1. List of active ingredients that need to have bioequivalent study in the registration dossier
No | Active substance |
1 | Amlodipine |
2 | Azithromycin |
3 | Carbamazepine |
4 | Cefixime |
5 | Cefuroxime axetil |
6 | Clarithromycin |
7 | Glibenclamide |
8 | Gliclazide |
9 | Metformin |
10 | Metoprolol |
11 | Nifedipine |
12 | Rifampicine |
13 | Amoxicillin + Clavulanic acid |
14 | Carvedilol |
15 | Cefpodoxime |
16 | Ezetimibe |
17 | Irbesartan |
18 | Itraconazole |
19 | Risperidone |
20 | Rosuvastatine |
21 | Simvastatine |
22 | Sulpiride |
23 | Sultamicilline |
24 | Telmisartan |
25 | Valproate sodium |
26 | Fenofibrate |
2. List of dosage forms that need to have bioequivalent study in registration dossier
– Generic drugs in the form of immediate release dosage, including active substance mentioned in table above.
– Generic drugs in the form of modified release dosage (gastro-resistant, prolonged release, multiphasic release, intramuscular/ subcutaneous depot, transdermal drug delivery system)