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 |
|---|---|---|---|---|---|---|---|---|
| 631 | Temozolomide | Kapsul | 250 mg | Teroza | DKI2142100301B1 Tanggal Terbit 13-01-2021 | LOTUS PHARMACEUTICAL CO., LTD - TAIWAN | SOHO INDUSTRI PHARMASI - Indonesia | Obat Generik |
| 632 | Tenofovir Alafenamide Fumarate | Tablet salut selaput | 25 mg | Tafnat | DKI1949500317A1 Tanggal Terbit 17-11-2019 | NATCO PHARMA LIMITED - INDIA | FRESENIUS KABI COMBIPHAR - INDONESIA | Obat Generik |
| 633 | Tenofovir Alafenamide Fumarate | Tablet salut selaput | 28,043 mg | Hepbest | DKI2040400817A1 Tanggal Terbit 19-02-2020 | MYLAN LABORATORIES LIMITED - INDIA | INDOFARMA - INDONESIA | Obat Generik |
| 634 | Tenofovir Disoproxil Fumarate | Kaplet Salut Selaput | 300 mg | Tenofir | DKL1941400709A1 Tanggal Terbit 20-05-2019 | DIPA PHARMALAB INTERSAINS - INDONESIA | PUSPA PHARMA - INDONESIA | Obat Generik |
| 635 | Tenofovir Disoproxil Fumarate | Tablet salut selaput | 300 mg | Tenofovir Disoproxil Fumarate | GKX1340400217A1 Tanggal Terbit 08-04-2019 | MYLAN LABORATORIES LIMITED - INDIA | KIMIA FARMA - INDONESIA | Obat Generik |
| 636 | Tenofovir Disoproxil Fumarate | Kaplet Salut Selaput | 300 mg | Hepamed | DKL1702505609A1 Tanggal Terbit 22-12-2017 | DIPA PHARMALAB INTERSAINS - INDONESIA | DIPA PHARMALAB INTERSAINS - INDONESIA | Obat Generik |
| 637 | Tenofovir Disoproxil Fumarate/ Lamivudine/ dan Efavirenz | Tablet salut selaput | 300 mg/ 300 mg/ 600 mg | Telura | DKI1840400617A1 Tanggal Terbit 16-07-2018 | MYLAN LABORATORIES LIMITED - INDIA | INDOFARMA - INDONESIA | Obat Generik |
| 638 | Tenofovir/ Emtricitabine | Tablet salut selaput | 300 mg/ 200 mg | Ricovir-EM | DKL1840400517A1 Tanggal Terbit 14-09-2018 | MYLAN LABORATORIES LIMITED - INDIA | KIMIA FARMA - INDONESIA | Obat Generik |
| 639 | Terazosin HCl | Tablet | 2.374 mg | Hytroz | GKL1005044610B1 Tanggal Terbit 06-12-2021 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 640 | Theophylline | Kaplet Salut Selaput | 250 mg | Euphyllin Retard | DKL7821630809A1 Tanggal Terbit 23-05-2020 | PHAROS INDONESIA - INDONESIA | PHAROS INDONESIA - INDONESIA | Obat Generik |
