Shilpa Medicare's Bengaluru Unit Gets Positive USFDA Nod, Stock Up 4.8%! 📈

Hey investors! Got some exciting news from Shilpa Medicare (SHILPAMED) that’s sure to catch your eye. The company just announced a positive outcome from a recent USFDA inspection for its Bengaluru-based Unit VI! 🎉

For those new to pharma lingo, the USFDA’s ‘Voluntary Action Indicated’ (VAI) classification is fantastic news. It means that while the FDA might have noted some observations during their inspection (which happened from October 24-30, 2024), they aren’t planning any regulatory action. Essentially, it’s a green light, confirming the facility’s compliance and operational quality. ✅

This particular unit in Dabaspet, Bengaluru, is a powerhouse! It’s equipped for manufacturing, packaging, testing, storage, and distribution of two complex dosage forms: Oral Dissolving Films and Transdermal Systems. Think of those quick-dissolving strips or patches that deliver medicine – that’s what they do! 💊

What’s even more impressive is that this unit isn’t new to global standards. It’s already approved by major regulatory bodies like EMA (Europe), MHRA (UK), SFDA (Saudi), and TGA (Australia). This global stamp of approval truly highlights Shilpa Medicare’s commitment to quality. 🌍

Currently, this unit is already supplying Oral Film products to the US and other international markets. Plus, they’ve got their Transdermal products filed in the European market, signaling exciting growth prospects ahead. 🚀

This positive USFDA nod reinforces Shilpa Medicare’s position as a reliable global player in the pharmaceutical space. Keep an eye on SHILPAMED as they continue to expand their footprint! 👀

source: Corporate Announcement

Join our Telegram for instant updates!