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 |
|---|---|---|---|---|---|---|---|---|
| 221 | Diclofenac sodium | Tablet Salut enterik | 50 mg | Diclofenac Sodium | GKL2134014415A1 Tanggal Terbit 06-10-2022 | NOVAPHARIN - INDONESIA | NOVAPHARIN - INDONESIA | Obat Generik |
| 222 | Diclofenac sodium | Tablet salut enterik | 50 mg | Diclofenac Sodium | GKL9819920415B1 Tanggal Terbit 22-06-2022 | PHAPROS Tbk - Indonesia | PHAPROS Tbk - Indonesia | Obat Generik |
| 223 | Diclofenac sodium | Tablet salut enterik | 50 mg | Gratheos | DKL9231103415A1 Tanggal Terbit 19-09-2019 | GRAHA FARMA - INDONESIA | GRAHA FARMA - INDONESIA | Obat Generik |
| 224 | Diclofenac sodium | Tablet salut enterik | 50 mg | Scantaren 50 | DKL0930704315B1 Tanggal Terbit 18-12-2018 | TEMPO SCAN PACIFIC TBK - INDONESIA | SUPRA FERBINDO FARMA - INDONESIA | Obat Generik |
| 225 | Diclofenac sodium | Tablet salut enterik | 50 mg | Voltadex 50 | DKL8705002715B1 Tanggal Terbit 06-12-2019 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 226 | Diclofenac sodium | Tablet Salut enterik | 50 mg | Divoltar | DKL8811606915B1 Tanggal Terbit 14-04-2020 | KALBE FARMA - INDONESIA | KALBE FARMA - INDONESIA | Obat Generik |
| 227 | Diclofenac sodium | Tablet Salut enterik | 25 mg | Flamar 25 | DKL8922209615A1 Tanggal Terbit 23-12-2021 | CAPRIFARMINDO LABORATORIES - Indonesia | SANBE FARMA - INDONESIA | Obat Generik |
| 228 | Diclofenac sodium | Tablet salut enterik | 50 mg | Flamar 50 | DKL8922209615B1 Tanggal Terbit 07-06-2022 | SANBE FARMA (UNIT 1) - Indonesia | SANBE FARMA - INDONESIA | Obat Generik |
| 229 | Diclofenac sodium | Tablet Salut enterik | 50 mg | Renadinac 50 | DKL9131503115A1 Tanggal Terbit 14-04-2020 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 230 | Diclofenac sodium | Tablet salut enterik | 50 mg | Klotaren | DKL2244404615A1 Tanggal Terbit 20-04-2022 | KIMIA FARMA Tbk. - Indonesia | KIMIA FARMA Tbk. - Indonesia | Obat Generik |
