In Short:
Sun Pharmaceuticals has received a warning letter from the FDA for its Dadra facility due to violations of manufacturing regulations. The contents of the letter will be made public by the USFDA. Sun had previously received an Official Action Indicated status in April. Shares of Sun were down by 1.90% on Thursday. Sun had undergone an inspection in December which led to the OAI status.
Sun Pharmaceuticals Receives Warning Letter from USFDA
Exciting times over at Sun Pharmaceuticals as they have just received a letter from the United States Food and Drug Administration for their Dadra facility. The letter points out violations in Current Good Manufacturing Practice (cGMP) regulations, but don’t worry, Sun is on it!
Stay Informed
In a statement to the BSE, Sun mentioned that the full contents of the letter would be made public by the USFDA in the near future. This update comes after their previous communication on April 11, 2024, where they informed about the Dadra facility receiving an Official Action Indicated (OAI) status.
Market Impact
On Thursday, Sun’s shares took a slight dip, down 1.90 per cent at ₹1,475.50 on the BSE at 12.27 pm. But we all know they’ll bounce back stronger!
Recap
Earlier in April, the Dadra facility underwent an inspection by the USFDA from December 4, 2023, to December 15, 2023. Following the inspection, the US regulator classified it under the OAI status. Sun had assured that they are committed to working with the regulator to ensure full compliance.
It’s all part of the journey towards ensuring top-notch quality and we are confident that Sun Pharmaceuticals will overcome this hurdle with their dedication and commitment!
