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 |
|---|---|---|---|---|---|---|---|---|
| 51 | Bisoprolol Fumarate | Tablet Salut Selaput | 10 mg | Concor | DKL9115803817B1 Tanggal Terbit 18-06-2020 | MERCK INDONESIA TBK - INDONESIA LISENSI OLEH MERCK HEALTHCARE KGAA - FEDERAL REPUBLIC OF GERMANY | MERCK TBK - INDONESIA | Obat Komparator |
| 52 | Bisoprolol Fumarate | Tablet Salut Selaput | 1,25 mg | Concor | DKL1015803817C1 Tanggal Terbit 18-06-2020 | MERCK - INDONESIA DIBAWAH LISENSI MERCK KGAA - FEDERAL REPUBLIC OF GERMANY | MERCK TBK - INDONESIA | Obat Komparator |
| 53 | Bisoprolol Fumarate | Tablet Salut Selaput | 2,5 mg | Concor | DKL0215803817B1 Tanggal Terbit 07-06-2020 | MERCK - INDONESIA DIBAWAH LISENSI MERCK KGAA - FEDERAL REPUBLIC OF GERMANY | MERCK TBK - INDONESIA | Obat Komparator |
| 54 | Bisoprolol Fumarate/ Hydrochlorthiazide | Tablet Salut Selaput | 5 mg/ 6,25 mg | Lodoz 5 | DKL0415807317B1 Tanggal Terbit 14-06-2021 | MERCK INDONESIA TBK - INDONESIA LISENSI OLEH MERCK HEALTHCARE KGAA - FEDERAL REPUBLIC OF GERMANY | MERCK TBK - INDONESIA | Obat Komparator |
| 55 | Buprenorphine HCl/ Naloxone | Tablet Sublingual | 2 mg/ 0,5 mg | Suboxone | DNI1166700474A1 Tanggal Terbit 23-12-2021 | RECKITT BENCKISSER HEALTHCARE - UK | KIMIA FARMA, JAKARTA - INDONESIA | Obat Komparator |
| 56 | Buprenorphine HCl/ Naloxone | Tablet Sublingual | 8 mg/ 2 mg | Suboxone | DNI1166700474B1 Tanggal Terbit 23-12-2021 | RECKITT BENCKISSER HEALTHCARE - UK | KIMIA FARMA, JAKARTA - INDONESIA | Obat Komparator |
| 57 | Candesartan Cilexetil | Tablet | 16 mg | Blopress | DKL9825101910B1 Tanggal Terbit 29-06-2021 | TAKEDA INDONESIA - INDONESIA DENGAN LISENSI TAKEDA PHARMACEUTICAL COMPANY, JAPAN | TAKEDA INDONESIA - INDONESIA | Obat Komparator |
| 58 | Candesartan Cilexetil | Tablet | 8 mg | Blopress | DKL9825101910A1 Tanggal Terbit 29-06-2021 | TAKEDA INDONESIA - INDONESIA | TAKEDA INDONESIA - INDONESIA | Obat Komparator |
| 59 | Candesartan Cilexetil/ Hydrochlorthiazide | Tablet | 16 mg/ 12,5 mg | Blopress Plus 16 | DKL1825103610A1 Tanggal Terbit 06-11-2018 | TAKEDA INDONESIA - INDONESIA | TAKEDA INDONESIA - INDONESIA | Obat Komparator |
| 60 | Capecitabine | Tablet Salut Selaput | 500 mg | Xeloda | DKI1157507117A1 Tanggal Terbit 16-05-2021 | EXCELLA GMBH & CO. KG - Federal Republic of Germany | 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 |
|---|---|---|---|---|---|---|---|---|
| 21 | Desogestrel | Tablet salut selaput | 0,075 mg | Cerazette | Philippines | NV Organon Netherland | Organon / Merck Sharp & Dohme | - |
| 22 | Dexamethasone | Tablet | 1mg; 2mg; 4mg; 6mg | Dexamethasone | USA | - | Hikma Pharmaceuticals USA Inc | - |
| 23 | Diazepam | Tablet | 10 mg | Valium | Philippines, USA | - | Roche (Phil), Hoffmann La Roche (US) | - |
| 24 | Digoxin | Tablet | 250 mcg | Lanoxin | USA, Malaysia, Philippines | ` | CONCORDIA PHARMACEUTICALS INC; Aspen Medical Products (MY); Aspen (PH) | - |
| 25 | Dihydroartemisinin (kombinasi Piperaquine) | Tablet Salut Selaput | 20 mg/160 mg; 40/320 mg | Eurartesim | Germany, Netherland | - | Alfasigma SpA | - |
| 26 | Disopyramide | Kapsul | 150 mg | Norpace | USA | - | PFIZER INC | - |
| 27 | Disopyramide | Kapsul lepas lambat | 150 mg | Norpace CR | USA | - | PFIZER INC | - |
| 28 | Doxycycline | Suspensi | 25 mg/5ml | Vibramycin | USA | - | PFIZER LABORATORIES DIV PFIZER INC | - |
| 29 | Doxycycline (as Hydrochloride) | Kapsul | 100 mg | Vibramycin | Australia, Philippines | - | Pfizer | - |
| 30 | Drospirenone | Tablet | 4 mg | SLYND | USA | - | EXELTIS USA 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 |
|---|---|---|---|---|---|---|---|---|
| 51 | Aripiprazole | Tablet | 15 mg | Avram | DKL1721646610C1 Tanggal Terbit 18-12-2017 | PHAROS INDONESIA - INDONESIA | PHAROS INDONESIA - INDONESIA | Obat Generik |
| 52 | Atenolol | Tablet | 50 mg | Farnormin 50 | DKL8931502110B1 Tanggal Terbit 20-05-2019 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 53 | Atenolol | Tablet | 50 mg | Internolol | DKL9017606410B1 Tanggal Terbit 23-12-2020 | INTERBAT - INDONESIA | INTERBAT - INDONESIA | Obat Generik |
| 54 | Atorvastatin Calcium Trihydrate | Kaplet Salut Selaput | 20 mg | Fastor | DKL1413318809B1 Tanggal Terbit 22-02-2019 | LAPI - INDONESIA | LAPI - INDONESIA | Obat Generik |
| 55 | Atorvastatin Calcium Trihydrate | Kaplet Salut Selaput | 20 mg | Livator 20 | DKL2021028309A1 Tanggal Terbit 16-09-2022 | PYRIDAM FARMA TBK - Indonesia | PYRIDAM FARMA TBK - INDONESIA | Obat Generik |
| 56 | Atorvastatin Calcium Trihydrate | Tablet Salut Selaput | 40 mg | Atofit | DKL2043501417C1 Tanggal Terbit 07-08-2020 | AMAROX PHARMA GLOBAL - INDONESIA | AMAROX PHARMA GLOBAL - INDONESIA | Obat Generik |
| 57 | Atorvastatin Calcium Trihydrate | Tablet Salut Selaput | 40 mg | Orvast 40 | DKL1604526017C1 Tanggal Terbit 23-06-2022 | DARYA VARIA LABORATORIA - INDONESIA | DARYA VARIA LABORATORIA - INDONESIA | Obat Generik |
| 58 | Atorvastatin Calcium Trihydrate | Tablet Salut Selaput | 40 mg | Atofar 40 | DKL1031529817C1 Tanggal Terbit 21-11-2018 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
| 59 | Atorvastatin Calcium Trihydrate | Kaplet Salut Selaput | 40 mg | Atopid | DKL1702353309A1 Tanggal Terbit 04-05-2018 | BERNOFARM - INDONESIA | BERNOFARM - INDONESIA | Obat Generik |
| 60 | Atorvastatin Calcium Trihydrate | Tablet Salut Selaput | 10.9 mg | Truvaz | DKL1411643317A1 Tanggal Terbit 25-12-2019 | KALBE FARMA - INDONESIA | KALBE FARMA - INDONESIA | Obat Generik |
