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 |
|---|---|---|---|---|---|---|---|---|
| 71 | Cholecalciferol | Kapsul Lunak | 5000 IU | Tride | DKL2002507102A1 Tanggal terbit 26 September 2020 | DIPA PHARMALAB INTERSAINS - INDONESIA | DIPA PHARMALAB INTERSAINS - INDONESIA | Obat Komparator |
| 72 | Cholecalciferol | Tablet kunyah | 5000 IU | HI-D5000 | DKL1909504363B1 Tanggal terbit 02 Maret 2020 | IMEDCO DJAJA - INDONESIA | IMEDCO DJAJA - INDONESIA | Obat Komparator |
| 73 | Ciclosporin | Kapsul Lunak | 100 mg | Sandimmun Neoral | DKI1921001202C1 Tanggal Terbit 07-06-2020 | CATALENT GERMANY EBERBACH GMBH - FEDERAL REPUBLIC OF GERMANY | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 74 | Ciclosporin | Kapsul Lunak | 50 mg | Sandimmun Neoral | DKI1921001202B1 Tanggal Terbit 07-06-2020 | CATALENT GERMANY EBERBACH GMBH - FEDERAL REPUBLIC OF GERMANY | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 75 | Ciclosporin | Kapsul Lunak | 25 mg | Sandimmun Neoral | DKI1921001202A1 Tanggal Terbit 07-06-2020 | CATALENT GERMANY EBERBACH GMBH - FEDERAL REPUBLIC OF GERMANY | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 76 | Cilostazol | Tablet | 50 mg | Pletaal | DKL0318706110A1 Tanggal Terbit 26-05-2021 | OTSUKA INDONESIA - INDONESIA pemberi lisensi OTSUKA PHARMACEUTICAL CO., LTD TOKYO JAPAN - Japan | OTSUKA INDONESIA - INDONESIA | Obat Komparator |
| 77 | Cilostazol | Tablet | 100 mg | Pletaal | DKL0318706110B1 Tanggal Terbit 26-05-2021 | OTSUKA INDONESIA - INDONESIA pemberi lisensi OTSUKA PHARMACEUTICAL CO., LTD TOKYO JAPAN - Japan | OTSUKA INDONESIA - INDONESIA | Obat Komparator |
| 78 | Ciprofibrate | Kaplet | 100 mg | Modalim | DKL1321205604A1 Tanggal Terbit 01-08-2018 | AVENTIS PHARMA - INDONESIA | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 79 | Ciprofloxacin HCl | Tablet Salut Selaput | 500 mg | Ciproxin | DKL1902009617A1 Tanggal Terbit 12-04-2019 | BAYER INDONESIA - INDONESIA | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 80 | Clarithromycin | Tablet Lepas Lambat | 500 mg | Abbotic XL | DKI0075500414A1 Tanggal Terbit 30-01-2018 | ABBOTT INDONESIA - INDONESIA | ABBOTT 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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|---|
| 11 | Aciclovir | Tablet | 400 mg | Matrovir | DKL0513022610A1 Tanggal Terbit 17-11-2021 | KONIMEX - INDONESIA | KONIMEX - INDONESIA | Obat Generik |
| 12 | Aciclovir | Tablet | 400 mg | Samclovir | DKL0823410310A1 Tanggal Terbit 29-07-2021 | SAMPHARINDO PERDANA - INDONESIA | SAMPHARINDO PERDANA - INDONESIA | Obat Generik |
| 13 | Aciclovir | Tablet | 400 mg | Clinovir | DKL9321614310B1 Tanggal Terbit 30-03-2020 | PHAROS INDONESIA - INDONESIA | PHAROS INDONESIA - INDONESIA | Obat Generik |
| 14 | Aciclovir | Tablet | 400 mg | Acifar 400 | DKL0509207204B1 Tanggal Terbit 22-04-2019 | IFARS PHARMACEUTICAL LABORATORIES - INDONESIA | IFARS PHARMACEUTICAL LABORATORIES - INDONESIA | Obat Generik |
| 15 | Aciclovir | Tablet | 400 mg | Aciclovir | GKL0433510110B1 Tanggal Terbit 29-08-2019 | ETERCON PHARMA - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 16 | Aciclovir | Tablet | 400 mg | Aciclovir | GKL1132703710B1 Tanggal Terbit 23-10-2018 | YARINDO FARMATAMA - INDONESIA | YARINDO FARMATAMA - INDONESIA | Obat Generik |
| 17 | Aciclovir | Tablet | 400 mg | Aciclovir | GKL9812415010B1 Tanggal Terbit 15-09-2020 | KIMIA FARMA - INDONESIA | KIMIA FARMA - INDONESIA | Obat Generik |
| 18 | Aciclovir | Tablet | 400 mg | Aciclovir | GKL0108504810B1 Tanggal Terbit 17-11-2021 | HEXPHARM JAYA LABORATORIES - INDONESIA | HEXPHARM JAYA LABORATORIES - INDONESIA | Obat Generik |
| 19 | Aciclovir | Tablet | 200 mg | Aciclovir | GKL9812415010A1 Tanggal Terbit 27-12-2021 | KIMIA FARMA - INDONESIA | KIMIA FARMA - INDONESIA | Obat Generik |
| 20 | Aciclovir | Tablet | 200 mg | Aciclovir | GKL9832703710A1 Tanggal Terbit 02-01-2020 | YARINDO FARMATAMA - INDONESIA | YARINDO FARMATAMA - INDONESIA | Obat Generik |
