Shilpa Medicare gets 4 USFDA observations for Hyderabad division

Hyderabad: After a recent inspection, the U.S. Food and Drug Administration (USFDA) has issued four observations to Shilpa Medicare's recently started Analytical Services Division situated in Hyderabad.

The inspection was conducted from 26 April 2022 to 29 April 2022.

"This is to inform you that the Company's recently started Analytical Services Division situated on first Floor of Unit 7, Nacharam, Hyderabad, Telangana was inspected by U.S. Food and Drug Administration (USFDA) during 26 Apr 2022 to 29 Apr 2022." the company said in a BSE filing.

The inspection came after Shilpa's submission of applications for four ANDA's to seek approval to use this site as alternate testing laboratory. The inspection has been closed with four observations, which are related to improvements in existing procedures and are addressable.

Read also: Shilpa Medicare clears USFDA review for Dabaspet facility

"The Company will be submitting the responses to USFDA observations within stipulated timeline and implement the corrective actions to address the observations," Shilpa Medicare further added.

This Analytical Services Division has started analytical testing operations from May 2021. This is the first USFDA inspection of this facility.

The facility is involved in analytical testing of drug products, drug substances, raw materials & packing materials. It is also engaged in analytical method validations, method transfers and conduct of other miscellaneous studies. This facility has not been used till now to test products for commercial dispatch into US/EU markets.

Read also: Shilpa Biologicals gets NoC to conduct trials of biosimilar Aflibercept

Shilpa Medicare Limited started its operations as API manufacturer way back in 1987 at Raichur, Karnataka, India. The commercial production in the Shilpa Medicare Ltd was started in November 1989. 

Read also: Shilpa Biologics, Mylab ink pact to enter vaccine, therapeutics segment