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 |
|---|---|---|---|---|---|---|---|---|
| 211 | Levofloxacin Hemihydrate | Tablet Salut Selaput | 500 mg | Cravit | DKL9711628317B1 Tanggal Terbit 23-12-2020 | KALBE FARMA TBK, BEKASI, INDONESIA DIBAWAH LISENSI DAIICHI SANKYO CO., LTD., JEPANG | KALBE FARMA - INDONESIA | Obat Komparator |
| 212 | Levofloxacin Hemihydrate | Tablet Salut Selaput | 250 mg | Cravit | DKL9711628317A1 Tanggal Terbit 23-12-2020 | KALBE FARMA - INDONESIA, UNDER LICENSE OF DAIICHI SANKYO CO., LTD., JAPAN | KALBE FARMA - INDONESIA | Obat Komparator |
| 213 | Levofloxacin Hemihydrate | Kaplet Salut Selaput | 750 mg | Cravit | DKL1711645109A1 Tanggal Terbit 05-04-2022 | KALBE FARMA - INDONESIA | KALBE FARMA - INDONESIA | Obat Komparator |
| 214 | Levonorgestrel | Tablet | 0,75 mg | Postinor-2 | DKI0361300110A1 Tanggal Terbit 24-05-2020 | GEDEON RICHTER | TUNGGAL IDAMAN ABDI - INDONESIA | Obat Komparator |
| 215 | Levonorgestrel/ Ethinylestradiol | Tablet Salut Gula | 0,15 mg/ 0,03 mg | Microgynon | DKI1825800416A1 Tanggal Terbit 25-02-2022 | SCHERING DO BRASIL QUIMICA E FARMACEUTICA LTDA, BRAZIL | BAYER INDONESIA - INDONESIA | Obat Komparator |
| 216 | Levothyroxine Sodium | Tablet | 100 mcg | Euthyrox | DKI2163401910B1 Tanggal Terbit 16-02-2021 | MERCK HEALTHCARE KGAA - FEDERAL REPUBLIC OF GERMANY | MERCK TBK - INDONESIA | Obat Komparator |
| 217 | Levothyroxine Sodium | Tablet | 50 mcg | Euthyrox | DKI2163401910A1 Tanggal Terbit 16-02-2021 | MERCK HEALTHCARE KGAA - FEDERAL REPUBLIC OF GERMANY | MERCK TBK - INDONESIA | Obat Komparator |
| 218 | Linagliptin | Tablet Salut Selaput | 5 mg | Trajenta | DKI1152502817A1 Tanggal terbit 15-09-2021 | WEST WARD COLUMBUS INC., COLUMBUS - USA | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 219 | Linezolid | Tablet salut selaput | 600 mg | Zyvox | DKI2090701917A1 Tanggal Terbit 27-07-2020 | PFIZER PHARMACEUTICALS LLC - UNITED STATES OF AMERICA | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 220 | Lopinavir/Ritonavir | Tablet Salut Selaput | 200 mg/ 50 mg | Aluvia | DKI2182101017A1 Tanggal Terbit 06-12-2021 | ABBVIE DEUTSCHLAND GmbH & Co. K - JERMAN | PYRIDAM FARMA - 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 |
|---|---|---|---|---|---|---|---|---|
| 1 | - | - | - | - | - | - | - | - |
| 2 | Abiraterone Acetate | Tablet | 250 mg | Abirone | DKI2118603810A1 Tanggal terbit 23-03-2021 | HETERO LABS LIMITED - INDIA | AMAROX PHARMA GLOBAL - INDONESIA | Obat Generik |
| 3 | Abiraterone Acetate | Tablet | 250 mg | Abiranat | DKI2149500810A1 Tanggal Terbit 16-02-2021 | NATCO PHARMA LIMITED - INDIA | IMEDCO DJAJA - INDONESIA | Obat Generik |
| 4 | Abiraterone Acetate | Tablet | 250 mg | Birato 250 | DKI2156300210A1 Tanggal Terbit 06-12-2021 | MSN LABORATORIES PRIVATE LIMITED - INDIA | PYRIDAM FARMA TBK - INDONESIA | Obat Generik |
| 5 | Abiraterone Acetate | Tablet Salut Selaput | 250 mg | Cytabisan | DKI2199800717A1 Tanggal Terbit 03-01-2022 | DR. REDDY'S LABORATORIES LTD. | SANBE FARMA - INDONESIA | Obat Generik |
| 6 | Abiraterone Acetate | Tablet | 250 mg | Synterone 250 | DKI2243401310A1 Tanggal Terbit 07-04-2022 | SYNTHON HISPANIA, S.L. - Spain | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 7 | Abiraterone Acetate | Tablet Salut Selaput | 500 mg | Synterone 500 | DKI2243401517A1 Tanggal Terbit 24-09-2022 | SYNTHON HISPANIA, S.L. - Spain | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 8 | Acetylsalicylic Acid | Tablet Salut Enterik | 100 mg | Farmasal | DKL9231502715A1 Tanggal Terbit 14-11-2021 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 9 | Acetylsalicylic Acid | Tablet Salut Enterik | 100 mg | Astika | DKL9609311615A1 Tanggal Terbit 20-12-2021 | IKAPHARMINDO PUTRAMAS - Indonesia | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 10 | Aciclovir | Tablet | 200 mg | Aciclovir | GKL9832703710A1 Tanggal Terbit 02-01-2020 | YARINDO FARMATAMA - INDONESIA | YARINDO FARMATAMA - INDONESIA | Obat Generik |
