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 |
|---|---|---|---|---|---|---|---|---|
| 71 | Azithromycin Dihydrate | Kaplet Salut Selaput | 500 mg | Zithrax | DKL9604413909A1 Tanggal Terbit 31-12-2018 | DANKOS FARMA - INDONESIA | DANKOS FARMA - INDONESIA | Obat Generik |
| 72 | Azithromycin Dihydrate | Kaplet Salut Selaput | 500 mg | Zarom 500 | DKL1621022509A1 Tanggal Terbit 14-08-2017 | PYRIDAM FARMA TBK - Indonesia | PYRIDAM FARMA TBK - INDONESIA | Obat Generik |
| 73 | Azithromycin Dihydrate | Kaplet Salut Selaput | 500 mg | Zitrolin | DKL1218826409A1 Tanggal Terbit 06-07-2022 | OTTO PHARMACEUTICALS INDUSTRIES - INDONESIA | OTTO PHARMACEUTICAL INDUSTRIES - INDONESIA | Obat Generik |
| 74 | Azithromycin Dihydrate | Kapsul | 250 mg | Mezatrin 250 | DKL9522216101A1 Tanggal Terbit 15-04-2020 | CAPRIFARMINDO LABORATORIES - INDONESIA | SANBE FARMA - INDONESIA | Obat Generik |
| 75 | Azithromycin Dihydrate | Kaplet Salut Selaput | 500 mg | Azomax 500 | DKL9505017109A1 Tanggal Terbit 28-08-2018 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 76 | Azithromycin Dihydrate | Tablet salut selaput | 500 mg | Azivol | DKL1333530744A1 Tanggal Terbit 14-04-2022 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 77 | Azithromycin Dihydrate | Kaplet Salut Selaput | 500 mg | Trozin 500 | DKL0922720409B1 Tanggal Terbit 25-01-2022 | TEMPO SCAN PACIFIC TBK - INDONESIA | TEMPO SCAN PACIFIC TBK - INDONESIA | Obat Generik |
| 78 | Azithromycin Dihydrate | Kaplet Salut Selaput | 524 mg | Zistic | DKL9502321309A1 Tanggal Terbit 13-08-2019 | BERNOFARM - INDONESIA | BERNOFARM - INDONESIA | Obat Generik |
| 79 | Bicalutamide | Tablet Salut Selaput | 50 mg | Calutami 50 | DKI1884400517A1 Tanggal Terbit 21-01-2019 | CHONG KUN DANG PHARMACEUTICAL - REPUBLIC OF KOREA | OTTO PHARMACEUTICAL INDUSTRIES - INDONESIA | Obat Generik |
| 80 | Bicalutamide | Tablet Salut Selaput | 50 mg | Promod 50 | DKI1935400617A1 Tanggal Terbit 12-10-2019 | INTAS PHARMACEUTICAL LTD. - INDIA | MERSIFARMA TIRMAKU MERCUSANA - INDONESIA | Obat Generik |
