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Goa Facility Faces USFDA Scrutiny with Two Observations
17 Apr
Summary
- USFDA inspected Cipla's Verna, Goa facility from April 6-17, 2026.
- The inspection resulted in two observations documented on Form 483.
- Cipla commits to addressing USFDA observations within the timeline.
Cipla Limited's manufacturing facility in Verna, Goa, was the subject of a US Food and Drug Administration (USFDA) inspection from April 6 to April 17, 2026. This inspection encompassed a routine current Good Manufacturing Practices (cGMP) review, alongside a Pre-Approval Inspection (PAI).
Following the conclusion of the inspection period, Cipla received two observations documented on a Form 483. The company has stated its commitment to working closely with the USFDA and addressing these observations thoroughly within the specified timeframe.
In other recent developments, Cipla announced on March 9, 2026, that its subsidiary initiated a recall of Lanreotide injection batches, potentially leading to a temporary market shortage. The company also entered a joint venture agreement with Kemwell Biopharma Private Limited on March 2, 2026, to develop and commercialize biologic products.
Earlier, the company reported a 57% decrease in net profit for Q3FY26, amounting to ₹675.8 crore, partly due to a one-time ₹276 crore cost associated with the new labor code. Despite these events, Cipla Limited shares closed higher on April 17, 2026, at ₹1,244.50 on the NSE.
