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 |
|---|---|---|---|---|---|---|---|---|
| 1 | Acetylsalicylic Acid | Tablet | 300 mg | Bayer Aspirin | Filipina | Bayer Bitterfeld GmbH OT Greppin – Germany] | Bayer Phils., Inc | - |
| 2 | Alendronate sodium | Tablet | 70 mg | Fosamax | USA | - | Merck And Co Inc | - |
| 3 | Amitriptylline | Tablet | 10 mg; 25 mg;75 mg | Tryptizol | Italy | - | (Merck Sharp & Dohme, Lda. Atau Frosst Iberica, S.A.) Italy | - |
| 4 | Amitriptylline | Tablet | 10 mg; 50 mg; 75 mg; 100 mg; 150 mg | Amitriptylline Hydrochloride | USA | - | Sandoz Inc | - |
| 5 | Amoxicillin | Kapsul | 500 mg | Amoxil | Singapore | Smithkline Beecham Limited (UK); Glaxo Wellcome Production (FR) | Glaxosmithkline Pte Ltd | - |
| 6 | Artemether (kombinasi dengan Lumefantrine) | Tablet | 20 mg/120 mg | Riamet | Malaysia | - | Novartis Corporation (Malaysia) Sdn. Bhd | - |
| 7 | Artesunate | - | - | Arsumax Arsuamoon | - | - | Sanofi F Guilin Pharmaceuticals (China) | - |
| 8 | Atenolol | Tablet | 100 mg | Tenormin | Malaysia | Astrazeneca UK Limited | Astrazeneca | - |
| 9 | Carvedilol | Tablet | 25 mg | Dilatrend | Malaysia | Delpharm Milano S.R.L, Italy | DKSH Malaysia SDN BHD | - |
| 10 | Cefdinir | Kapsul | 300 mg | Cefdinir | USA | - | Sandoz Inc | - |
LIST OF GENERIC DRUGS THAT HAVE MEET THE BIOECIVALENCE CRITERIA IN 2022
| No | ZAT AKTIF | BENTUK SEDIAAN | KEKUATAN | NAMA DAGANG | NIE | PRODUSEN | PENDAFTAR | STATUS |
|---|---|---|---|---|---|---|---|---|
| 531 | Pantoprazole | Tablet salut enterik | 40 mg | Panvell | DKL1433532415A1 Tanggal Terbit 14-02-2022 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 532 | Pantoprazole | Tablet salut enterik | 40 mg | Panvell | DKL1433532415A1 Tanggal Terbit 14-02-2022 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 533 | PANTOPRAZOLE SODIUM SESQUIHYDRATE | TABLET SALUT ENTERIK | 40 mg | PANTERA 40 | DKL2143009215B1 Tanggal Terbit 07-11-2021 | GUARDIAN PHARMATAMA - INDONESIA | NULAB PHARMACEUTICAL INDONESIA | Obat Generik |
| 534 | Pentoxyfilline | Kaplet salut gula | 400 mg | Platof | DKL9822225208A1 Tanggal Terbit 23-03-2021 | SANBE FARMA (UNIT 1) - INDONESIA | SANBE FARMA - INDONESIA | Obat Generik |
| 535 | Pioglitazone | Tablet | 30 mg | Pionix 30 | DKL0904426510B1 Tanggal Terbit 31-12-2021 | DANKOS FARMA - INDONESIA | DANKOS FARMA - INDONESIA | Obat Generik |
| 536 | Pioglitazone HCl | Tablet | 30 mg | Deculin | DKL0505036810B1 Tanggal Terbit 25-01-2018 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 537 | Pioglitazone HCl | Tablet | 30 mg | Protaz 30 | DKL1313707510B1 Tanggal Terbit 25-12-2019 | MAHAKAM BETA FARMA - INDONESIA | MAHAKAM BETA FARMA - INDONESIA | Obat Generik |
| 538 | Pioglitazone HCl | Tablet | 30 mg | Opiglit | DKL1718828510B1 Tanggal Terbit 26-08-2018 | OTTO PHARMACEUTICALS INDUSTRIES - INDONESIA | OTTO PHARMACEUTICAL INDUSTRIES - INDONESIA | Obat Generik |
| 539 | Pioglitazone HCl | Tablet | 33,07 mg | Prabetic 30 | DKL1231532910B1 Tanggal Terbit 30-01-2020 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 540 | Pioglitazone HCl | Tablet | 33,070 mg | Tazovell | DKL1933544610A1 Tanggal Terbit 28-08-2020 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
