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 |
|---|---|---|---|---|---|---|---|---|
| 221 | Lopinavir/Ritonavir | Tablet Salut Selaput | 100 mg/ 25 mg | Aluvia | DKI1082100817B1 Tanggal Terbit 06-03-2020 | ABBVIE DEUTSCHLAND GmbH & Co. K - JERMAN | ABBOTT INDONESIA - INDONESIA | Obat Komparator |
| 222 | Loratadine | Tablet | 10 mg | Claritin | DTL2102009810A1 Tanggal Terbit 23-12-2021 | BAYER INDONESIA - INDONESIA | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 223 | Lorazepam | Tablet | 0,5 mg | Ativan | DPL8931800210A1 Tanggal Terbit 29-11-2019 | SUNTHI SEPURI, INDONESIA DENGAN LISENSI WYETH AYERST LABORATORIES - UNITED STATES OF AMERICA | SUNTHI SEPURI - INDONESIA | Obat Komparator |
| 224 | Lorazepam | Tablet | 1 mg | Ativan | DPL8931800210B1 Tanggal Terbit 29-11-2019 | SUNTHI SEPURI, INDONESIA DENGAN LISENSI WYETH AYERST LABORATORIES - UNITED STATES OF AMERICA | SUNTHI SEPURI - INDONESIA | Obat Komparator |
| 225 | Lorazepam | Tablet | 2 mg | Ativan | DPL8931800210C1 Tanggal Terbit 29-11-2019 | SUNTHI SEPURI, INDONESIA DENGAN LISENSI WYETH AYERST LABORATORIES - UNITED STATES OF AMERICA | SUNTHI SEPURI - INDONESIA | Obat Komparator |
| 226 | Losartan | Tablet Salut Selaput | 50 mg | Cozaar | DKL2006609617A1 Tanggal Terbit 23-12-2021 | ORGANON PHARMA (UK) LIMITED - United Kingdom | ORGANON PHARMA INDONESIA TBK - INDONESIA | Obat Komparator |
| 227 | Medroxyprogesterone acetate | Tablet | 10 mg | Provera | DKI0054200210C1 Tanggal Terbit 29-11-2020 | PFIZER ITALIA S.R.L - ITALY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 228 | Medroxyprogesterone acetate | Tablet | 100 mg | Provera | DKI0054200210D1 Tanggal Terbit 29-11-2020 | PFIZER ITALIA S.R.L - ITALY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 229 | Meloxicam | Tablet | 15 mg | Movi-Cox | DKL0133701110B1 Tanggal Terbit 21--01-2019 | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 230 | Meloxicam | Tablet | 7,5 mg | Movi-Cox | DKL0133701110A1 Tanggal Terbit 21-01- 2019 | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | BOEHRINGER INGELHEIM 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 |
|---|---|---|---|---|---|---|---|---|
| 61 | Atorvastatin Calcium Trihydrate | Tablet Salut Selaput | 40 mg | Atorvastatin Calcium | GKL1433532017B1 Tanggal Terbit 23-03-2021 | ETERCON PHARMA - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 62 | Atorvastatin Calcium Trihydrate | Tablet Salut Selaput | 10.9 mg | Truvaz | DKL1411643317A1 Tanggal Terbit 25-12-2019 | KALBE FARMA - INDONESIA | KALBE FARMA - INDONESIA | Obat Generik |
| 63 | Atorvastatin Calcium Trihydrate | Tablet Salut Selaput | 20 mg | Cholestor | DKL1634604317B1 Tanggal Terbit 11-10-2021 | DEXA MEDICA - INDONESIA | FERRON PAR PHARMACEUTICALS - INDONESIA | Obat Generik |
| 64 | Atorvastatin Calcium Trihydrate | Tablet Salut Selaput | 20 mg | Removchol | DKL1333530017A1 Tanggal Terbit 23-06-2022 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 65 | Atorvastatin Calcium Trihydrate | Kaplet Salut Selaput | 40 mg | Avesco 40 | DKL1302505209C1 Tanggal Terbit 02-08-2018 | DIPA PHARMALAB INTERSAINS - INDONESIA | DIPA PHARMALAB INTERSAINS - INDONESIA | Obat Generik |
| 66 | Atorvastatin Calcium Trihydrate/ Amlodipine Besilate | Tablet Salut Selaput | 20 mg/ 5 mg | Carduo | DKL2032720917A1 Tanggal Terbit 19-09-2020 | YARINDO FARMATAMA - INDONESIA | YARINDO FARMATAMA - INDONESIA | Obat Generik |
| 67 | Azithromycin Dihydrate | Kaplet Salut Selaput | 500 mg | Zithrax | DKL9604413909A1 Tanggal Terbit 31-12-2018 | DANKOS FARMA - INDONESIA | DANKOS FARMA - INDONESIA | Obat Generik |
| 68 | Azithromycin Dihydrate | Kaplet Salut Selaput | 500 mg | Zycin 500 | DKL0917624109A1 Tanggal Terbit 23-08-2020 | INTERBAT - INDONESIA | INTERBAT - INDONESIA | Obat Generik |
| 69 | Azithromycin Dihydrate | Kaplet Salut Selaput | 500 mg | Zarom 500 | DKL1621022509A1 Tanggal Terbit 14-08-2017 | PYRIDAM FARMA TBK - Indonesia | PYRIDAM FARMA TBK - INDONESIA | Obat Generik |
| 70 | Azithromycin Dihydrate | Sirup Kering | 200 mg/5 ml | Zibramax | DKL1008015438A1 Tanggal Terbit 11-03-2020 | GUARDIAN PHARMATAMA - INDONESIA | GUARDIAN PHARMATAMA - INDONESIA | Obat Generik |
