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 |
|---|---|---|---|---|---|---|---|---|
| 311 | Rosuvastatin Calcium | Tablet salut selaput | 10 mg | Crestor | DKI1435300817B1 Tanggal Terbit 19-10-2018 | IPR PHARMACEUTICAL INC-UNITED KINGDOM | ASTRAZENECA - INDONESIA | Obat Komparator |
| 312 | Rosuvastatin Calcium | Tablet salut selaput | 5 mg | Crestor | DKI1435300817A1 Tanggal Terbit 19-10-2018 | ASTRAZENECA UK LIMITED | ASTRAZENECA - INDONESIA | Obat Komparator |
| 313 | Salbutamol | Tablet | 2 mg | Ventolin | DKL9232000610A1 Tanggal Terbit 10-04-2018 | GLAXO WELLCOME INDONESIA - INDONESIA | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 314 | Salbutamol | Aerosol | 100 mcg/dosis | Ventolin Inhaler cfc free | DKI0382001939A1 Tanggal Terbit 29-10-2018 | GLAXO WELLCOME SA - SPAIN | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 315 | Salmeterol Xinafoate/ Fluticasone Propionat | Serbuk inhaler | 72,5 mg/ 100 mg | Seretide Diskus | DKI1991500167A1 Tanggal Terbit 21-01-2022 | Glaxo Wellcome Production - Evreux - France | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 316 | Salmeterol Xinafoate/ Fluticasone Propionat | Serbuk inhaler | 72,5 mg/ 250 mg | Seretide Diskus | DKI1991500167B1 Tanggal Terbit 21-01-2022 | Glaxo Wellcome Production - Evreux - France | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 317 | Salmeterol Xinafoate/ Fluticasone Propionat | Serbuk inhaler | 72,5 mg/ 500 mg | Seretide Diskus | DKI1991500167C1 Tanggal Terbit 21-01-2022 | Glaxo Wellcome Production - Evreux - France | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 318 | Saxagliptin | Tablet Salut Selaput | 5 mg | Onglyza | DKI1735301217A1 Tanggal Terbit 29-04-2019 | ASTRAZENECA PHARMACEUTICALS LP, MOUNT VERNON, AS | ASTRAZENECA - INDONESIA | Obat Komparator |
| 319 | Saxagliptin | Tablet Salut Selaput | 2,5 mg | Onglyza | DKI1835301517A1 Tanggal Terbit 19-11-2019 | BRISTOL MYERS SQUIBB SPA - ITALY | ASTRAZENECA - INDONESIA | Obat Komparator |
| 320 | Sildenafil Citrate | Tablet Salut Selaput | 25 mg | Viagra | DKI1990401417C1 Tanggal Terbit 29-03-2019 | FAREVA AMBOISE, AMBOISE - PERANCIS | 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 |
|---|---|---|---|---|---|---|---|---|
| 511 | Ofloxacin | Tablet salut selaput | 400 mg | Ofloxacin | GKL9720921417B1 Tanggal Terbit 30-05-2018 | INDOFARMA - INDONESIA | INDOFARMA - INDONESIA | Obat Generik |
| 512 | Ofloxacin | Tablet Salut Selaput | 200 mg | Flotavid 200 | DKL0033302617A1 Tanggal Terbit 25-10-2021 | MERSIFARMA TIRMAKU MERCUSANA - Indonesia | MERSIFARMA TIRMAKU MERCUSANA - Indonesia | Obat Generik |
| 513 | Ofloxacin | Kaplet Salut Selaput | 400 mg | Rilox | DKL9621010809B1 Tanggal Terbit 18-06-2020 | PYRIDAM FARMA TBK - Indonesia | PYRIDAM FARMA TBK - INDONESIA | Obat Generik |
| 514 | Ofloxacin | Kaplet Salut Selaput | 400 mg | Grafloxin | DKL0131107809A1 Tanggal Terbit 9-05-2018 | GRAHA FARMA - INDONESIA | GRAHA FARMA - INDONESIA | Obat Generik |
| 515 | Ofloxacin | Tablet salut selaput | 400 mg | Ofloxacin | GKL0433510217B1 Tanggal Terbit 24-06-2019 | ETERCON PHARMA - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 516 | Olanzapine | Tablet salut selaput | 5 mg | Onzapin | DKL1705518217A1 Tanggal Terbit 15-02-2019 | ACTAVIS LTD. - MALTA | ACTAVIS - INDONESIA | Obat Generik |
| 517 | Olanzapine | Tablet Salut Selaput | 11 mg | Remital 10 | DKL1021639417A1 Tanggal Terbit 21-02-2022 | PHAROS INDONESIA - INDONESIA | PHAROS INDONESIA - Indonesia | Obat Generik |
| 518 | Olanzapine | Tablet salut selaput | 10 mg | Zypin | DKL2143501817B1 Tanggal Terbit 01-06-2021 | AMAROX PHARMA GLOBAL - INDONESIA | AMAROX PHARMA GLOBAL - INDONESIA | Obat Generik |
| 519 | Olanzapine | Tablet Salut Selaput | 10 mg | Olaz | DKL2132722017A1 Tanggal Terbit 11-09-2021 | YARINDO FARMATAMA - Indonesia | YARINDO FARMATAMA - INDONESIA | Obat Generik |
| 520 | Omeprazole | Kapsul | 20 mg | Pumpitor | DKL1022248644A1 Tanggal terbit 13-01-2021 | CAPRIFARMINDO LABORATORIES - INDONESIA | SANBE FARMA - INDONESIA | Obat Generik |
