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 |
|---|---|---|---|---|---|---|---|---|
| 191 | Isosorbide Dinitrate | Tablet | 10 mg | Cedocard 10 | DKL9104506710B1 Tanggal Terbit 14-02-2018 | DARYA VARIA LABORATORIA - INDONESIA DIBAWAH LISENSI TAKEDA NETHERLAND B.V, HOOFDDORP, NETHERLAND | DARYA VARIA LABORATORIA - INDONESIA | Obat Komparator |
| 192 | Isosorbide Dinitrate | Tablet Lepas Lambat | 20 mg | Cedocard Retard | DKL8304501114A1 Tanggal terbit 30-08-2018 | DARYA VARIA LABORATORIA - INDONESIA | DARYA VARIA LABORATORIA - INDONESIA | Obat Komparator |
| 193 | Isosorbide Mononitrate | Tablet Salut Selaput Lepas Lambat | 60 mg | Imdur | DKI1835301414A1 Tanggal Terbit 08-05-2019 | ASTRAZENECA PHARMACEUTICAL COMPANY LTD. | PYRIDAM FARMA - INDONESIA | Obat Komparator |
| 194 | Itraconazole | Kapsul | 100 mg | Sporanox | DKL1124402501A1 Tanggal Terbit 27-11-2020 | TAISHO PHARMACEUTICAL INDONESIA TBK, DEPOK-INDONESIA, DIBAWAH LISENSI JANSSEN PHARMACEUTICA, BEERSE, BELGIUM | TAISHO PHARMACEUTICAL INDONESIA TBK - INDONESIA | Obat Komparator |
| 195 | Ivabradine HCl | Tablet Salut Selaput | 7,5 mg | Coralan | DKI1668601317B1 Tanggal Terbit 26-01-2021 | LES LABORATORIES SERVIER - FRANCE | DARYA VARIA LABORATORIA - INDONESIA | Obat Komparator |
| 196 | Ivabradine HCl | Tablet Salut Selaput | 5 mg | Coralan | DKI1668601317A1 Tanggal Terbit 26-01-2021 | LES LABORATORIES SERVIER - FRANCE | DARYA VARIA LABORATORIA - INDONESIA | Obat Komparator |
| 197 | Ketoprofen | Suppositoria | 100 mg | Profenid | DKL0121200853A1 Tanggal Terbit 08-03-2020 | AVENTIS PHARMA - INDONESIA | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 198 | Ketoprofen | Tablet Salut Enterik | 100 mg | Profenid E-100 | DKL0121200853B1 Tanggal Terbit 03-05-2018 | AVENTIS PHARMA - INDONESIA | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 199 | Lamivudine | Tablet Salut Selaput | 150 mg | 3 TC | DKI1833900417A1 Tanggal Terbit 23-10-2018 | GLAXO WELLCOME AUSTRALIA PTY LTD, AUSTRALIA | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 200 | Lamivudine | Tablet Salut Selaput | 100 mg | 3 TC-HBV | DKI1733900317A1 Tanggal Terbit 28-08-2018 | GLAXO WELLCOME AUSTRALIA PTY LTD, AUSTRALIA | GLAXO WELLCOME 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 |
|---|---|---|---|---|---|---|---|---|
| 571 | Quetiapine Fumarate | Tablet pelepasan Lambat | 230,270 mg | Quetiapine Fumarate | GKL2043501014A1 Tanggal Terbit 19-03-2020 | AMAROX PHARMA GLOBAL - INDONESIA | AMAROX PHARMA GLOBAL - INDONESIA | Obat Generik |
| 572 | Ramipril | Tablet | 10 mg | Emerten 10 | DKL1133525010C1 Tanggal Terbit 24-10-2018 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 573 | Ramipril | Tablet | 5 mg | Ramipril | GKL1919933910A1 Tanggal Terbit 23-05-2019 | PHAPROS - INDONESIA | PHAPROS - INDONESIA | Obat Generik |
| 574 | Ramipril | Tablet | 10 mg | Hyperil | DKL0605033810D1 Tanggal Terbit 13-01-2021 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 575 | Rebamipide | Tablet Salut Selaput | 100 mg | Novepide | DKL1133524217A1 Tanggal Terbit 06-08-2021 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 576 | Rifampicin | Kaplet Salut Selaput | 600 mg | Rifamtibi | DKL8522200509A1 Tanggal Terbit 23-05-2019 | SANBE FARMA - INDONESIA | SANBE FARMA - INDONESIA | Obat Generik |
| 577 | Rifampicin/ Isoniazid | Tablet salut selaput | 150 mg/ 150 mg | Rifampicin 150 mg/ Isoniazid 150 mg | GKL0620931917A1 Tanggal Terbit 07-06-2018 | INDOFARMA - INDONESIA | INDOFARMA - INDONESIA | Obat Generik |
| 578 | Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol | Tablet salut selaput | 150 mg/ 75 mg/ 400 mg/ 275 mg | Rifampicin 150 mg/ Isoniazid 75 mg/ Pyrazinamide 400 mg/ Ethambutol 275 mg | GKL0620932009A1 Tanggal Terbit 01-08-2018 | INDOFARMA - INDONESIA | INDOFARMA - INDONESIA | Obat Generik |
| 579 | Risedronate Sodium | Tablet Salut Selaput | 35 mg | Osteonate OAW | DKL1411643509A1 Tanggal terbit 24-09-2021 | KALBE FARMA - INDONESIA | KALBE FARMA - INDONESIA | Obat Generik |
| 580 | Risperidone | Tablet salut selaput | 2 mg | Noprenia | DKL9933500217B1 Tanggal Terbit 06-05-2019 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
