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 |
|---|---|---|---|---|---|---|---|---|
| 121 | Entacapone/ Levodopa/ Cabidopa | Tablet Salut Selaput | 200/75/20,25 mg | Stalevo | DKI2180901417A1 Tanggal Terbit 22-02-2021 | ORION OYJ ORIO CORPORATION ORION PHARMA - FINLAND | IMEDCO DJAJA -INDONESIA | Obat Komparator |
| 122 | Entacapone/ Levodopa/ Cabidopa | Tablet Salut Selaput | 200/125/33 mg | Stalevo | DKI2180901417C1 Tanggal Terbit 22-02-2021 | ORION OYJ ORIO CORPORATION ORION PHARMA - FINLAND | IMEDCO DJAJA -INDONESIA | Obat Komparator |
| 123 | Erlotinib | Tablet Salut Selaput | 150 mg | Tarceva | DKI1857507717B1 Tanggal Terbit 31-12-2018 | ROCHE SPA SEGRATE - ITALY | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 124 | Erlotinib | Tablet Salut Selaput | 100 mg | Tarceva | DKI1857507717A1 Tanggal Terbit 31-12-2018 | DELPHARM LILE S.A.S- FRANCE | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 125 | Escitalopram | Tablet Salut Selaput | 5 mg | Cipralex | DKI1299900417A1 Tanggal Terbit 21-10-2021 | H. LUNDBECK A/S - DENMARK | PYRIDAM FARMA - INDONESIA | Obat Komparator |
| 126 | Escitalopram | Tablet Salut Selaput | 10 mg | Cipralex | DKI1299900417B1 Tanggal Terbit 21-10-2021 | H. LUNDBECK A/S - DENMARK | PYRIDAM FARMA - INDONESIA | Obat Komparator |
| 127 | Escitalopram | Tablet Salut Selaput | 20 mg | Cipralex | DKI1299900417C1 Tanggal Terbit 21-10-2021 | H. LUNDBECK A/S - DENMARK | PYRIDAM FARMA - INDONESIA | Obat Komparator |
| 128 | Esomeprazole Magnesium | Tablet Salut Selaput | 20 mg | Nexium MUPS | DKI1335300317A1 Tanggal Terbit 17-05-2022 | ASTRAZENECA AB - SWEDIA | ASTRAZENECA - INDONESIA | Obat Komparator |
| 129 | Esomeprazole Magnesium | Tablet Salut Selaput | 40 mg | Nexium MUPS | DKI1335300317B1 Tanggal Terbit 17-05-2022 | ASTRAZENECA AB - SWEDIA | ASTRAZENECA - INDONESIA | Obat Komparator |
| 130 | Estazolam | Tablet | 1 mg | Esilgan | DPL7825102910A1 Tanggal Terbit 17-12-2020 | TAKEDA INDONESIA - INDONESIA | TAKEDA 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 |
