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 |
|---|---|---|---|---|---|---|---|---|
| 11 | Allopurinol | Tablet | 100 mg | Zyloric | DKL9932004210A1 Tanggal Terbit 21-01-2019 | GLAXO WELLCOME INDONESIA - INDONESIA | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 12 | Alprazolam | Kaplet | 0,25 mg | Xanax | DPI1054200604A1 Tanggal Terbit 30-10-2020 | PFIZER ITALIA S.R.L - ITALY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 13 | Alprazolam | Kaplet | 0,5 mg | Xanax | DPI1054200604B1 Tanggal Terbit 30-10-2020 | PFIZER ITALIA S.R.L - ITALY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 14 | Alprazolam | Kaplet | 1 mg | Xanax | DPI1054200604C1 Tanggal Terbit 30-10-2020 | PFIZER ITALIA S.R.L - ITALY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 15 | Amiodarone | Tablet | 200 mg | Cordarone | DKL1421205810A1 Tanggal Terbit 21-10-2021 | AVENTIS PHARMA - INDONESIA | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 16 | Amlodipine Besilate | Tablet | 5 mg | Norvask | DKL9219803410A1 Tanggal Terbit 08-10-2018 | PFIZER INDONESIA - INDONESIA | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 17 | Amlodipine Besilate | Tablet | 10 mg | Norvask | DKL9619803410B1 Tanggal Terbit 08-10-2018 | PFIZER INDONESIA - INDONESIA | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 18 | Amlodipine Besilate/ Valsartan | Tablet Salut Selaput | 5 mg/ 80 mg | Exforge 5/80 | DKI2197301017A1 Tanggal Terbit 09-09-2021 | SIEGFRIED BARBERA, S.L. - SPAIN | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 19 | Amlodipine Besilate/ Valsartan | Tablet Salut Selaput | 5 mg/ 160 mg | Exforge 5/160 | DKI2197301017B1 Tanggal Terbit 09-09-2021 | SIEGFRIED BARBERA, S.L. - SPAIN | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 20 | Amlodipine Besilate/ Valsartan | Tablet Salut Selaput | 10 mg/160 mg | Exforge 10/160 | DKI2197301017C1 Tanggal Terbit 09-09-2021 | 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 |
|---|---|---|---|---|---|---|---|---|
| 661 | Zolpidem Tartrate | Tablet salut selaput | 10 mg | Zolmia | DPL0331523217A1 Tanggal Terbit 09-09-2021 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 662 | Zolpidem Tartrate | Tablet salut selaput | 10 mg | Zolta | DPL1233526617A1 Tanggal Terbit 23-06-2022 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
