The classification was communicated to the company via email on 4 August 2025. The inspection was conducted under the USFDA’s current Good Manufacturing Practices (cGMP) framework from 26 May to 30 May 2025. In an earlier exchange filing dated May 30, Cipla had disclosed that the inspection concluded with one observation issued in Form 483.
The company reiterated its commitment to compliance and stated that it will work closely with the USFDA to address the observation comprehensively within the stipulated timeframe.
Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolios in our home markets of India, South Africa, North America, and key regulated and emerging markets.
Cipla reported 10.18% increase in consolidated net profit to Rs 1,297.62 crore on a 3.93% rise in total revenue from operations to Rs 6,957.47 crore in Q1 FY26 over Q1 FY25.
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