Strides Pharma gets two US FDA observations after Chennai plant inspection

Observations made during these inspections are common and do not necessarily imply any significant non-compliance issues.
Strides Pharma gets two US FDA observations after Chennai plant inspection

Strides Pharma Science Limited, a leading pharmaceutical company, announced today that its wholly-owned subsidiary, Strides Alathur Private Limited, received two observations during a routine current Good Manufacturing Practices (cGMP) inspection conducted by the United States Food and Drug Administration (USFDA). The inspection took place at the company's formulations facility in Alathur, Chennai, from April 1 to April 5, 2024.

The USFDA conducts regular inspections of pharmaceutical manufacturing facilities to ensure compliance with cGMP regulations. Observations made during these inspections are common and do not necessarily imply any significant non-compliance issues.

Companies are required to address these observations and provide a detailed response to the regulatory agency. The agency then takes a final decision before closing the matter.

Strides Pharma Science stated that the company would comprehensively respond to the observations within the stipulated time and will keep investors updated.

Strides Pharma Science Limited is a global pharmaceutical company headquartered in Bangalore, India, with a focus on developing and manufacturing a wide range of IP-led niche pharmaceutical products. The company has a strong presence in the regulated markets of the United States, Europe, and Australia, as well as in emerging markets.

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