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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|---|
| 481 | Methotrexate | Tablet | 2,5 mg | Ferxate | DKI1816201410A1 Tanggal Terbit 06-05-2019 | KOREA UNITED PHARM, INC- KOREA | FERRON PAR PHARMACEUTICALS - INDONESIA | Obat Generik |
| 482 | Methylphenidate | Tablet | 10 mg | Methylphenidate HCl | GPL1733314310A1 Tanggal Terbit 22-06-2017 | MERSIFARMA TIRMAKU MERCUSANA - INDONESIA | MERSIFARMA TIRMAKU MERCUSANA - INDONESIA | Obat Generik |
| 483 | Metoprolol Tartrate | Tablet | 100 mg | Loprolol | DKL0609318710A1 Tanggal Terbit 27-01-2021 | IKAPHARMINDO PUTRAMAS - INDONESIA | IKAPHARMINDO PUTRAMAS - INDONESIA | Obat Generik |
| 484 | Mometasone furoate | Nasal spray suspension | 0.0005 | Modexa | DKI1849700156A1 Tanggal Terbit 24-04-2019 | GLENMARK PHARMACEUTICALS LTD - INDIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 485 | Montelukast Sodium | Oral granule | 4 mg | Rymont | DKL1833541522A1 Tanggal Terbit 31-07-2019 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 486 | Montelukast Sodium | Tablet Salut Selaput | 10,4 mg | Aspira | DKI2055600117A1 Tanggal Terbit 29-05-2020 | PHARMANIAGA MANUFACTURING BERHAD - MALAYSIA | ERRITA PHARMA - INDONESIA | Obat Generik |
| 487 | Montelukast Sodium | Tablet Salut Selaput | 11,18 mg | Montelukast Sodium | GKL1931543917A1 Tanggal Terbit 26-05-2020 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 488 | Moxifloxacin HCl | Kaplet Salut Selaput | 400 mg | Cyfloxan | DKL2113028809A1 Tanggal Terbit 12-05-2022 | KONIMEX - INDONESIA | KONIMEX - INDONESIA | Obat Generik |
| 489 | Moxifloxacin HCl | Kaplet Salut Selaput | 400 mg | Respira | DKL1333529809A1 Tanggal Terbit 09-05-2018 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 490 | Moxifloxacin HCl | Tablet salut selaput | 400 mg | Zigat | DKL1221642717A1 Tanggal Terbit 11-06-2019 | PHAROS INDONESIA - INDONESIA | PHAROS INDONESIA - INDONESIA | Obat Generik |
