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 |
|---|---|---|---|---|---|---|---|---|
| 11 | Aciclovir | Tablet | 400 mg | Matrovir | DKL0513022610A1 Tanggal Terbit 17-11-2021 | KONIMEX - INDONESIA | KONIMEX - INDONESIA | Obat Generik |
| 12 | Aciclovir | Tablet | 400 mg | Samclovir | DKL0823410310A1 Tanggal Terbit 29-07-2021 | SAMPHARINDO PERDANA - INDONESIA | SAMPHARINDO PERDANA - INDONESIA | Obat Generik |
| 13 | Aciclovir | Tablet | 400 mg | Clinovir | DKL9321614310B1 Tanggal Terbit 30-03-2020 | PHAROS INDONESIA - INDONESIA | PHAROS INDONESIA - INDONESIA | Obat Generik |
| 14 | Aciclovir | Tablet | 400 mg | Acifar 400 | DKL0509207204B1 Tanggal Terbit 22-04-2019 | IFARS PHARMACEUTICAL LABORATORIES - INDONESIA | IFARS PHARMACEUTICAL LABORATORIES - INDONESIA | Obat Generik |
| 15 | Aciclovir | Tablet | 400 mg | Aciclovir | GKL0433510110B1 Tanggal Terbit 29-08-2019 | ETERCON PHARMA - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 16 | Aciclovir | Tablet | 400 mg | Aciclovir | GKL1132703710B1 Tanggal Terbit 23-10-2018 | YARINDO FARMATAMA - INDONESIA | YARINDO FARMATAMA - INDONESIA | Obat Generik |
| 17 | Aciclovir | Tablet | 400 mg | Aciclovir | GKL9812415010B1 Tanggal Terbit 15-09-2020 | KIMIA FARMA - INDONESIA | KIMIA FARMA - INDONESIA | Obat Generik |
| 18 | Aciclovir | Tablet | 400 mg | Aciclovir | GKL0108504810B1 Tanggal Terbit 17-11-2021 | HEXPHARM JAYA LABORATORIES - INDONESIA | HEXPHARM JAYA LABORATORIES - INDONESIA | Obat Generik |
| 19 | Aciclovir | Tablet | 200 mg | Aciclovir | GKL9812415010A1 Tanggal Terbit 27-12-2021 | KIMIA FARMA - INDONESIA | KIMIA FARMA - INDONESIA | Obat Generik |
| 20 | Aciclovir | Tablet | 200 mg | Aciclovir | GKL9832703710A1 Tanggal Terbit 02-01-2020 | YARINDO FARMATAMA - INDONESIA | YARINDO FARMATAMA - INDONESIA | Obat Generik |
