Shilpa Medicare has received EIR with VAI (voluntary action indicated) classification for Unit VI, Dabaspet, Bengaluru, Karnataka, from U.S. Food and Drug Administration (USFDA). The GMP inspection was conducted from October 24-30, 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.
Shilpa Medicare produces and exports consistently high-quality Active Pharmaceutical Ingredients Fine Chemicals, intermediates, herbal products and speciality chemical products using sophisticated technology, meticulously following international specifications.
