Cipla Faces US FDA Inspection at Goa Facility, Gets 6 Observations

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Cipla's Goa facility underwent a US FDA inspection, resulting in six Form 483 observations. The company aims to promptly address these within the set timeframe to resolve regulatory concerns, focusing on the areas of potential non-compliance with standards.

Cipla News Today

Cipla Ltd, a prominent pharmaceutical company, underwent an inspection by the US Food and Drug Administration (USFDA) at its manufacturing facility in Goa, spanning from June 10 to June 21, 2024. The outcome of this inspection included the issuance of six inspection observations documented in Form 483.

Understanding Form 483

Form 483 is a significant regulatory document issued by the US FDA inspectors post-inspection. It lists observations made regarding deviations from current Good Manufacturing Practices (cGMP) at the inspected facility.

These observations are communicated to the company during a closing conference but do not constitute a final decision on compliance.

Explore: Cipla Share Price

Company Response

Despite the observations, Cipla expressed its commitment to collaborating closely with the US FDA to address the identified issues comprehensively within the stipulated time frame. The company emphasised its dedication to resolving these matters promptly to maintain regulatory compliance and uphold quality standards.

Key Data Points About Cipla

Cipla, known for its global presence and focus on sustainable growth, operates in key markets including India, South Africa, North America, and other regulated and emerging markets.

The company's recent financial performance underscores its robust position in the pharmaceutical industry. Cipla reported a 79% increase in consolidated net profit to ₹939.04 crore and a 10% rise in revenue from operations to ₹6,163 crore in Q4 FY24 compared to Q4 FY23.

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