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 |
|---|---|---|---|---|---|---|---|---|
| 331 | Tadalafil | Tablet Salut Selaput | 20 mg | Cialis | DKI1973401817D1 Tanggal Terbit 16-02-2021 | LILLY DEL CARIBE INC - USA | PYRIDAM FARMA - INDONESIA | Obat Komparator |
| 332 | Tadalafil | Tablet Salut Selaput | 10 mg | Cialis | DKI1973401817C1 Tanggal Terbit 16-02-2021 | LILLY DEL CARIBE INC - USA | PYRIDAM FARMA - INDONESIA | Obat Komparator |
| 333 | Tadalafil | Tablet Salut Selaput | 5 mg | Cialis | DKI1973401817B1 Tanggal Terbit 06-03-2020 | LILLY DEL CARIBE INC - USA | PYRIDAM FARMA - INDONESIA | Obat Komparator |
| 334 | Tadalafil | Tablet Salut Selaput | 2,5 mg | Cialis | DKI1973401817A1 Tanggal Terbit 15-03-2020 | LILLY DEL CARIBE INC - USA | PYRIDAM FARMA - INDONESIA | Obat Komparator |
| 335 | Tamsulosin | Tablet Lepas Lambat | 0,4 mg | Harnal OCAS | DKI1120100414A1 Tanggal Terbit 21-10-2021 | ASTELLAS PHARMA EUROPE B.V, BELANDA | COMBIPHAR - INDONESIA | Obat Komparator |
| 336 | Telmisartan | Tablet | 80 mg | Micardis | DKI2055200210B1 Tanggal Terbit 02-05-2020 | BOEHRINGER INGELHEIM ELLAS A.E - GREECE | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 337 | Telmisartan | Tablet | 40 mg | Micardis | DKI2055200210A1 Tanggal Terbit 02-05-2020 | BOEHRINGER INGELHEIM ELLAS A.E - GREECE | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 338 | Telmisartan/ Amlodipin | Tablet | 40/ 5 mg | Twynsta | DKI2124200210A1 Tanggal Terbit 27-01-2021 | CIPLA LIMITED - INDIA | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 339 | Telmisartan/ Amlodipin | Tablet | 40/ 10 mg | Twynsta | DKI2124200210B1 Tanggal Terbit 27-01-2021 | CIPLA LIMITED - INDIA | BOEHRINGER INGELHEIM INDONESIA - INDONESIA | Obat Komparator |
| 340 | Telmisartan/ Amlodipin | Tablet | 80/ 5 mg | Twynsta | DKI2124200210C1 Tanggal Terbit 27-01-2021 | CIPLA LIMITED - INDIA | 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 |
|---|---|---|---|---|---|---|---|---|
| 491 | Moxifloxacin HCl | Tablet salut selaput | 400 mg | Moxifloxacin HCl | GKL1943500117A1 Tanggal Terbit 27-06-2019 | AMAROX PHARMA GLOBAL - INDONESIA | AMAROX PHARMA GLOBAL - INDONESIA | Obat Generik |
| 492 | Moxifloxacin HCl | Kaplet Salut Selaput | 400 mg | Moxibat | DKL1817627409A1 Tanggal Terbit 14-05-2019 | INTERBAT - INDONESIA | INTERBAT - INDONESIA | Obat Generik |
| 493 | Moxifloxacin HCl | Kaplet Salut Selaput | 400 mg | Garena | DKL1731539509A1 Tanggal Terbit 23-09-2019 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 494 | Moxifloxacin HCl | Kaplet Salut Selaput | 400 mg | Moxivid | DKL1702355109A1 Tanggal Terbit 28-08-2018 | BERNOFARM - INDONESIA | BERNOFARM - INDONESIA | Obat Generik |
| 495 | Moxifloxacin HCl | Kaplet Salut Selaput | 400 mg | Moxifloxacin HCl | GKL1605054709A1 Tanggal Terbit 02-08-2018 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 496 | Moxifloxacin HCl | Kaplet Salut Selaput | 400 mg | Moxifloxacin Hydrochloride | GKL2219935209A1 Tanggal Terbit 04-10-2022 | PHAPROS Tbk - Indonesia | PHAPROS Tbk - Indonesia | Obat Generik |
| 497 | Moxifloxacin HCl | Kaplet Salut Selaput | 400 mg | Maxiflon | DKL1308020509A1 Tanggal Terbit 17-10-2018 | GUARDIAN PHARMATAMA - INDONESIA | GUARDIAN PHARMATAMA - INDONESIA | Obat Generik |
| 498 | Moxifloxacin HCl | Tablet salut selaput | 400 mg | Moximed | DKL1439202817A1 Tanggal Terbit 3-05-2017 | FUTAMED PHARMACEUTICAL - INDONESIA | FUTAMED PHARMACEUTICAL - INDONESIA | Obat Generik |
| 499 | Moxifloxacin HCl | Kaplet salut selaput | 400 mg | Moxifloxacin HCl | GKL2244405717A1 Tanggal Terbit 24-07-2022 | KIMIA FARMA Tbk. - Indonesia | KIMIA FARMA Tbk. - Indonesia | Obat Generik |
| 500 | Moxifloxacin HCl | Kaplet Salut Selaput | 448 mg | Floxaris | DKL2018833509A1 Tanggal Terbit 28-07-2021 | OTTO PHARMACEUTICALS INDUSTRIES - INDONESIA | OTTO PHARMACEUTICAL INDUSTRIES - INDONESIA | Obat Generik |
