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 |
|---|---|---|---|---|---|---|---|---|
| 291 | Quetiapine Fumarate | Tablet Lepas Lambat | 150 mg | Seroquel XR | DKI1735300614E1 Tanggal Terbit 01-08-2018 | ASTRAZENECA PHARMACEUTICAL LP - USA | ASTRAZENECA - INDONESIA | Obat Komparator |
| 292 | Quetiapine Fumarate | Tablet Lepas Lambat | 200 mg | Seroquel XR | DKI1333500614B1 Tanggal Terbit 01-08-2018 | ASTRAZENECA PHARMACEUTICAL COMPANY LTD. | ASTRAZENECA - INDONESIA | Obat Komparator |
| 293 | Quetiapine Fumarate | Tablet Lepas Lambat | 300 mg | Seroquel XR | DKI1333500614C1 Tanggal Terbit 01-08-2018 | ASTRAZENECA PHARMACEUTICAL COMPANY LTD. | ASTRAZENECA - INDONESIA | Obat Komparator |
| 294 | Quetiapine Fumarate | Tablet Lepas Lambat | 400 mg | Seroquel XR | DKI1333500614D1 Tanggal Terbit 01-08-2018 | ASTRAZENECA PHARMACEUTICAL COMPANY LTD. | ASTRAZENECA - INDONESIA | Obat Komparator |
| 295 | Rabeprazole | Tablet Salut Enterik | 20 mg | Pariet | DKL1806102815B1 Tanggal Terbit 01-08-2018 | EISAI INDONESIA - INDONESIA | EISAI INDONESIA - INDONESIA | Obat Komparator |
| 296 | Rabeprazole | Tablet Salut Enterik | 10 mg | Pariet | DKL1806102815A1 Tanggal Terbit 01-08-2018 | EISAI INDONESIA - INDONESIA | EISAI INDONESIA - INDONESIA | Obat Komparator |
| 297 | Ramipril | Tablet | 5 mg | Triatec | DKL0121204010C1 Tanggal Terbit 23-03-2018 | AVENTIS PHARMA - INDONESIA | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 298 | Ramipril | Tablet | 10 mg | Triatec | DKL0521204010D1 Tanggal Terbit 26-01-2021 | AVENTIS PHARMA - INDONESIA | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 299 | Ramosetron HCl | Tablet | 0,1 mg | Nasea OD | DKI1237800110A1 Tanggal Terbit 12-10-2019 Masa Berlaku s/d 21-12-2022 | SEIKO EIYO YAKUHIN CO., LTD - JAPAN | COMBIPHAR - INDONESIA | Obat Komparator |
| 300 | Rebamipide | Tablet Salut Selaput | 100 mg | Mucosta | DKL0518707017A1 Tanggal Terbit 22-04-2021 | OTSUKA INDONESIA - INDONESIA | OTSUKA 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 |
