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 |
|---|---|---|---|---|---|---|---|---|
| 331 | Tadalafil | Tablet Salut Selaput | 20 mg | Cialis | DKI1973401817D1 Tanggal Terbit 16-02-2021 | LILLY DEL CARIBE INC - USA | PYRIDAM FARMA - INDONESIA | Obat Komparator |
| 332 | Tadalafil | Tablet Salut Selaput | 10 mg | Cialis | DKI1973401817C1 Tanggal Terbit 16-02-2021 | LILLY DEL CARIBE INC - USA | PYRIDAM FARMA - INDONESIA | Obat Komparator |
| 333 | Tadalafil | Tablet Salut Selaput | 5 mg | Cialis | DKI1973401817B1 Tanggal Terbit 06-03-2020 | LILLY DEL CARIBE INC - USA | PYRIDAM FARMA - INDONESIA | Obat Komparator |
| 334 | Tadalafil | Tablet Salut Selaput | 2,5 mg | Cialis | DKI1973401817A1 Tanggal Terbit 15-03-2020 | LILLY DEL CARIBE INC - USA | PYRIDAM FARMA - INDONESIA | Obat Komparator |
| 335 | Tamsulosin | Tablet Lepas Lambat | 0,4 mg | Harnal OCAS | DKI1120100414A1 Tanggal Terbit 21-10-2021 | ASTELLAS PHARMA EUROPE B.V, BELANDA | COMBIPHAR - INDONESIA | Obat Komparator |
| 336 | Telmisartan | Tablet | 80 mg | Micardis | DKI2055200210B1 Tanggal Terbit 02-05-2020 | BOEHRINGER INGELHEIM ELLAS A.E - GREECE | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 337 | Telmisartan | Tablet | 40 mg | Micardis | DKI2055200210A1 Tanggal Terbit 02-05-2020 | BOEHRINGER INGELHEIM ELLAS A.E - GREECE | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 338 | Telmisartan/ Amlodipin | Tablet | 40/ 5 mg | Twynsta | DKI2124200210A1 Tanggal Terbit 27-01-2021 | CIPLA LIMITED - INDIA | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 339 | Telmisartan/ Amlodipin | Tablet | 40/ 10 mg | Twynsta | DKI2124200210B1 Tanggal Terbit 27-01-2021 | CIPLA LIMITED - INDIA | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 340 | Telmisartan/ Amlodipin | Tablet | 80/ 5 mg | Twynsta | DKI2124200210C1 Tanggal Terbit 27-01-2021 | CIPLA LIMITED - INDIA | BOEHRINGER INGELHEIM INDONESIA - 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 |
