The inspection comprised a routine current Good Manufacturing Practices (cGMP) review along with a Pre-Approval Inspection (PAI), the company said in a regulatory filing.
Following the conclusion of the inspection, the company received two observations in Form 483.
Cipla stated that it will work closely with the USFDA and is committed to addressing the observations comprehensively within the stipulated timeline.
Earlier on March 9 , the pharma major had informed that its wholly-owned subsidiary, Cipla USA Inc., has initiated a recall of unexpired batches of Lanreotide injection. The move will lead to a temporary shortage of the medicine in the market.
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Before that in a separate development on March 2, the pharma company entered a 60:40 joint venture agreement with Kemwell Biopharma Private Limited, to incorporate a joint venture company in India.
The proposed JV will focus on developing, applying for and obtaining licenses for manufacturing, commercialising, importing, and exporting biologic products, as well as licensing or outsourcing any of these activities.
In its Q3FY26 results, net profit for the period fell 57% from last year to ₹675.8 crore from ₹1,570.5 crore last year. Company’s profitability has also taken a hit due to the one-time cost due to the new labour code, which was ₹276 crore during the quarter.
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Before the exchange filings, Cipla Limited/span> shares ended higher on April 17, with the stock closing at ₹1,244.50 on the NSE, up ₹14.00 or 1.14% for the day.
