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 |
|---|---|---|---|---|---|---|---|---|
| 211 | Deferasirox | Tablet Dispersible | 500 mg | Dextron | DKL1933547781A1 Tanggal Terbit 10-12-2019 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 212 | Deferasirox | Tablet Dispersible | 500 mg | Enferox | DKI2160700181A1 Tanggal Terbit 21-10-2021 | ILKO ILAC SAN. VE TIC.A.S. - Turkey | DIPA PHARMALAB INTERSAINS - INDONESIA | Obat Generik |
| 213 | Deferiprone | Tablet Salut Selaput | 500 mg | Oferlod | DKL1733539417A1 Tanggal Terbit 08-03-2019 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 214 | Deferiprone | Tablet Salut Selaput | 500 mg | Deferiprone | GKL1805061617A1 Tanggal Terbit 23-05-2019 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 215 | Deferiprone | Kaplet Salut Selaput | 500 mg | Durafer | DKL2131548109A1 Tanggal Terbit 16-07-2021 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 216 | Desloratadine | Tablet Salut Selaput | 5 mg | Delogista | DKL2232409317A1 Tanggal Terbit 06-10-2022 | CAPRIFARMINDO LABORATORIES - Indonesia | SANBE FARMA (UNIT 1) - Indonesia | Obat Generik |
| 217 | Desloratadine | Tablet Salut Selaput | 5 mg | Desloratadine | GKL1631538217A1 Tanggal Terbit 2 -05- 2018 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 218 | Desloratadine | Tablet Salut Selaput | 5 mg | Desloratadine | GKL1705056517A1 Tanggal Terbit 07-05-2019 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 219 | Desogestrel | Tablet | 0,075 mg | Desirett | DKI1738100317A1 Tanggal Terbit 30-10-2017 | LABORATORIES LEON FARMA S. A., SPANYOL | NUFARINDO - INDONESIA | Obat Generik |
| 220 | Diacerein | Kapsul | 50 mg | Nocel | DKL1433531401A1 Tanggal Terbit 26-07-2020 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
