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 |
|---|---|---|---|---|---|---|---|---|
| 241 | Montelukast Sodium | Tablet Kunyah | 4 mg | Singulair | DKL2106609963A1 Tanggal Terbit 21-01-2022 | ORGANON PHARMA (UK) LIMITED - United Kingdom | ORGANON PHARMA INDONESIA TBK - Indonesia | Obat Komparator |
| 242 | Moxifloxacin HCl | Tablet Salut Selaput | 400 mg | Avelox | DKI2071602017A1 Tanggal Terbit 31-10-2020 | BAYER HEALTHCARE MANUFACTURING S.R.L - Italy | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 243 | Mycophenolate Mofetil | Kaplet Salut Selaput | 500 mg | Cellcept | DKI2157510309A1 Tanggal terbit 07-10-2022 | DELPHARM MILANO S.R.L - ITALY | MENARINI INDRIA LABORATORIES - Indonesia | Obat Komparator |
| 244 | Mycophenolic Acid | Tablet Salut Enterik | 180 mg | Myfortic | DKI2121001315A1 Tanggal Terbit 26-05-2021 | NOVARTIS PHARMA GMBH - GERMANY | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 245 | Mycophenolic Acid | Tablet Salut Enterik | 360 mg | Myfortic | DKI2121001315B1 Tanggal Terbit 26-05-2021 | NOVARTIS PHARMA GMBH - GERMANY | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 246 | Nebivolol Hydrochloride | Tablet | 5 mg | Nebilet | DKI1529800210A1 Tanggal Terbit 26-08-2020 | BERLIN CHEMIE AG - GERMANY | MENARINI INDRIA LABORATORIES - INDONESIA | Obat Komparator |
| 247 | Nifedipine | Tablet Lepas Lambat | 30 mg | Adalat Oros | DKL1802009414B1 Tanggal Terbit 21-11-2018 | BAYER PHARMA AG, LEVERKUSEN - GERMANY | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 248 | Nifedipine | Tablet Lepas Lambat | 20 mg | Adalat Oros | DKL1802009414A1 Tanggal Terbit 21-11-2018 | BAYER PHARMA AG, LEVERKUSEN - GERMANY | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 249 | Nimodipine | Tablet Salut Selaput | 30 mg | Nimotop | DKL1802009517A1 Tanggal Terbit 28-02-2019 | BAYER PHARMA AG, LEVERKUSEN - GERMANY | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 250 | Norethisterone | Tablet | 5 mg | Primolut N | DKI0815900510A1 Tanggal Terbit 17-04-2019 | BAYER PHARMA AG, LEVERKUSEN - GERMANY | BAYER 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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
