Shilpa Medicare gets 2 observations from AGES, Austria for Unit 4 of Jadcherla facility
Karnataka: Shilpa Medicare has received two minor observations from AGES, Austria at the conclusion of a Europe GMP inspection at the Company's Unit 4 of Jadcherla facility.
"Shilpa Medicare Limited, Unit 4, Jadcherla, Telangana, India had Europe GMP inspection by AGES, Austria from 22 January, 2024 until 26 January, 2024," the Company informed in a BSE filing.
This inspection has concluded with two minor observations.
The previous EU–GMP inspection for this facility was in January 2020.
This Unit of Shilpa Medicare is engaged in the manufacture, testing and distribution of sterile Injections and non-sterile tablets and Capsule finished dosage forms in the US, Europe and rest of the world markets.
"The Company intends to respond to the two minor observations within the stipulated time and is committed for the satisfactory resolution of the inspectional observations and sustained cGMP compliance," Shilpa Medicare stated.
Read also: Shilpa Medicare gets Germany marketing authorization for Amifampridine Tablets
Shilpa Medicare Limited started its operations as an API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of API and Formulation globally in different regulated markets.
