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 |
|---|---|---|---|---|---|---|---|---|
| 621 | Spironolactone | Tablet Salut Selaput | 100 mg | CARPIATON 100 | DKL9531508917C1 Tanggal Terbit 03-01-2022 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 622 | Sulfasalazine | Kaplet Salut Enterik | 500 mg | Lafazin | DKL0533515907A1 Tanggal Terbit 14-10-2020 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 623 | Sulfasalazine | Kaplet Salut Enterik | 500 mg | Sulfitis | DKL0231522815A1 Tanggal Terbit 01-07-2020 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 624 | Sulfasalazine | Kaplet Salut Enterik | 500 mg | Sulfasalazine | GKL2015721107A1 Tanggal Terbit 18-06-2020 | NOVELL PHARMACEUTICAL LAB - INDONESIA | ETERCON PHARMA - INDONESIA | Obat Generik |
| 625 | Tadalafil | Tablet salut selaput | 20 mg | Promel 20 | DKL2013322617C1 Tanggal Terbit 29-12-2020 | LAPI LABORATORIES - INDONESIA | LAPI LABORATORIES - INDONESIA | Obat Generik |
| 626 | Tamsulosin HCl | Tablet pelepasan Lambat | 0,4 mg | Farlosin SR | DKI2143401014A1 Tanggal Terbit 26-05-2021 | SYNTHON HISPANIA, S.L. - Spain | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 627 | Telmisartan | Tablet | 80 mg | Telsat | DKL1734606910B1 Tanggal Terbit 06-02-2018 | DEXA MEDICA - INDONESIA | FERRON PAR PHARMACEUTICALS - INDONESIA | Obat Generik |
| 628 | Telmisartan | Tablet | 80 mg | Tinov 80 | DKL2033549010A1 Tanggal Terbit 22-06-2020 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 629 | Telmisartan | Tablet | 80 mg | Telmiz | DKL2204530810A1 Tanggal Terbit 29-03-2022 | DARYA VARIA LABORATORIA TBK PLANT CITEUREUP - INDONESIA | DARYA VARIA LABORATORIA - INDONESIA | Obat Generik |
| 630 | Telmisartan/ Hydrochlorothiazide | Kaplet | 80 mg/ 12,5 mg | Co-Telsaril 80/12,5 | DKI1953000104A1 Tanggal Terbit 17-07-2019 | DASAN PHARMACEUTICAL CO., LTD. - KOREA | OTTO PHARMACEUTICAL INDUSTRIES - INDONESIA | Obat Generik |
