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 |
|---|---|---|---|---|---|---|---|---|
| 181 | Hyoscine Butylbromide | Tablet Salut Gula | 10 mg | Buscopan | DKL1821207716A1 Tanggal Terbit 05-09-2018 | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 182 | Hyoscine Butylbromide/ Paracetamol | Tablet Salut Selaput | 500/ 10 mg | Buscopan Plus | DKL1821207817A1 Tanggal Terbit 05-10-2018 | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 183 | Ibandronic acid | Tablet Salut Selaput | 150 mg | Bonviva | DKI2053100417A1 Tanggal Terbit 22-07-2021 | PENN PHARMACEUTICAL SERVICES LTD - UK DIKEMAS OLEH WAYMADE PLC, BASILDON, UK ATAS DASAR LISENSI DARI ATNAHS PHARMA UK LIMITED, BASILDON, UK | NUFARINDO - Indonesia | Obat Komparator |
| 184 | Imatinib | Tablet Salut Selaput | 100 mg | Glivec | DKI2121001417A1 Tanggal Terbit 28-03-2021 | NOVARTIS PHARMA GMBH - GERMANY | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 185 | Imatinib | Tablet Salut Selaput | 400 mg | Glivec | DKI2221001417B1 Tanggal Terbit 16-08-2022 | NOVARTIS PHARMA PRODUKTIONS GMBH - Federal Republic of Germany | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 186 | Imidapril | Tablet | 10 mg | Tanapress 10 | DKL9725201210C1 Tanggal Terbit 01-03-2019 | TANABE INDONESIA, INDONESIA DENGAN LISENSI MITSUBHI TANABE PHARMA CORP, JAPAN | TANABE INDONESIA - INDONESIA | Obat Komparator |
| 187 | Indapamide/ Perindopril | Tablet Salut Selaput | 5 mg/ 1,25 mg | Bioprexum Plus | DKI1631600517A1 Tanggal Terbit 19-09-2021 | SERVIER INDUSTRIE LTD. - IRLANDIA | DARYA VARIA LABORATORIA - INDONESIA | Obat Komparator |
| 188 | Irbesartan | Tablet Salut Selaput | 300 mg | Aprovel | DKI1077402717C1 Tanggal Terbit 22-07-2021 | SANOFI- WINTHROP - PERANCIS | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 189 | Irbesartan | Tablet Salut Selaput | 150 mg | Aprovel | DKI1077402717B1 Tanggal Terbit 22-07-2021 | SANOFI- WINTHROP - PERANCIS | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 190 | Isosorbide Dinitrate | Tablet | 5 mg | Cedocard 5 | DKL7204520210A1 Tanggal terbit 23-10-2018 | DARYA VARIA LABORATORIA - INDONESIA | DARYA VARIA LABORATORIA - 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 |
|---|---|---|---|---|---|---|---|---|
| 541 | Pitavastatin Calcium | Tablet salut selaput | 2 mg | Vitor | DKL1805060117A1 Tanggal Terbit 28-02-2019 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 542 | Pramipexole | Tablet pelepasan Lambat | 0,375 mg | Pramifrol ER | DKI2054800714A1 Tanggal Terbit 22-06-2020 | MACLEODS PHARMACEUTICALS LIMITED - INDIA | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Generik |
| 543 | Pravastatin Sodium | Tablet | 20 mg | Pravastatin Sodium | GKL2105065210B1 Tanggal Terbit 18-05-2022 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 544 | Pravastatin Sodium | Tablet | 20 mg | Pravastatin Sodium | GKL2105065210B1 Tanggal Terbit 18-05-2022 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 545 | Pregabalin | Kapsul | 75 mg | Prelin 75 | DKL1613712201A1 Tanggal Terbit 17-07-2021 | MAHAKAM BETA FARMA - INDONESIA | MAHAKAM BETA FARMA - INDONESIA | Obat Generik |
| 546 | Pregabalin | Kapsul | 75 mg | Nomathic | DKL1704526201A1 Tanggal terbit 02-02-2018 | DARYA VARIA LABORATORIA - INDONESIA | DARYA VARIA LABORATORIA - INDONESIA | Obat Generik |
| 547 | Pregabalin | Kapsul | 150 mg | Pregabalin 150 | GKL1405049701B1 Tanggal Terbit 25-12-2019 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 548 | Pregabalin | Kapsul | 150 mg | Pregabalin | GKL1533533601B1 Tanggal Terbit 12-10-2016 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 549 | Pregabalin | Kapsul | 300 mg | Aprion | DKL1021634301C1 Tanggal Terbit 22-01-2018 | PHAROS INDONESIA - INDONESIA | PHAROS INDONESIA - INDONESIA | Obat Generik |
| 550 | Pregabalin | Kapsul | 150 mg | Gabatrop | DKL1926013101B1 Tanggal Terbit 22-07-2019 | TROPICA MAS - INDONESIA | TROPICA MAS - INDONESIA | Obat Generik |
