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 |
|---|---|---|---|---|---|---|---|---|
| 351 | Thiamazole | Tablet Salut Selaput | 10 mg | Thyrozol | DKI0063401417B2 Tanggal Terbit 19-04-2022 | MERCK HEALTHCARE KGAA - FEDERAL REPUBLIC OF GERMANY | MERCK TBK - INDONESIA | Obat Komparator |
| 352 | Ticagrelor | Tablet Salut Selaput | 90 mg | Brilinta | DKI1635301117A1 Tanggal Terbit 23-03-2021 | ASTRAZENECA PHARMACEUTICAL COMPANY LTD. | ASTRAZENECA - INDONESIA | Obat Komparator |
| 353 | Ticagrelor | Tablet Salut Selaput | 60 mg | Brilinta | DKI1751303217A1 Tanggal terbit 21-01-2018 | ASTRAZENECA PHARMACEUTICALS - SWEDEN | ASTRAZENECA - INDONESIA | Obat Komparator |
| 354 | Tizanidine | Tablet | 2,28 mg | Sirdalud | DKL9330406410A1 Tanggal terbit 28 April 2021 | NOVARTIS INDONESIA - INDONESIA | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 355 | Topiramate | Tablet | 100 mg | Topamax | DKI1060000710C1 Tanggal Terbit 31-03-2020 | CILAG CHEMIE - SWITZERLAND | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Komparator |
| 356 | Topiramate | Tablet | 50 mg | Topamax | DKI1060000710B1 Tanggal Terbit 31-03-2020 | CILAG CHEMIE - SWITZERLAND | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Komparator |
| 357 | Topiramate | Tablet | 25 mg | Topamax | DKI1060000710A1 Tanggal Terbit 31-03-2020 | CILAG CHEMIE - SWITZERLAND | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Komparator |
| 358 | Topiramate | Kapsul | 25 mg | Topamax | DKI1210900501B1 Tanggal Terbit 09-04-2022 | JANSSEN ORTHO, LLC. - Puerto Rico | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Komparator |
| 359 | Topiramate | Kapsul | 15 mg | Topamax | DKI1210900501A1 Tanggal Terbit 09-04-2022 | JANSSEN ORTHO, LLC. - Puerto Rico | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Komparator |
| 360 | Trimetazidine | Tablet Salut Selaput Lepas Lambat | 35 mg | Trizedon MR | DKL1604524514A1 Tanggal terbit 17 Desember 2020 | DARYA VARIA LABORATORIA, INDONESIA LISENSI DARI 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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
