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 |
|---|---|---|---|---|---|---|---|---|
| 81 | Clobazam | Tablet pelepasan lambat | 10 mg | Frisium | DPL0121203810A1 Tanggal Terbit 01-08-2018 | AVENTIS PHARMA INDONESIA | AVENTIS PHARMA -NDONESIA | Obat Komparator |
| 82 | Clodronate Disodium | Kapsul | 400 mg | Bonefos | DKI0775601101A1 Tanggal Terbit 04-01-2018 | BAYER SCHERING PHARMA OY - FINLAND | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 83 | Clodronate Disodium | Tablet Salut Selaput | 800 mg | Bonefos | DKI0775601217A1 Tanggal Terbit 04-01-2018 | BAYER SCHERING PHARMA OY - FINLAND | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 84 | Clopidogrel | Tablet Salut Selaput | 97,875 mg | Plavix | DKL1321205717A1 Tanggal Terbit 04-08-2019 | AVENTIS PHARMA - INDONESIA | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 85 | Clopidogrel | Tablet Salut Selaput | 391,5 mg | Plavix | DKI1377403617B1 Tanggal Terbit 18-03-2022 | SANOFI- WINTHROP - PERANCIS | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 86 | Cyproterone Acetate/ Ethinyl Estradiol | Tablet Salut Gula | 2 mg/ 0,035 mg | Diane 35 | DKI0868204416A1 Tanggal Terbit 30-08-2022 | BAYER WEIMAR GMBH UND CO. KG - Federal Republic of Germany | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 87 | Dabigatran Etexilate Mesilate | Kapsul | 110 mg | Pradaxa | DKI0952502201B1 Tanggal Terbit 23-10-2018 | BOEHRINGER INGELHEIM WEST GERMANY | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 88 | Dabigatran Etexilate Mesilate | Kapsul | 75 mg | Pradaxa | DKI0952502201A1 Tanggal Terbit 23-10-2018 | BOEHRINGER INGELHEIM WEST GERMANY | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 89 | Dabigatran Etexilate Mesilate | Kapsul | 172,95 mg | Pradaxa | DKI1152502201C1 Tanggal Terbit 04-10-2020 | BOEHRINGER INGELHEIM WEST GERMANY | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 90 | Dapaglifozin | Tablet Salut Selaput | 10 mg | Forxiga | DKI1735301317B1 Tanggal terbit 22-03-2018 | ASTRAZENECA INDONESIA - INDONESIA | ASTRAZENECA UK LIMITED | 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 |
|---|---|---|---|---|---|---|---|---|
| 51 | Ketoconazole | Tablet | 200 mg | Ketoconazole | USA | - | TARO PHARMACEUTICAL INDUSTRIES LTD | - |
| 52 | Ketoprofen | Tablet pelepasan lambat | 150 mg | Bi-Profenid | Poland | - | Sanofi-Aventis | - |
| 53 | Ketoprofen | Kapsul pelepasan lambat | 200 mg | Profenid LP 200 | France; Austria | - | Sanofi-Aventis, France; Sanofi-Aventis, Austria | - |
| 54 | Ketoprofen | Kapsul | 50 mg | Profenid | France; Austria | - | Sanofi-Aventis, France; Sanofi-Aventis, Austria | - |
| 55 | Ketoprofen | Tablet salut selaput | 100 mg | Profenid | France; Austria | - | Sanofi-Aventis, France; Sanofi-Aventis, Austria | - |
| 56 | Lansoprazole | Kapsul lepas tunda | 30 mg | Takepron atau Prevacid | Australia, USA, UK | - | Takeda Teva atau Takeda | - |
| 57 | Lenalidomide | Kapsul | 25 mg | Revlimid | Malaysia, USA | - | Celgene International Switzerlan (MY); Celgene Corp (US) | - |
| 58 | Levodopa (kombinasi Carbidopa) | Tablet | 200 mg/50 mg | Sinemet CR | Singapore | - | ORGANON SINGAPORE PTE. LTD. | - |
| 59 | Levodopa (kombinasi Carbidopa) | Tablet | 200 mg/50 mg | Sinemet CR | Australia | - | ORGANON PHARMA PTY LTD | - |
| 60 | Lisinopril | Tablet | Lisinopril 5 mg; 10 mg; 20 mg | Zestril | Malaysia, Philippines, Australia | Aztrazeneca Pharmaceutical Co. Ltd, China (MY, PH) | AstraZeneca Pharmaceutical | - |
LIST OF GENERIC DRUGS THAT HAVE MEET THE BIOECIVALENCE CRITERIA IN 2022
| No | ZAT AKTIF | BENTUK SEDIAAN | KEKUATAN | NAMA DAGANG | NIE | PRODUSEN | PENDAFTAR | STATUS |
|---|---|---|---|---|---|---|---|---|
| 121 | Cefixime Trihydrate | Kapsul | 100 mg | Nucef | DKL0808014601A1 Tanggal Terbit 05-10-2018 | DARYA VARIA LABORATORIA - INDONESIA | GUARDIAN PHARMATAMA - INDONESIA | Obat Generik |
| 122 | Cefixime Trihydrate | Kapsul | 100 mg | Lafsefik 100 | DKL2043800301A1 Tanggal Terbit 14-08-2020 | LEMBAGA FARMASI ANGKATAN UDARA ROOSTYAN EFFENDIE - INDONESIA | LEMBAGA FARMASI ANGKATAN UDARA ROOSTYAN EFFENDIE - INDONESIA | Obat Generik |
| 123 | Cefixime Trihydrate | Kapsul | 200 mg | Starcef | DKL0605040501A1 Tanggal Terbit 26-07-2020 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 124 | Cefixime Trihydrate | Kapsul | 200 mg | Cefixime | GKL0933521201B1 Tanggal Terbit 29-12-2017 | ETERCON PHARMA - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 125 | Cefixime Trihydrate | Kapsul | 200 mg | Cefila | DKL0813314001A1 Tanggal Terbit 29-03-2018 | LAPI - INDONESIA | LAPI - INDONESIA | Obat Generik |
| 126 | Cefixime Trihydrate | Kapsul | 200 mg | Nixaven 200 | DKL1033522101B1 Tanggal Terbit 17-11-2020 | ETERCON PHARMA - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 127 | Cefixime Trihydrate | Kapsul | 200 mg | Profim | DKL2133217201A1 Tanggal Terbit 18-03-2022 | PROMEDRAHARDJO FARMASI INDUSTRI - Indonesia | PROMEDRAHARDJO FARMASI INDUSTRI - INDONESIA | Obat Generik |
| 128 | Cefixime Trihydrate | Kaplet Salut Selaput | 200 mg | Fixacep 200 | DKL9731515917A1 Tanggal Terbit 14-10-2022 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 129 | Cefixime Trihydrate | Kaplet Salut Selaput | 200 mg | Sporetik | DKL1622254309A1 Tanggal Terbit 20-09-2017 | SANBE FARMA - INDONESIA | SANBE FARMA - INDONESIA | Obat Generik |
| 130 | Cefixime Trihydrate | Kaplet Salut Selaput | 200 mg | Anfix | DKL0913705109A1 Tanggal Terbit 22-04-2021 | DARYA VARIA LABORATORIA TBK PLANT CITEUREUP - INDONESIA | MAHAKAM BETA FARMA - INDONESIA | Obat Generik |
