2026
|
No. |
Applicant |
Non-clinical study (number, title) |
Type of medicinal product |
Registration procedure |
Type of inspection |
Inspection status |
Pharmaceutical inspection results |
|
1 |
NPO Petrovax Pharm LLC |
SHR1258: 39-Week Oral (Gavage) Repeated Dose Toxicity Study with 4-Week of Recovery in Beagle Dogs |
Originator medicinal product |
Mutual recognition procedure |
Unscheduled, pre-authorisation |
In progress |
|
|
2 |
Izvarino Pharma LLC |
“Report on an experimental comparative non-clinical study of the acute toxicity, subchronic toxicity, and local irritant effect of Tirzepatide, solution for subcutaneous injection, 15 mg/dose (Tirzepatide, solution 25 mg/mL) (Izvarino Pharma LLC, Russia) and the reference medicinal product Mounjaro (INN: tirzepatide), solution for subcutaneous injection, 15 mg/dose (Eli Lilly Italia S.p.A., Italy)” |
Generic medicinal product |
Mutual recognition procedure |
Unscheduled, pre-authorisation |
In progress |
|
|
3 |
Pharmapark LLC |
S21009RD1: A 4-Week Repeated Dose Toxicity Study of BAT2206-IV Injection via Intravenous Injection in Cynomolgus Monkeys Followed by a 5-week Recovery Period |
Biosimilar medicinal product |
Mutual recognition procedure |
Unscheduled, pre-authorisation |
In progress |
|
|
4 |
Mylan Pharma LLC |
“A study of the acute and subchronic toxicity, including assessment of the local irritant effect, of Linagliptin, film-coated tablets, 5 mg (Mylan Laboratories Limited, H-12 & 13, MIDC Waluj, Aurangabad 431136, Maharashtra, India) compared with the reference product Trajenta® (INN: linagliptin), film-coated tablets, 5 mg (Boehringer Ingelheim International GmbH, Germany)” |
Generic medicinal product |
Mutual recognition procedure |
Unscheduled, pre-authorisation |
In progress |
|