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 |
|---|---|---|---|---|---|---|---|---|
| 91 | Deferasirox | Tablet Dispersible | 500 mg | Exjade | DKI0667505281A1 Tanggal Terbit 25-11-2020 | NOVARTIS PHARMA AG - SWITZERLAND | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 92 | Deferasirox | Tablet Salut Selaput | 360 | Exjade | DKI1867509517C1 Tanggal Terbit 02-09-2019 | NOVARTIS PHARMA AG - SWITZERLAND | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 93 | Deferasirox | Tablet Dispersible | 250 mg | Exjade | DKI0667505281B1 Tanggal Terbit 25-11-2020 | NOVARTIS PHARMA AG - SWITZERLAND | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 94 | Deferasirox | Tablet Dispersible | 125 mg | Exjade | DKI0667505281C1 Tanggal Terbit 25-11-2020 | NOVARTIS PHARMA AG - SWITZERLAND | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 95 | Deferasirox | Tablet Salut Selaput | 90 | Exjade | DKI1867509517A1 Tanggal Terbit 02-09-2019 | NOVARTIS PHARMA AG - SWITZERLAND | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 96 | Deferasirox | Tablet Salut Selaput | 180 | Exjade | DKI1867509517B1 Tanggal Terbit 02-09-2019 | NOVARTIS PHARMA STEIN A.G., STEIN - SWISS | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 97 | Deferiprone | Tablet Salut Selaput | 500 mg | Ferriprox | DKI1119200117A1 Tanggal Terbit 09-05-2022 | APOTEX INC., CANADA | SYDNA FARMA - INDONESIA | Obat Komparator |
| 98 | Desloratadine/ Pseudoephedrine sulfate | Tablet Lepas Lambat | 120 mg/2,5 mg | Aerius D-12 | DKI0987101714A1 Tanggal terbit 05-08-2021 | PATHEON INC., WHITBY, CANADA, DIKEMAS DAN DIRILIS OLEH SCHERING-PLOUGH LABO NV, HEIST-OP-DEN-BERG, 2220, BELGIUM | ORGANON PHARMA INDONESIA TBK - Indonesia | Obat Komparator |
| 99 | Dexketoprofen | Tablet | 25 mg | Ketesse | DKL0405036517A2 Tanggal Terbit 29-03-2018 | DEXA MEDICA - INDONESIA DENGAN LISENSI DARI MENARINI INTERNATIONAL OPERATION, GERMANY | DEXA MEDICA - INDONESIA | Obat Komparator |
| 100 | Diacerein | Kapsul | 50 mg | Artrodar | DKI0411100101A1 Tanggal Terbit 27-01-2021 | TRB CHEMEDICA INTERNATIONAL SA, SWISS TRB PHARMA S.A. - Argentina Pemberi Lisensi TRB CHEMEDICA INTERNATIONAL SA - Switzerland | COMBIPHAR - 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 |
|---|---|---|---|---|---|---|---|---|
| 491 | Moxifloxacin HCl | Tablet salut selaput | 400 mg | Moxifloxacin HCl | GKL1943500117A1 Tanggal Terbit 27-06-2019 | AMAROX PHARMA GLOBAL - INDONESIA | AMAROX PHARMA GLOBAL - INDONESIA | Obat Generik |
| 492 | Moxifloxacin HCl | Kaplet Salut Selaput | 400 mg | Moxibat | DKL1817627409A1 Tanggal Terbit 14-05-2019 | INTERBAT - INDONESIA | INTERBAT - INDONESIA | Obat Generik |
| 493 | Moxifloxacin HCl | Kaplet Salut Selaput | 400 mg | Garena | DKL1731539509A1 Tanggal Terbit 23-09-2019 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 494 | Moxifloxacin HCl | Kaplet Salut Selaput | 400 mg | Moxivid | DKL1702355109A1 Tanggal Terbit 28-08-2018 | BERNOFARM - INDONESIA | BERNOFARM - INDONESIA | Obat Generik |
| 495 | Moxifloxacin HCl | Kaplet Salut Selaput | 400 mg | Moxifloxacin HCl | GKL1605054709A1 Tanggal Terbit 02-08-2018 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 496 | Moxifloxacin HCl | Kaplet Salut Selaput | 400 mg | Moxifloxacin Hydrochloride | GKL2219935209A1 Tanggal Terbit 04-10-2022 | PHAPROS Tbk - Indonesia | PHAPROS Tbk - Indonesia | Obat Generik |
| 497 | Moxifloxacin HCl | Kaplet Salut Selaput | 400 mg | Maxiflon | DKL1308020509A1 Tanggal Terbit 17-10-2018 | GUARDIAN PHARMATAMA - INDONESIA | GUARDIAN PHARMATAMA - INDONESIA | Obat Generik |
| 498 | Moxifloxacin HCl | Tablet salut selaput | 400 mg | Moximed | DKL1439202817A1 Tanggal Terbit 3-05-2017 | FUTAMED PHARMACEUTICAL - INDONESIA | FUTAMED PHARMACEUTICAL - INDONESIA | Obat Generik |
| 499 | Moxifloxacin HCl | Kaplet salut selaput | 400 mg | Moxifloxacin HCl | GKL2244405717A1 Tanggal Terbit 24-07-2022 | KIMIA FARMA Tbk. - Indonesia | KIMIA FARMA Tbk. - Indonesia | Obat Generik |
| 500 | Moxifloxacin HCl | Kaplet Salut Selaput | 448 mg | Floxaris | DKL2018833509A1 Tanggal Terbit 28-07-2021 | OTTO PHARMACEUTICALS INDUSTRIES - INDONESIA | OTTO PHARMACEUTICAL INDUSTRIES - INDONESIA | Obat Generik |
