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 |
|---|---|---|---|---|---|---|---|---|
| 31 | Apixaban | Tablet Salut Selaput | 5 mg | Eliquis | DKI2190702117B1 Tanggal Terbit 22-04-2021 | PFIZER IRELAND PHARMACEUTICALS - Ireland | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 32 | Aripiprazole | Orally Disintegrating Tablet | 15 mg | Abilify Discmelt | DKI1509700681B1 Tanggal Terbit 17-06-2021 | KOREA OTSUKA PHARMACEUTICAL - REPUBLIC OF KOREA | OTSUKA INDONESIA - INDONESIA | Obat Komparator |
| 33 | Aripiprazole | Orally Disintegrating Tablet | 10 mg | Abilify Discmelt | DKI1509700681A1 Tanggal Terbit 17-06-2021 | KOREA OTSUKA PHARMACEUTICAL - REPUBLIC OF KOREA | OTSUKA INDONESIA - INDONESIA | Obat Komparator |
| 34 | Aripiprazole | Tablet | 10 mg | Abilify | DKI0409700110A1 Tanggal Terbit 22-04-2020 | KOREA OTSUKA PHARMACEUTICAL - REPUBLIC OF KOREA | OTSUKA INDONESIA - INDONESIA | Obat Komparator |
| 35 | Aripiprazole | Tablet | 15 mg | Abilify | DKI0409700110B1 Tanggal Terbit 22-04-2020 | KOREA OTSUKA PHARMACEUTICAL - REPUBLIC OF KOREA | OTSUKA INDONESIA - INDONESIA | Obat Komparator |
| 36 | Aripiprazole | Tablet | 5 mg | Abilify | DKI0809700110DI Tanggal Terbit 28-03-2018 | KOREA OTSUKA PHARMACEUTICAL - REPUBLIC OF KOREA | OTSUKA INDONESIA - INDONESIA | Obat Komparator |
| 37 | Atorvastatin Calcium Trihydrate | Tablet Salut Selaput | 10 mg | Lipitor | DKI9790700217A1 Tanggal Terbit 03-06-2022 | PFIZER PHARMACEUTICALS LLC, VEGA BAJA, UNITED STATES OF AMERICA Dikemas dan Dirilis Oleh PFIZER MANUFACTURING DEUTSCHLAND GMBH, FREIBURG, FEDERAL REPUBLIC OF GERMANY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 38 | Atorvastatin Calcium Trihydrate | Tablet Salut Selaput | 80 mg | Lipitor | DKI1790700217D1 Tanggal Terbit 10-01-2021 | PFIZER PHARMACEUTICALS LLC, VEGA BAJA, UNITED STATES OF AMERICA Dikemas dan Dirilis Oleh PFIZER MANUFACTURING DEUTSCHLAND GMBH, FREIBURG, FEDERAL REPUBLIC OF GERMANY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 39 | Atorvastatin Calcium Trihydrate | Tablet Salut Selaput | 40 mg | Lipitor | DKI9790700217C1 Tanggal Terbit 07-06-2022 | PFIZER PHARMACEUTICALS LLC, VEGA BAJA, UNITED STATES OF AMERICA Dikemas dan Dirilis Oleh PFIZER MANUFACTURING DEUTSCHLAND GMBH, FREIBURG, FEDERAL REPUBLIC OF GERMANY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 40 | Atorvastatin Calcium Trihydrate | Tablet Salut Selaput | 20 mg | Lipitor | DKI9790700217B1 Tanggal Terbit 03-06-2022 | PFIZER PHARMACEUTICALS LLC, VEGA BAJA, UNITED STATES OF AMERICA Dikemas dan Dirilis Oleh PFIZER MANUFACTURING DEUTSCHLAND GMBH, FREIBURG, FEDERAL REPUBLIC OF GERMANY | PFIZER 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 |
|---|---|---|---|---|---|---|---|---|
| 61 | Loratadine/ Pseudoephedrine | Tablet | 5 mg/ 120 mg | Clarityn-D 12Hour Repetabs | Singapore | - | Bayer | - |
| 62 | Lovastatin | Tablet lepas lambat | 20,40 dan 60 mg | Altoprev | USA | - | COVIS PHARMA GMBH | - |
| 63 | Lynestrenol | Tablet | 0,5 mg | Exluton | Philippines | NV Organon Netherland | Merck Sharp & Dohme | - |
| 64 | Medroxy progesterone acetate | Injeksi Depo | 150 mg/mL | DEPO PROVERA | USA | - | Pfizer Inc | - |
| 65 | Megestrol Acetate | Suspensi | 125 mg/ml | Megace ES | USA | - | ENDO PHARMACEUTICALS INC | - |
| 66 | Meloxicam | Tablet | 15 mg; 7,5 mg | Mobic | Australia, Singapore, EU | Boehringer Ingelheim | - | - |
| 67 | Methotrexate | Tablet | 2,5 mg | Methotrexate Sodium | USA | - | Hikma Pharmaceuticals USA Inc | - |
| 68 | Methotrexate | Tablet | 15 mg | Trexall | USA | - | Barr Laboratories Inc | - |
| 69 | Methyldopa | Tablet | 250 mg | Aldomet | Australia | - | Aspen Pharmacare Australia Pty Ltd | - |
| 70 | Methylphenidate | Tablet | 10 mg | Ritalin | Malaysia | - | NOVARTIS FARMACEUTICA S.A., SPAIN | - |
LIST OF GENERIC DRUGS THAT HAVE MEET THE BIOECIVALENCE CRITERIA IN 2022
| No | ZAT AKTIF | BENTUK SEDIAAN | KEKUATAN | NAMA DAGANG | NIE | PRODUSEN | PENDAFTAR | STATUS |
|---|---|---|---|---|---|---|---|---|
| 41 | Apixaban | Tablet Salut Selaput | 5 mg | Apigat | DKI2249501017B1 Tanggal Terbit 04-06-2022 | NATCO PHARMA LIMITED - India | DIPA PHARMALAB INTERSAINS - INDONESIA | Obat Generik |
| 42 | Apixaban | Tablet Salut Selaput | 5 mg | Aprixa | DKI2218604517A1 Tanggal Terbit 10-03-2022 | HETERO LABS LIMITED - India | AMAROX PHARMA GLOBAL - INDONESIA | Obat Generik |
| 43 | Apixaban | Tablet Salut Selaput | 5 mg | Brixa | DKL2205065717A1 Tanggal Terbit 03-10-2022 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 44 | Aripiprazole | Tablet | 10 mg | Arpizol | DKL2243502810C1 Tanggal Terbit 28-01-2022 | AMAROX PHARMA GLOBAL - Indonesia | AMAROX PHARMA GLOBAL - INDONESIA | Obat Generik |
| 45 | Aripiprazole | Tablet | 15 mg | Avram | DKL1721646610C1 Tanggal Terbit 18-12-2017 | PHAROS INDONESIA - INDONESIA | PHAROS INDONESIA - INDONESIA | Obat Generik |
| 46 | Aripiprazole | Tablet Cepat Larut | 15 mg | Aripiprazole | GKL1605051482B1 Tanggal Terbit 27-02-2018 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 47 | Aripiprazole | Kaplet | 10 mg | Zonia - 10 | DKL1808025604A1 Tanggal Terbit 08-05-2019 | GUARDIAN PHARMATAMA - INDONESIA | GUARDIAN PHARMATAMA - INDONESIA | Obat Generik |
| 48 | Aripiprazole | Tablet | 10 mg | Arinia - 10 | DKL1615624410B1 Tanggal Terbit 23-03-2021 | MEPROFARM - INDONESIA | MEPROFARM - INDONESIA | Obat Generik |
| 49 | Aripiprazole | Tablet | 5 mg | Arpizol 5 | DKL2243502810A1 Tanggal Terbit 28-01-2022 | AMAROX PHARMA GLOBAL - Indonesia | AMAROX PHARMA GLOBAL - INDONESIA | Obat Generik |
| 50 | Aripiprazole | Tablet | 10 mg | Aripiprazole | GKL2144403410A1 Tanggal Terbit 01-11-2021 | KIMIA FARMA Tbk. - Indonesia | KIMIA FARMA Tbk. - Indonesia | Obat Generik |
