obat Generik |
