Sun Pharma's Halol plant still under US FDA's import alert
Sun Pharma's big manufacturing site in Gujarat is still on the US FDA's import alert list as of September 2025.
After a June inspection, the FDA found ongoing issues related to non-compliance with current good manufacturing practices (cGMP), raising concerns about product safety and quality.
Exports to the US blocked
The Halol plant has faced these restrictions for an extended period, with most exports to the US blocked except for a few products in shortage.
The site has been under close FDA scrutiny, making it tough for Sun Pharma to ship from there.
Share price nudged up a bit
Sun Pharma says it's working to fix things and get back on track.
Despite these troubles, their shares actually nudged up a bit (closing at ₹1,594 on September 9).
Financially, they posted strong revenue growth this quarter but took a profit hit due to a one-time charge—showing they're not out of the woods yet.