Shilpa Medicare clears USFDA review for Dabaspet facility

Published On 2021-11-20 07:32 GMT   |   Update On 2021-11-20 07:42 GMT
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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.
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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.

Read also: Shilpa Medicare Gets USFDA Warning For CGMP Violations At Telangana Unit

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.

Read also: Shilpa Medicare gets WHO-Geneva nod for API Praziquental to treat blood, liver fluke

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