Cipla Shares Decline After US FDA Issues OAI Classification for Partner Facility

Shares of Cipla traded lower on February 23 after the US Food and Drug Administration (US FDA) categorised the cGMP inspection of Pharmathen International SA’s Rodopi, Greece facility as Official Action Indicated (OAI). The classification follows an inspection conducted in November 2025, during which nine Form 483 observations were issued.

These observations highlighted contamination-related risks, concerns over aseptic processes and potential data integrity issues. The development has implications for Cipla because Pharmathen is its exclusive supply partner for Lanreotide injection in the US market.

US FDA Flags Compliance Concerns at Pharmathen Facility

The US FDA’s OAI classification indicates that regulatory action may be taken based on observed non-compliance at the facility. During the November 2025 inspection, the regulator issued nine Form 483 observations covering deficiencies in contamination control, aseptic handling and data management processes.

These findings require corrective and preventive actions before manufacturing operations can resume. The OAI status also implies that approval of new products or changes from this facility may not proceed until compliance is restored.

Cipla’s Dependency on Pharmathen for Lanreotide Supplies

Pharmathen serves as Cipla’s exclusive supply partner for Lanreotide, a key product for the company in the US market. Any disruption in production directly affects Cipla’s ability to supply the product.

Following the inspection, production at the Rodopi facility has been stopped as the partner undertakes remediation measures. Cipla has clarified that the resumption of manufacturing remains dependent on regulatory clearance from the US FDA.

Management Commentary on Q3 And Production Outlook

After reporting its third-quarter performance, Cipla told CNBC-TV18 that remediation efforts are underway at the partner facility. The company noted that production operations are currently halted until corrective actions are reviewed and approved by regulators.

Management stated that it hopes Lanreotide production may resume by the fourth quarter, although this remains contingent on regulatory timelines. Cipla also indicated that the upcoming quarter may be challenging due to the absence of sales from both generic Revlimid and Lanreotide.

Cipla Share Price Performance

On February 23, 2026, Cipla share price opened at ₹1,335.90, compared to the previous close of ₹1,341.10. During the session, as of 1:42 PM IST, the stock had touched a high of ₹1,335.90 and a low of ₹1,308.80, and was trading at ₹1,324.20, down by 1.26%.

The stock recorded a traded volume of 15.75 lakh shares and a traded value of ₹208.54 crore on the NSE. The market capitalisation stood at ₹1,06,966.32 crore.

Read More: Aurobindo Pharma Unit-VII Receives 9 USFDA Form 483 Observations.

Conclusion

Cipla’s shares weakened on February 23 after the US FDA classified its partner Pharmathen’s facility as OAI following nine observations issued in November 2025. The halt in Lanreotide production has added to near-term challenges, particularly with no expected contribution from generic Revlimid in the fourth quarter.

Management has confirmed that remediation measures are in progress but noted that timelines depend on regulatory assessments. The stock’s year-to-date decline reflects market concerns surrounding product availability and compliance-related uncertainties.

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