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 |
|---|---|---|---|---|---|---|---|---|
| 111 | Divalproex sodium | Tablet salut enterik | 250 mg | Depakote | DKL0400203115A1 Tanggal Terbit 01-09-2020 | ABBOTT INDONESIA-INDONESIA DENGAN LISENSI ABBOTT LABORATORIES - UNITED STATES OF AMERICA | ABBOTT INDONESIA - INDONESIA | Obat Komparator |
| 112 | Dolutegravir | Tablet | 50 mg | Tivicay | DKI1991601417A1 Tanggal Terbit 12-06-2019 | GLAXO WELLCOME SA - SPAIN | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 113 | Domperidone | Tablet Salut Selaput | 10 mg | Motilium | DKL1124401017A1 Tanggal Terbit 25-11-2020 | TAISHO PHARMACEUTICAL INDONESIA TBK - INDONESIA | TAISHO PHARMACEUTICAL INDONESIA TBK - INDONESIA | Obat Komparator |
| 114 | Donepezil HCl | Tablet Salut Selaput | 5 mg | Aricept | DKI0824400117A1 Tanggal Terbit 23-04-2018 | BORA PHARM CO. LTD - TAIWAN | EISAI INDONESIA - INDONESIA | Obat Komparator |
| 115 | Donepezil HCl | Tablet Dispersible | 5 mg | Aricept Evess | DKI1729000392C1 Tanggal Terbit 02-10-2018 | INTERTHAI PHARMACEUTICAL MANUFACTURING, THAILAND | EISAI INDONESIA - INDONESIA | Obat Komparator |
| 116 | Donepezil HCl | Tablet Orodispersible | 10 mg | Aricept Evess | DKI1029000392B1 Tanggal Terbit 06-12-2019 | BUSHU PHARMACEUTICALS LTD. - Japan Pemberi Lisensi EISAI CO., LTD. - Japan | EISAI INDONESIA - INDONESIA | Obat Komparator |
| 117 | Duloxetine HCl | Kapsul | 30 mg | Cymbalta | DKI1973402001A1 Tanggal Terbit 09-07-2021 | LILLY SA - SPANYOL | PYRIDAM FARMA - INDONESIA | Obat Komparator |
| 118 | Duloxetine HCl | Kapsul | 60 mg | Cymbalta | DKI1973402001B1 Tanggal Terbit 16-07-2021 | LILLY SA - SPANYOL | PYRIDAM FARMA - INDONESIA | Obat Komparator |
| 119 | Dutasteride | Kapsul lunak | 0,5 mg | Avodart | DKI1333900102A1 Tanggal Terbit 29-03-2018 | GLAXO SMITHKLINE PHARMACEUTICAL S.A - POLAND | SMITH KLINE BEECHAM PHARMACEUTICAL IND. - INDONESIA | Obat Komparator |
| 120 | Dydrogesterone | Tablet Salut Selaput | 10 mg | Duphaston | DKI1081601317A1 Tanggal Terbit 01-09-2020 | ABBOTT BIOLOGICALS B.V - NETHERLANDS | ABBOTT 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 |
