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 |
|---|---|---|---|---|---|---|---|---|
| 131 | Estazolam | Tablet | 2 mg | Esilgan | DPL7825102910B1 Tanggal Terbit 17-12-2020 | TAKEDA INDONESIA - INDONESIA | TAKEDA INDONESIA - INDONESIA | Obat Komparator |
| 132 | Estradiol Valrate/ Norgestrel | Tablet Salut Gula | 2 mg | Cycloprogynova | DKI0715900316A1 Tanggal Terbit 28-03-2018 | BAYER PHARMA AG, LEVERKUSEN - GERMANY | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 133 | Etodolac | Kapsul | 200 mg | Lonene | DKL9931805401A1 Tanggal Terbit 29-11-2019 | SUNTHI SEPURI, INDONESIA LISENSI DARI PFIZER INDONESIA - INDONESIA | SUNTHI SEPURI - INDONESIA | Obat Komparator |
| 134 | Etodolac | Kapsul | 300 mg | Lonene | DKL9931805401B1 Tanggal Terbit 06-12-2019 | SUNTHI SEPURI, INDONESIA LISENSI DARI PFIZER INDONESIA - INDONESIA | SUNTHI SEPURI - INDONESIA | Obat Komparator |
| 135 | Etonogestrel | Subdermal Implant | 68 mg | Implanon NXT | DKI1364803659A1 Tanggal Terbit 05-08-2021 | N.V. ORGANON - NETHERLANDS | ORGANON PHARMA INDONESIA TBK - INDONESIA | Obat Komparator |
| 136 | Etoricoxib | Tablet Salut Selaput | 60 mg | Arcoxia | DKL1906609417A1 Tanggal Terbit 05-08-2021 | ROVI PHARMA INDUSTRIAL SERVICES - Spain | ORGANON PHARMA INDONESIA TBK - Indonesia | Obat Komparator |
| 137 | Etoricoxib | Tablet Salut Selaput | 90 mg | Arcoxia | DKL1906609417B1 Tanggal Terbit 17-07-2021 | ROVI PHARMA INDUSTRIAL SERVICES - Spain | ORGANON PHARMA INDONESIA TBK - Indonesia | Obat Komparator |
| 138 | Etoricoxib | Tablet Salut Selaput | 120 mg | Arcoxia | DKL1906609417C1 Tanggal Terbit 17-07-2021 | ROVI PHARMA INDUSTRIAL SERVICES - Spain | ORGANON PHARMA INDONESIA TBK - Indonesia | Obat Komparator |
| 139 | Everolimus | Tablet | 10 mg | Afinitor | DKI1067507810B1 Tanggal Terbit 17-02-2020 | NOVARTIS PHARMA STEIN AG - SWITZERLAND | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 140 | Exemestane | Tablet salut gula | 25 mg | Aromasin | DKI0254200316A1 Tanggal Terbit 26-05-2021 | PFIZER ITALIA S.R.L - ITALY | PFIZER 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 |
|---|---|---|---|---|---|---|---|---|
| 541 | Pitavastatin Calcium | Tablet salut selaput | 2 mg | Vitor | DKL1805060117A1 Tanggal Terbit 28-02-2019 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 542 | Pramipexole | Tablet pelepasan Lambat | 0,375 mg | Pramifrol ER | DKI2054800714A1 Tanggal Terbit 22-06-2020 | MACLEODS PHARMACEUTICALS LIMITED - INDIA | SOHO INDUSTRI PHARMASI - INDONESIA | Obat Generik |
| 543 | Pravastatin Sodium | Tablet | 20 mg | Pravastatin Sodium | GKL2105065210B1 Tanggal Terbit 18-05-2022 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 544 | Pravastatin Sodium | Tablet | 20 mg | Pravastatin Sodium | GKL2105065210B1 Tanggal Terbit 18-05-2022 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 545 | Pregabalin | Kapsul | 75 mg | Prelin 75 | DKL1613712201A1 Tanggal Terbit 17-07-2021 | MAHAKAM BETA FARMA - INDONESIA | MAHAKAM BETA FARMA - INDONESIA | Obat Generik |
| 546 | Pregabalin | Kapsul | 75 mg | Nomathic | DKL1704526201A1 Tanggal terbit 02-02-2018 | DARYA VARIA LABORATORIA - INDONESIA | DARYA VARIA LABORATORIA - INDONESIA | Obat Generik |
| 547 | Pregabalin | Kapsul | 150 mg | Pregabalin 150 | GKL1405049701B1 Tanggal Terbit 25-12-2019 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 548 | Pregabalin | Kapsul | 150 mg | Pregabalin | GKL1533533601B1 Tanggal Terbit 12-10-2016 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 549 | Pregabalin | Kapsul | 300 mg | Aprion | DKL1021634301C1 Tanggal Terbit 22-01-2018 | PHAROS INDONESIA - INDONESIA | PHAROS INDONESIA - INDONESIA | Obat Generik |
| 550 | Pregabalin | Kapsul | 150 mg | Gabatrop | DKL1926013101B1 Tanggal Terbit 22-07-2019 | TROPICA MAS - INDONESIA | TROPICA MAS - INDONESIA | Obat Generik |
