GRANULES

nules shares fall 8% as US FDA issues warning letter after inspection at firm's Gagillapur facility

The shares of

India crashed over 8 percent on February 28 after the company announced that it has received a warning letter from the US Food and Drug Administration (FDA) for its Gagillapur facility in Hyderabad, following an inspection conducted in August ***** an exchange filing released in the post market hours of February 27, the pharmaceutical company announced that the US FDA had issued the letter the previous day. While the facility remains classified as "Official Action Indicated" (OAI), the regulator has not signalled any further escalation, the statement read. Granules added that manufacturing and distribution of its existing products at the facility will continue unaffected. However, the warning letter may temporarily impact FDA's review of its pending product submissions from the site until the issue is resolved. "We will respond within the stipulated timeframe and seek a meeting with the FDA to demonstrate ongoing progress towards compliance. We remain confident that this matter will be resolved satisfactorily within a reasonable timeframe," Granules further ***** warning letter highlighted four key concerns from the initial six observations noted in the FDA's Form 483. Granules has claimed that it has made significant progress in addressing these issues, with most corrective measures completed and the remaining ones on track. The company has also been providing monthly updates to the regulator.