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 |
|---|---|---|---|---|---|---|---|---|
| 361 | Valaciclovir HCl | Tablet Salut Selaput | 500 mg | Valtrex | DKI1691601017A1 Tanggal Terbit 02-05-2020 | GLAXO WELLCOME SA - SPAIN | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 362 | Valganciclovir HCl | Tablet Salut Selaput | 496,3 mg | Valcyte | DKI1011600217A1 Tanggal Terbit 24-04-2020 | PATHEON INC - CANADA | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 363 | Valsartan | Tablet Salut Selaput | 80 mg | Diovan | DKI2197301217A1 Tanggal Terbit 11-10-2021 | SIEGFRIED BARBERA, S.L. - Spain | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 364 | Valsartan | Tablet Salut Selaput | 160 mg | Diovan | DKI2197301217B1 Tanggal Terbit 11-10-2021 | SIEGFRIED BARBERA, S.L. - Spain | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 365 | Vardenafil HCl Trihydrate | Tablet Salut Selaput | 10 mg | Levitra | DKI0351601917B1 Tanggal Terbit 28-12-2018 | BAYER PHARMA AG, LEVERKUSEN - GERMANY | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 366 | Vardenafil HCl Trihydrate | Tablet Salut Selaput | 20 mg | Levitra | DKI0351601917C1 Tanggal Terbit 28-12-2018 | BAYER PHARMA AG, LEVERKUSEN - GERMANY | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 367 | Venlafaxine HCl | Kapsul Lepas Lambat | 75 mg | Efexor XR | DKI1191400603A1 Tanggal Terbit 27-01-2021 | PFIZER IRELAND PHARMACEUTICALS - IRELAND | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 368 | Verapamil | Tablet Salut Selaput | 80 mg | Isoptin | DKL0200202717A1 Tanggal Terbit 15-07-2019 | ABBOTT INDONESIA-INDONESIA DENGAN LISENSI ABBOTT LABORATORIES - UNITED STATES OF AMERICA | ABBOTT INDONESIA - INDONESIA | Obat Komparator |
| 369 | Verapamil | Kaplet Pelepasan Lambat | 240 mg | Isoptin SR | DKL1900207497A1 Tanggal Terbit 16-10-2019 | ABBOTT INDONESIA - INDONESIA | ABBOTT INDONESIA - INDONESIA | Obat Komparator |
| 370 | Vildagliptin | Tablet | 50 mg | Galvus | DKI1697300610A1 Tanggal Terbit 24-05-2022 | SIEGFRIED BARBERA, S.L. - Spain | NOVARTIS 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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
