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 |
|---|---|---|---|---|---|---|---|---|
| 101 | Ritonavir | Tablet | 100 mg | Norvir | Malaysia, Australia | - | Roche (Malaysia) Sdn Bhd | - |
| 102 | Roflumilast | tablet | 500 mcg | Daxas (MY) atau Daliresp (US) | Malaysia, USA | Takeda GMBH Germany (MY) | AstraZeneca Pharmaceutical | - |
| 103 | Simvastatin | Tablet | 10 mg; 20 mg dan 40 mg | Zocor | Malaysia, Philippines, Australia | Merck Sharp & Dohme Ltd, UK (MY,PH) | Merck Sharp & Dohme (MY&PHIL); Organon Pharma (AU) | - |
| 104 | Sofosbuvir | Tablet salut selaput | 400 mg | Sovaldi | Malaysia, Australia, USA | - | Gilead Sciences (US) | - |
| 105 | Spironolactone | tablet | 100 mg | Aldactone | Philippines, United Kingdom | Piramal Healthcare UK Ltd (PH) | Pfizer Inc | - |
| 106 | Tamoxifen | Tablet | 20 mg | Nolvadex | Singapore | Astrazeneca UK Ltd | Astrazeneca Singapore PTE Ltd | - |
| 107 | Tamsulosin | Kapsul | 0,4 mg | Flomax | USA | - | Sanofi Aventis US | - |
| 108 | Tenofovir disoproxil Fumarate | Tablet Salut Selaput | 300 mg | Viread | Australia, USA | - | Gilead Sciences | - |
| 109 | Theophylline | Tablet | 100 mg | Theovent | Poland | - | GlaxoSmithKline Pharmaceuticals S.A | - |
| 110 | Theophylline | Tablet prolonged release | 250 mg | Euphyllin CR | Poland | - | Takeda | - |
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 |
