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 |
|---|---|---|---|---|---|---|---|---|
| 501 | Mycophenolate Mofetil | Tablet salut selaput | 500 mg | Mycocell | DKI1953400117A1 Tanggal Terbit 23-08-2019 | ALKEM LABORATORIES LIMITED-INDIA | PHAPROS - INDONESIA | Obat Generik |
| 502 | Mycophenolate Mofetil | Kaplet Salut Selaput | 500 mg | Kamyfet | DKL1811645409A1 Tanggal Terbit 30-01-2019 | KALBE FARMA - INDONESIA | KALBE FARMA - INDONESIA | Obat Generik |
| 503 | Mycophenolate Mofetil | Kaplet Salut Selaput | 500 mg | Celmunos | DKI2055900109A1 Tanggal Terbit 02-08-2020 | CONCORD BIOTECH LTD. - INDIA | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Generik |
| 504 | Mycophenolate Sodium | Tablet Salut Enterik | 384,70 mg | Mycophen 360 | DKI2055900215B1 Tanggal Terbit 19-09-2020 | CONCORD BIOTECH LTD. - INDIA | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Generik |
| 505 | Nebivolol Hydrochloride | Tablet | 5 mg | Nebivolol | GKL2033550010A1 Tanggal Terbit 04-10-2020 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 506 | Nebivolol Hydrochloride | Tablet | 5,450 mg | Linoven | DKL2033550110A1 Tanggal Terbit 04-10-2020 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 507 | Nifedipine | Tablet pelepasan Lambat | 10 mg | Farmalat ER | DKL8831500314A1 Tanggal Terbit 16-12-2019 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 508 | Nomegestrol Acetate | Tablet Salut Selaput | 5 mg | Prodefi | DKL2133553417A1 Tanggal Terbit 10-12-2021 | ETERCON PHARMA - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 509 | Ofloxacin | Tablet salut selaput | 400 mg | Akilen 400 | DKL9522213017B1 Tanggal Terbit 31-12-2018 | SANBE FARMA - INDONESIA | SANBE FARMA - INDONESIA | Obat Generik |
| 510 | Ofloxacin | Tablet salut selaput | 400 mg | Ofloxacin | GKL0005029617B1 Tanggal Terbit 08-04-2022 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
