By: IPP Bureau
Last updated : December 22, 2024 6:13 pm
The company has received the GMP Certification after successful closure of the inspection
Shilpa Medicare Limited, Unit 7, Nacharam, Hyderabad, Telangana, India had completed an inspection from EMA, Europe from 24th to 26th September 2024.
The company has received the GMP Certification after successful closure of the inspection.
Shilpa Medicare Limited, Unit VII, has an Analytical Services Division (QC) and a Bio Analytical Department. Both laboratories are approved by USFDA. The Bio-Analytical Laboratory is already approved by EMA, Europe.
This inspection was the first Europe inspection for the QC laboratory of Unit VII. This Laboratory is involved in testing drug substances, raw materials, packing materials and finished products. It is also engaged in other analytical activities like analytical method validations, method transfers and other miscellaneous analytical studies. The laboratory has been testing samples for final release into US, EU and other markets.