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 |
|---|---|---|---|---|---|---|---|---|
| 61 | Captopril | Tablet | 50 mg | Captopril | GKL9705023010C1 Tanggal Terbit 01-11-2018 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Komparator |
| 62 | Carbamazepine | Tablet | 200 mg | Tegretol | DKL9930410310A1 Tanggal Terbit 08-06-2021 | NOVARTIS INDONESIA - INDONESIA | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 63 | Cefditoren Pivoxil | Tablet Salut Selaput | 200 mg | Meiact 200 | DKI0665600217A1 Tanggal Terbit 23-12-2020 | MEIJI PHARMA SPAIN, S.A - Spain | MEIJI INDONESIAN PHARMACEUTICAL INDUSTRIES - Indonesia | Obat Komparator |
| 64 | Cefixime Trihydrate | Kapsul | 100 mg | Cefspan | DKL9211616501B1 Tanggal Terbit 27-01-2021 | DANKOS FARMA - INDONESIA LISENSI DARI OTSUKA CHEMICAL CO LTD - JAPAN | KALBE FARMA - INDONESIA | Obat Komparator |
| 65 | Cefixime Trihydrate | Kaplet Salut Selaput | 200 mg | Cefspan | DKL0311636509A1 Tanggal Terbit 21-07-2019 | DANKOS FARMA LISENSI ASTELLAS PHARMA INC., - JAPAN | KALBE FARMA - INDONESIA | Obat Komparator |
| 66 | Cefixime Trihydrate | Sirup Kering | 120,67 mg | Cefspan | DKL9211616738A1 Tanggal Terbit 05-07-2020 | DANKOS FARMA LISENSI OTSUKA CHEMICAL CO., LTD. - JAPAN | KALBE FARMA - INDONESIA | Obat Komparator |
| 67 | Cefuroxime Axetil | Tablet Salut Selaput | 250 mg | Zinnat | DKI9775700517B1 Tanggal Terbit 22-03-2022 | GLAXO OPERATIONS UK LTD - ENGLAND | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 68 | Cefuroxime Axetil | Tablet Salut Selaput | 500 mg | Zinnat | DKI9775700517C1 Tanggal Terbit 22-03-2022 | GLAXO WELLCOME AUSTRALIA PTY LTD, AUSTRALIA | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 69 | Celecoxib | Kapsul | 200 mg | Celebrex | DKL2019809701B1 Tanggal Terbit 24-02-2020 | PFIZER PHARMACEUTICALS LLC - USA | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 70 | Celecoxib | Kapsul | 100 mg | Celebrex | DKL1919809701A1 Tanggal Terbit 24-02-2020 | PFIZER PHARMACEUTICALS LLC - USA | PFIZER 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 |
|---|---|---|---|---|---|---|---|---|
| 201 | Clozapine | Tablet | 25 mg | Nuzip 25 | DKL1030815910A1 Tanggal Terbit 23-12-2020 | GUARDIAN PHARMATAMA - INDONESIA | GUARDIAN PHARMATAMA - INDONESIA | Obat Generik |
| 202 | Cyproterone Acetate/ Ethinyl Estradiol | Tablet Salut Selaput | 2 mg/ 0,035 mg | Neynna | DKL0831904217A1 Tanggal Terbit 27-08-2019 | TRIYASA NAGAMAS FARMA | TRIYASA NAGAMAS FARMA | Obat Generik |
| 203 | Cyproterone Acetate/ Ethinyl Estradiol | Tablet Salut Gula | 2 mg/ 0,035 mg | Eva | DKL1607921216A1 Tanggal Terbit 11-01-2018 | HARSEN - INDONESIA | HARSEN - INDONESIA | Obat Generik |
| 204 | Cyproterone acetate/ Ethinylestradiol | Tablet Salut Selaput | 2 mg/ 0,035 mg | Elzsa | DKL2018605417A1 Tanggal Terbit 15-09-2020 | SYDNA FARMA - INDONESIA | SYDNA FARMA - INDONESIA | Obat Generik |
| 205 | Cyproterone acetate/ Ethinylestradiol | Tablet Salut Selaput | 2 mg/ 0,035 mg | Cyprodiol | DKL2031547017A1 Tanggal terbit 29-06-2021 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 206 | Daclatasvir Dihydrochloride | Tablet Salut Selaput | 65,919 mg | Natdac 60 | DKI1949500217B1 Tanggal Terbit 23-05-2019 | NATCO PHARMA LIMITED - INDIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 207 | Daclatasvir Dihydrochloride | Tablet Salut Selaput | 66 mg | Dasvir 60 | DKI1918602717A1 Tanggal Terbit 01-10-2019 | HETERO LABS LIMITED - INDIA | AMAROX PHARMA GLOBAL - INDONESIA | Obat Generik |
| 208 | Dapagliflozin/ Metformin Hydrochloride | Tablet salut selaput | 10 mg/ 500 mg | Diagliflozmet XR | DKI2154801117C1 Tanggal Terbit 20-06-2021 | MACLEODS PHARMACEUTICALS LIMITED - INDIA | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Generik |
| 209 | Dapagliflozin/ Metformin Hydrochloride | Tablet salut selaput | 10 mg/ 1000 mg | Diagliflozmet XR | DKI2154801117D1 Tanggal Terbit 20-06-2021 | MACLEODS PHARMACEUTICALS LIMITED - INDIA | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Generik |
| 210 | Deferasirox | Tablet Dispersible | 500 mg | Kalsirox | DKL1904430481B1 Tanggal Terbit 28-05-2019 | KALBE FARMA - INDONESIA | DANKOS FARMA - INDONESIA | Obat Generik |
