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 |
|---|---|---|---|---|---|---|---|---|
| 231 | Diclofenac sodium | Tablet Salut enterik | 50 mg | Lafen | DKL1906318915A1 Tanggal Terbit 12-10-2019 | ERELA - INDONESIA | ERELA - INDONESIA | Obat Generik |
| 232 | Diclofenac sodium | Tablet salut enterik | 50 mg | Novaren 50 | DKL2234014615A1 Tanggal Terbit 22-07-2022 | NOVAPHARIN - INDONESIA | NOVAPHARIN - INDONESIA | Obat Generik |
| 233 | Diclofenac sodium | Kapsul salut enterik | 50 mg | Prostanac 50 | DKL9221005907B1 Tanggal Terbit 12-05-2022 | PYRIDAM FARMA TBK - Indonesia | PYRIDAM FARMA TBK - INDONESIA | Obat Generik |
| 234 | Diclofenac sodium | Tablet Salut enterik | 50 mg | Diclofenac Sodium | GKL0533514915A1 Tanggal Terbit 12-04-2019 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 235 | Diclofenac sodium | Tablet Salut enterik | 50 mg | Samcofenac 50 | DKL1321907515B1 Tanggal Terbit 10-07-2020 | SAMCO FARMA - INDONESIA | SAMCO FARMA - INDONESIA | Obat Generik |
| 236 | Diclofenac sodium | Tablet Salut enterik | 50 mg | Zegren 50 | DKL9313303215B1 Tanggal Terbit 01-07-2020 | LAPI LABORATORIES - INDONESIA | LAPI LABORATORIES - INDONESIA | Obat Generik |
| 237 | Diclofenac sodium | Tablet Pelepasan Lambat | 100 mg | Clofecon | DKL2115721514A1 Tanggal Terbit 17-03-2021 | NOVELL PHARMACEUTICAL LAB - INDONESIA | ETERCON PHARMA - INDONESIA | Obat Generik |
| 238 | Dienogest | Tablet | 2 mg | Nelandoz | DKL2031547710A1 Tanggal Terbit 29-12-2020 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 239 | Divalproex sodium | Tablet salut enterik | 250 mg | Velpraz | DKL1633536615A1 Tanggal Terbit 01-08-2018 | NOVELL PHARMACEUTICAL LAB - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 240 | Divalproex sodium | Kaplet salut enterik | 250 mg | Divalpi EC | DKL1511644507A1 Tanggal Terbit 06-08-2021 | KALBE FARMA - INDONESIA | KALBE FARMA - INDONESIA | Obat Generik |
