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 |
|---|---|---|---|---|---|---|---|---|
| 291 | Quetiapine Fumarate | Tablet Lepas Lambat | 150 mg | Seroquel XR | DKI1735300614E1 Tanggal Terbit 01-08-2018 | ASTRAZENECA PHARMACEUTICAL LP - USA | ASTRAZENECA - INDONESIA | Obat Komparator |
| 292 | Quetiapine Fumarate | Tablet Lepas Lambat | 200 mg | Seroquel XR | DKI1333500614B1 Tanggal Terbit 01-08-2018 | ASTRAZENECA PHARMACEUTICAL COMPANY LTD. | ASTRAZENECA - INDONESIA | Obat Komparator |
| 293 | Quetiapine Fumarate | Tablet Lepas Lambat | 300 mg | Seroquel XR | DKI1333500614C1 Tanggal Terbit 01-08-2018 | ASTRAZENECA PHARMACEUTICAL COMPANY LTD. | ASTRAZENECA - INDONESIA | Obat Komparator |
| 294 | Quetiapine Fumarate | Tablet Lepas Lambat | 400 mg | Seroquel XR | DKI1333500614D1 Tanggal Terbit 01-08-2018 | ASTRAZENECA PHARMACEUTICAL COMPANY LTD. | ASTRAZENECA - INDONESIA | Obat Komparator |
| 295 | Rabeprazole | Tablet Salut Enterik | 20 mg | Pariet | DKL1806102815B1 Tanggal Terbit 01-08-2018 | EISAI INDONESIA - INDONESIA | EISAI INDONESIA - INDONESIA | Obat Komparator |
| 296 | Rabeprazole | Tablet Salut Enterik | 10 mg | Pariet | DKL1806102815A1 Tanggal Terbit 01-08-2018 | EISAI INDONESIA - INDONESIA | EISAI INDONESIA - INDONESIA | Obat Komparator |
| 297 | Ramipril | Tablet | 5 mg | Triatec | DKL0121204010C1 Tanggal Terbit 23-03-2018 | AVENTIS PHARMA - INDONESIA | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 298 | Ramipril | Tablet | 10 mg | Triatec | DKL0521204010D1 Tanggal Terbit 26-01-2021 | AVENTIS PHARMA - INDONESIA | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 299 | Ramosetron HCl | Tablet | 0,1 mg | Nasea OD | DKI1237800110A1 Tanggal Terbit 12-10-2019 Masa Berlaku s/d 21-12-2022 | SEIKO EIYO YAKUHIN CO., LTD - JAPAN | COMBIPHAR - INDONESIA | Obat Komparator |
| 300 | Rebamipide | Tablet Salut Selaput | 100 mg | Mucosta | DKL0518707017A1 Tanggal Terbit 22-04-2021 | OTSUKA INDONESIA - INDONESIA | OTSUKA INDONESIA - 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 |
|---|---|---|---|---|---|---|---|---|
| 71 | Metoprolol | Tablet | (Metoprolol tartrate) 50 mg; 100 mg | Betaloc | Malaysia, Australia | Aztrazeneca Pharmaceutical Co. Ltd, China (MY) | Astrazeneca | - |
| 72 | Metoprolol | Tablet pelepasan lambat | (Metoprolol succinate) 95 mg | Betazok | Philippines | Astrazeneca AB, Sweden | Aztrazeneca Pharmaceuticals (Phils.) Inc | - |
| 73 | Metronidazole | Kapsul | 250 mg; 375 mg; 500 mg | Flagyl | USA | - | Pfizer Inc | - |
| 74 | Metronidazole | Tablet | 400 mg | Flagyl | Australia | - | Sanovi Aventis | - |
| 75 | Minocycline | Tablet lepas lambat | EQ 115 mg base | Solodyn | USA | - | BAUSCH HEALTH US LLC | - |
| 76 | Minocycline | Kapsul | 50 mg; 100 mg | Minocin | USA | - | BAUSCH HEALTH US LLC | - |
| 77 | Mirtazapine | Tablet | 30 mg; 15 mg | Remeron Sol Tab | Malaysia | - | Merck Sharp & Dohme Pharma - Malaysia | - |
| 78 | Molnupiravir | Kapsul | 200 mg | Lagevrio | Malaysia; UK | Patheon Inc, Canada (MY); Merck Sharp & Dohme BV, Netherland (UK) | Merck Sharp & Dohme (Malaysia) Sdn Bhd (MY); Merck Sharp & Dohme (UK) Limited (UK) | - |
| 79 | Nateglinide | Tablet salut selaput | 120 mg | Starlix | Germany | Germany | Novartis Europharm Limited | - |
| 80 | Nevirapine | Tablet | 200 mg | Viramune | USA | - | Boehringer Ingelheim | - |
LIST OF GENERIC DRUGS THAT HAVE MEET THE BIOECIVALENCE CRITERIA IN 2022
| No | ZAT AKTIF | BENTUK SEDIAAN | KEKUATAN | NAMA DAGANG | NIE | PRODUSEN | PENDAFTAR | STATUS |
|---|---|---|---|---|---|---|---|---|
| 51 | Aripiprazole | Tablet | 15 mg | Avram | DKL1721646610C1 Tanggal Terbit 18-12-2017 | PHAROS INDONESIA - INDONESIA | PHAROS INDONESIA - INDONESIA | Obat Generik |
| 52 | Atenolol | Tablet | 50 mg | Farnormin 50 | DKL8931502110B1 Tanggal Terbit 20-05-2019 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 53 | Atenolol | Tablet | 50 mg | Internolol | DKL9017606410B1 Tanggal Terbit 23-12-2020 | INTERBAT - INDONESIA | INTERBAT - INDONESIA | Obat Generik |
| 54 | Atorvastatin Calcium Trihydrate | Kaplet Salut Selaput | 20 mg | Fastor | DKL1413318809B1 Tanggal Terbit 22-02-2019 | LAPI - INDONESIA | LAPI - INDONESIA | Obat Generik |
| 55 | Atorvastatin Calcium Trihydrate | Kaplet Salut Selaput | 20 mg | Livator 20 | DKL2021028309A1 Tanggal Terbit 16-09-2022 | PYRIDAM FARMA TBK - Indonesia | PYRIDAM FARMA TBK - INDONESIA | Obat Generik |
| 56 | Atorvastatin Calcium Trihydrate | Tablet Salut Selaput | 40 mg | Atofit | DKL2043501417C1 Tanggal Terbit 07-08-2020 | AMAROX PHARMA GLOBAL - INDONESIA | AMAROX PHARMA GLOBAL - INDONESIA | Obat Generik |
| 57 | Atorvastatin Calcium Trihydrate | Tablet Salut Selaput | 40 mg | Orvast 40 | DKL1604526017C1 Tanggal Terbit 23-06-2022 | DARYA VARIA LABORATORIA - INDONESIA | DARYA VARIA LABORATORIA - INDONESIA | Obat Generik |
| 58 | Atorvastatin Calcium Trihydrate | Tablet Salut Selaput | 40 mg | Atofar 40 | DKL1031529817C1 Tanggal Terbit 21-11-2018 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 59 | Atorvastatin Calcium Trihydrate | Kaplet Salut Selaput | 40 mg | Atopid | DKL1702353309A1 Tanggal Terbit 04-05-2018 | BERNOFARM - INDONESIA | BERNOFARM - INDONESIA | Obat Generik |
| 60 | Atorvastatin Calcium Trihydrate | Tablet Salut Selaput | 10.9 mg | Truvaz | DKL1411643317A1 Tanggal Terbit 25-12-2019 | KALBE FARMA - INDONESIA | KALBE FARMA - INDONESIA | Obat Generik |
