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 |
|---|---|---|---|---|---|---|---|---|
| 61 | Captopril | Tablet | 50 mg | Captopril | GKL9705023010C1 Tanggal Terbit 01-11-2018 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Komparator |
| 62 | Carbamazepine | Tablet | 200 mg | Tegretol | DKL9930410310A1 Tanggal Terbit 08-06-2021 | NOVARTIS INDONESIA - INDONESIA | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 63 | Cefditoren Pivoxil | Tablet Salut Selaput | 200 mg | Meiact 200 | DKI0665600217A1 Tanggal Terbit 23-12-2020 | MEIJI PHARMA SPAIN, S.A - Spain | MEIJI INDONESIAN PHARMACEUTICAL INDUSTRIES - Indonesia | Obat Komparator |
| 64 | Cefixime Trihydrate | Kapsul | 100 mg | Cefspan | DKL9211616501B1 Tanggal Terbit 27-01-2021 | DANKOS FARMA - INDONESIA LISENSI DARI OTSUKA CHEMICAL CO LTD - JAPAN | KALBE FARMA - INDONESIA | Obat Komparator |
| 65 | Cefixime Trihydrate | Kaplet Salut Selaput | 200 mg | Cefspan | DKL0311636509A1 Tanggal Terbit 21-07-2019 | DANKOS FARMA LISENSI ASTELLAS PHARMA INC., - JAPAN | KALBE FARMA - INDONESIA | Obat Komparator |
| 66 | Cefixime Trihydrate | Sirup Kering | 120,67 mg | Cefspan | DKL9211616738A1 Tanggal Terbit 05-07-2020 | DANKOS FARMA LISENSI OTSUKA CHEMICAL CO., LTD. - JAPAN | KALBE FARMA - INDONESIA | Obat Komparator |
| 67 | Cefuroxime Axetil | Tablet Salut Selaput | 250 mg | Zinnat | DKI9775700517B1 Tanggal Terbit 22-03-2022 | GLAXO OPERATIONS UK LTD - ENGLAND | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 68 | Cefuroxime Axetil | Tablet Salut Selaput | 500 mg | Zinnat | DKI9775700517C1 Tanggal Terbit 22-03-2022 | GLAXO WELLCOME AUSTRALIA PTY LTD, AUSTRALIA | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 69 | Celecoxib | Kapsul | 200 mg | Celebrex | DKL2019809701B1 Tanggal Terbit 24-02-2020 | PFIZER PHARMACEUTICALS LLC - USA | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 70 | Celecoxib | Kapsul | 100 mg | Celebrex | DKL1919809701A1 Tanggal Terbit 24-02-2020 | PFIZER PHARMACEUTICALS LLC - USA | 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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|---|
| 21 | Aciclovir | Tablet | 200 mg | Aciclovir | GKL9832703710A1 Tanggal Terbit 02-01-2020 | YARINDO FARMATAMA - INDONESIA | YARINDO FARMATAMA - INDONESIA | Obat Generik |
| 22 | Alprazolam | Tablet | 1 mg | Alprazolam | GPL1312426710B1 Tanggal Terbit 05-10-2018 | KIMIA FARMA - INDONESIA | KIMIA FARMA - INDONESIA | Obat Generik |
| 23 | Alprazolam | Tablet | 1 mg | Alprazolam | GPL0405036610C1 Tanggal Terbit 26-03-2019 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 24 | Alprazolam | Tablet | 1 mg | Alganax-1 | DPL9908012310C1 Tanggal Terbit 01-09-2020 | GUARDIAN PHARMATAMA - INDONESIA | GUARDIAN PHARMATAMA - INDONESIA | Obat Generik |
| 25 | Alprazolam | Tablet | 1 mg | Atarax-1 | DPL1633313210A1 Tanggal Terbit 23-01-2018 | MERSIFARMA TIRMAKU MERCUSANA - INDONESIA | MERSIFARMA TIRMAKU MERCUSANA - INDONESIA | Obat Generik |
| 26 | Alprazolam | Tablet | 1 mg | Calmlet | DPL9931806610C1 Tanggal Terbit 12-11-2018 | SUNTHI SEPURI - INDONESIA | SUNTHI SEPURI - INDONESIA | Obat Generik |
| 27 | Alprazolam | Tablet | 1 mg | Zypraz | DPL0111632810C1 Tanggal Terbit 25-10-2018 | KALBE FARMA - INDONESIA | KALBE FARMA - INDONESIA | Obat Generik |
| 28 | Alprazolam | Tablet | 1 mg | Zolysan 1 | DPL1922256704A1 Tanggal terbit 15-02-2021 | SANBE FARMA (UNIT 1) - INDONESIA | SANBE FARMA - INDONESIA | Obat Generik |
| 29 | Alprazolam | Kaplet | 1 mg | Zolastin | DPL2035310310A1 Tanggal Terbit 23-03-2021 | GRACIA PHARMINDO - INDONESIA | GRACIA PHARMINDO - INDONESIA | Obat Generik |
| 30 | Ambroxol Hydrochloride | Tablet | 75 mg | Amvalcon | DKL2015721314A1 Tanggal Terbit 14-10-2020 | NOVELL PHARMACEUTICAL LAB - INDONESIA | ETERCON PHARMA - INDONESIA | Obat Generik |
