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 |
|---|---|---|---|---|---|---|---|---|
| 151 | Ciprofloxacin | Tablet Salut Selaput | 500 mg | Ciflos 500 | DKL9508003817B1 Tanggal Terbit 26-03-2019 | GUARDIAN PHARMATAMA - INDONESIA | GUARDIAN PHARMATAMA - INDONESIA | Obat Generik |
| 152 | Ciprofloxacin | Kaplet Salut Selaput | 500 mg | Cylowam 500 | DKL9513008209B1 Tanggal Terbit 21-03-2019 | KONIMEX - INDONESIA | KONIMEX - INDONESIA | Obat Generik |
| 153 | Ciprofloxacin | Kaplet Salut Selaput | 500 mg | Siflox 500 | DKL0433306609A1 Tanggal Terbit 15-10-2019 | MERSIFARMA TIRMAKU MERCUSANA - INDONESIA | MERSIFARMA TIRMAKU MERCUSANA - INDONESIA | Obat Generik |
| 154 | Ciprofloxacin | Kaplet Salut Selaput | 500 mg | Floksid | DKL0033201609A1 Tanggal Terbit 18-12-2017 | PROMEDRAHARDJO FARMASI INDUSTRI - INDONESIA | PROMEDRAHARDJO FARMASI INDUSTRI - INDONESIA | Obat Generik |
| 155 | Ciprofloxacin | Kaplet Salut Selaput | 500 mg | Novaflox 500 | DKL0634006009A1 Tanggal Terbit 24-09-2018 | NOVAPHARIN - INDONESIA | NOVAPHARIN - INDONESIA | Obat Generik |
| 156 | Ciprofloxacin | Kaplet Salut Selaput | 500 mg | Omeproksil | DKL9916906809A1 Tanggal Terbit 10-09-2019 | MUTIARA MUKTI FARMA - INDONESIA | MUTIARA MUKTI FARMA - INDONESIA | Obat Generik |
| 157 | Ciprofloxacin | Kaplet Salut Selaput | 500 mg | Viflox | DKL0226007409A1 Tanggal Terbit 09-02-2018 | TROPICA MAS - INDONESIA | TROPICA MAS - INDONESIA | Obat Generik |
| 158 | Ciprofloxacin | Kaplet Salut Selaput | 500 mg | Tequinol | DKL9318811309A1 Tanggal Terbit 30-04-2019 | OTTO PHARMACEUTICALS INDUSTRIES - INDONESIA | OTTO PHARMACEUTICAL INDUSTRIES - INDONESIA | Obat Generik |
| 159 | Ciprofloxacin | Kaplet Salut Selaput | 500 mg | Volinol | DKL9321006809A1 Tanggal Terbit 13-09-2019 | PYRIDAM FARMA TBK - Indonesia | PYRIDAM FARMA TBK - INDONESIA | Obat Generik |
| 160 | Ciprofloxacin | Kaplet Salut Selaput | 500 mg | Baquinor Forte | DKL9222212809A1 Tanggal Terbit 31-10-2019 | CAPRIFARMINDO LABORATORIES - INDONESIA | SANBE FARMA - INDONESIA | Obat Generik |
