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.