Shilpa Medicare Analytical Services Division gets 2 minor observations from USFDA

Written by Ruchika Sharma Published On 2023-03-11T14:00:43+05:30 | Updated On 11 March 2023 2:00 PM IST

Shilpa Pharma Lifesciences gets 1 UFSDA observation for Raichur Unit

Karnataka: Shilpa Medicare has announced that the US Food and Drug Administration (USFDA) has closed the inspection with two minor observations at the company's Analytical Services Division situated at Unit 7, Nacharam, Hyderabad, Telangana. This is a full GMP inspection.

The unit has been inspected by US FDA from 08 March 2023 to 10 March 2023.

"The Company will be submitting the responses to US FDA observations within stipulated timeline and will work towards implementing the corrective actions to address the observations," Shilpa medicare stated in a recent BSE filing.

"The inspection is closed with 2 minor observations, which are related to improvements in existing procedures and are addressable," the company added.

This is the second US FDA inspection on the site.

The initial inspection was done during April 2022, for which the GMP clearance (EIR) was issued in July 2022.

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 is involved in the testing of US/EU & other markets commercial batches.

Shilpa Medicare Limited started its operations as 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 affordable API and Formulation globally in different regulated markets.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751