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 |
|---|---|---|---|---|---|---|---|---|
| 201 | Clozapine | Tablet | 25 mg | Nuzip 25 | DKL1030815910A1 Tanggal Terbit 23-12-2020 | GUARDIAN PHARMATAMA - INDONESIA | GUARDIAN PHARMATAMA - INDONESIA | Obat Generik |
| 202 | Cyproterone Acetate/ Ethinyl Estradiol | Tablet Salut Selaput | 2 mg/ 0,035 mg | Neynna | DKL0831904217A1 Tanggal Terbit 27-08-2019 | TRIYASA NAGAMAS FARMA | TRIYASA NAGAMAS FARMA | Obat Generik |
| 203 | Cyproterone Acetate/ Ethinyl Estradiol | Tablet Salut Gula | 2 mg/ 0,035 mg | Eva | DKL1607921216A1 Tanggal Terbit 11-01-2018 | HARSEN - INDONESIA | HARSEN - INDONESIA | Obat Generik |
| 204 | Cyproterone acetate/ Ethinylestradiol | Tablet Salut Selaput | 2 mg/ 0,035 mg | Elzsa | DKL2018605417A1 Tanggal Terbit 15-09-2020 | SYDNA FARMA - INDONESIA | SYDNA FARMA - INDONESIA | Obat Generik |
| 205 | Cyproterone acetate/ Ethinylestradiol | Tablet Salut Selaput | 2 mg/ 0,035 mg | Cyprodiol | DKL2031547017A1 Tanggal terbit 29-06-2021 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 206 | Daclatasvir Dihydrochloride | Tablet Salut Selaput | 65,919 mg | Natdac 60 | DKI1949500217B1 Tanggal Terbit 23-05-2019 | NATCO PHARMA LIMITED - INDIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 207 | Daclatasvir Dihydrochloride | Tablet Salut Selaput | 66 mg | Dasvir 60 | DKI1918602717A1 Tanggal Terbit 01-10-2019 | HETERO LABS LIMITED - INDIA | AMAROX PHARMA GLOBAL - INDONESIA | Obat Generik |
| 208 | Dapagliflozin/ Metformin Hydrochloride | Tablet salut selaput | 10 mg/ 500 mg | Diagliflozmet XR | DKI2154801117C1 Tanggal Terbit 20-06-2021 | MACLEODS PHARMACEUTICALS LIMITED - INDIA | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Generik |
| 209 | Dapagliflozin/ Metformin Hydrochloride | Tablet salut selaput | 10 mg/ 1000 mg | Diagliflozmet XR | DKI2154801117D1 Tanggal Terbit 20-06-2021 | MACLEODS PHARMACEUTICALS LIMITED - INDIA | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Generik |
| 210 | Deferasirox | Tablet Dispersible | 500 mg | Kalsirox | DKL1904430481B1 Tanggal Terbit 28-05-2019 | KALBE FARMA - INDONESIA | DANKOS FARMA - INDONESIA | Obat Generik |
