Shilpa Medicare's Unit VI clears USFDA inspection

Shilpa Medicare announced that its Unit VI, Dabaspet, Bengaluru, has received EIR with VAI (Voluntary Action Indicated) classification, from USFDA, for the GMP inspection which was conducted from 24-30 October 2024.

This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms - Oral Dissolving Films and Transdermal Systems.

The Unit is already approved by EMA, Europe; MHRA, UK; SFDA, Saudi and TGA, Australia.

This Unit is currently supplying Oral Film products to US and other markets. Transdermal products have been filed in the European market.

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