Shilpa Medicare clears USFDA review for Dabaspet facility

Written by Ruchika Sharma Published On 2021-11-20T13:02:06+05:30 | Updated On 20 Nov 2021 1:12 PM IST

Shilpa Medicare clears USFDA review for Dabaspet facility

Hyderabad: Shilpa Medicare Limited has recently announced that United States Food and Drug Administration (USFDA) has concluded Remote Record Review of the company, Unit III, Research and Development facility situated at Dabaspet, Bengaluru, Karnataka without any objectionable conditions or observations.

"The review was conducted during 15th to 18th Nov 2021," the company stated in a BSE filing.

Shilpa Medicare Limited, Unit III, R&D facility is involved in development of formulations (generics, complex generics and innovative products) and providing advanced analytical services.

The US Food and Drug Administration (USFDA) had earlier issued a warning letter to Shilpa Medicare for violating current good manufacturing practice norms at its manufacturing plant in Mahabubnagar district in Telangana.

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