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 |
|---|---|---|---|---|---|---|---|---|
| 161 | Furosemide | Tablet Salut Selaput | 40 mg | Lasix | DKL0121203710A1 Tanggal Terbit 31-12-2018 | AVENTIS PHARMA - INDONESIA | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 162 | Gabapentin | Kapsul | 300 mg | Neurontin | DKI9590700101B1 Tanggal Terbit 18-01-2018 | PFIZER MANUFACTURING DEUTSCHLAND GMBH - GERMANY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 163 | Gefitinib | Tablet salut selaput | 250 mg | Iressa | DKI1235300217A1 Tanggal Terbit 01-10-2019 | NIPRO PHARMA CORPORATION - JAPAN | ASTRAZENECA - INDONESIA | Obat Komparator |
| 164 | Glibenclamide | Tablet | 5 mg | Daonil | DKL0121203910A1 Tanggal Terbit 19-03-2018 | AVENTIS PHARMA - INDONESIA | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 165 | Glibenclamide/ Metformin HCl | Tablet Salut Selaput | 5 mg/ 500 mg | Glucovance | DKL1715809217C1 Tanggal Terbit 06-12-2021 | MERCK INDONESIA TBK - INDONESIA | MERCK SHARP & DOHME PHARMA - INDONESIA | Obat Komparator |
| 166 | Glibenclamide/ Metformin HCl | Tablet Salut Selaput | 2,5 mg/ 500 mg | Glucovance | DKL1715809217B1 Tanggal Terbit 06-12-2021 | MERCK INDONESIA TBK - INDONESIA | MERCK INDONESIA TBK - INDONESIA | Obat Komparator |
| 167 | Glibenclamide/ Metformin HCl | Tablet Salut Selaput | 5 mg/ 1000 mg | Glucovance | DKI1801600117D1 Tanggal Terbit 07-05-2019 | MERCK SANTE SAS - PERANCIS | MERCK INDONESIA TBK - INDONESIA | Obat Komparator |
| 168 | Glibenclamide/ Metformin HCl | Tablet Salut Selaput | 1,25 mg/ 250 mg | Glucovance | DKL1715809217A1 Tanggal Terbit 06-12-2021 | MERCK INDONESIA TBK - INDONESIA | MERCK INDONESIA TBK - INDONESIA | Obat Komparator |
| 169 | Gliclazide | Tablet | 80 mg | Diamicron | DKL1604524910A1 Tanggal Terbit 11-04-2022 | DARYA VARIA LABORATORIA, INDONESIA LISENSI DARI LES LABORATORIES SERVIER - FRANCE | DARYA VARIA LABORATORIA - INDONESIA | Obat Komparator |
| 170 | Gliclazide | Tablet lepas lambat | 60 mg | Diamicron MR | DKI1768601214A1 Tanggal Terbit 12-04-2022 | LES LABORATORIES SERVIER - FRANCE | 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 |
|---|---|---|---|---|---|---|---|---|
| 141 | Cefuroxime Axetil | Kaplet Salut Selaput | 500 mg | Cefuroxime Axetil | GKL1905062909A1 Tanggal Terbit 22-09-2019 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 142 | Cefuroxime Axetil | Kaplet Salut Selaput | 500 mg | Anbacim | DKL9222212709B1 Tanggal Terbit 19-10-2020 | SANBE FARMA - INDONESIA | SANBE FARMA - INDONESIA | Obat Generik |
| 143 | Celecoxib | Kapsul | 200 mg | Celcox 200 | DKL2031547201B1 Tanggal Terbit 13-08-2020 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 144 | Celecoxib | Kapsul | 200 mg | Celecoxib | GKL1943003801B1 Tanggal Terbit 23-12-2020 | GUARDIAN PHARMATAMA - INDONESIA | NULAB PHARMACEUTICAL INDONESIA | Obat Generik |
| 145 | Cilostazol | Tablet | 50 mg | Aggravan | DKL0205031310A1 Tanggal Terbit 01-04-2021 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 146 | Cilostazol | Tablet | 100 mg | Naletal- 100 | DKL0308013110B1 Tanggal Terbit 25-04-2020 | GUARDIAN PHARMATAMA, TANGERANG - INDONESIA | GUARDIAN PHARMATAMA - INDONESIA | Obat Generik |
| 147 | Cilostazol | Tablet | 100 mg | Cilostazol | GKL0502337810A1 Tanggal Terbit 25-11-2020 | BERNOFARM - INDONESIA | BERNOFARM - INDONESIA | Obat Generik |
| 148 | Cilostazol | Tablet | 100 mg | Citaz 100 | DKL0104418410B11 Tanggal Terbit 07-04-2022 | DANKOS FARMA - Indonesia | DANKOS FARMA - Indonesia | Obat Generik |
| 149 | Ciprofloxacin | Tablet Lepas Lambat | 1000 mg | Civell MR | DKL1633535814A1 Tanggal Terbit 11-01-2019 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 150 | Ciprofloxacin | Tablet Salut Selaput | 500 mg | Mensipox | DKL9615609017A1 Tanggal Terbit 01-08-2018 | MEPROFARM - INDONESIA | MEPROFARM - INDONESIA | Obat Generik |
