Shilpa Medicare's Unit VI Receives EIR from USFDA Regulations, 2015

Shilpa Medicare Ltd's Unit VI, located in Bengaluru, has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) under the USFDA Regulations, 2015. The unit, which is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms - Oral Dissolving Films and Transdermal Systems, received the EIR with a Voluntary Action Indicated (VAI) classification. This facility is already approved by EMA, Europe; MHRA, UK; SFDA, Saudi and TGA, Australia. It is currently supplying Oral Film products to the US and other markets, while Transdermal products have been filed in the European market.