Mumbai-based Lupin gets FDA warning for two manufacturing sites; Ionis promotes inotersen head as new COO
→ Indian drug manufacturer Lupin received a warning letter from the FDA claiming that it had violated good manufacturing practices, the company disclosed in a filing to the Bombay Stock Exchange. Two facilities in Goa and Indore, which produce products that make up more than 40% of Lupin’s sales, were named in the letter. “This is a big negative for the company… The warning letter will not only delay new approvals, thus impacting US revenues, but also increase remediation cost that will put pressure on margins,” brokerage firm Edelweiss Securities is quoted as saying. That would take a direct hit on the Mumbai-based company, as almost half of its sales comes from the US. Stocks plunged 17% after the news broke.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.