Cipla Shares Fall 4% After USFDA Issues Form 483 to Partner Pharmathen Facility
Cipla shares declined 4% following FDA's Form 483 issuance to manufacturing partner Pharmathen's Rodopi facility, highlighting nine serious cGMP compliance violations including microbiological contamination risks and data integrity concerns. The facility manufactures Lanreotide, Cipla's largest US product, raising supply chain disruption concerns among investors.

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Cipla shares declined 4.00% on Wednesday, trading at ₹1,471.50 per share, following the US Food and Drug Administration's issuance of Form 483 to Pharmathen's Rodopi facility. The regulatory action has intensified investor concerns about potential supply chain disruptions for the company's largest US market product, Lanreotide.
FDA Form 483 Observations at Rodopi Facility
The US FDA inspection at Pharmathen's Rodopi facility resulted in nine critical observations highlighting serious current Good Manufacturing Practices (cGMP) violations. The Form 483 document reveals systemic compliance deficiencies that pose significant risks to product quality and patient safety.
| Key FDA Observations: | Details |
|---|---|
| Microbiological Contamination: | Risks involving gram-negative bacteria |
| Aseptic Practices: | Poor aseptic processing procedures |
| Particulate Control: | Higher particulate reject limits |
| Batch Quality: | Rejected batches identified |
| OOS Investigations: | Inadequate out-of-specification result investigations |
| Data Integrity: | Potential data integrity challenges flagged |
| Contamination Prevention: | Inadequate contamination control procedures |
| Sterile Conditions: | Weak sterility maintenance systems |
| Laboratory Controls: | Deficiencies in quality control procedures |
Market Performance and Trading Activity
Cipla shares fell as much as 4.00% to ₹1,467.50 during Wednesday's trading session, significantly underperforming the NSE Nifty 50 Index, which declined only 0.31%. The stock's trading volume reached 1.04 times its 30-day average, indicating heightened investor activity following the regulatory disclosure.
| Market Metrics: | Current Status |
|---|---|
| Share Price Decline: | 4.00% |
| Current Trading Price: | ₹1,471.50 |
| Day's Low: | ₹1,467.50 |
| Trading Volume: | 1.04x 30-day average |
| Relative Strength Index: | 62.40 |
| Nifty 50 Performance: | -0.31% |
Lanreotide Revenue Risk and Partnership Impact
Pharmathen's Rodopi facility serves as the exclusive manufacturing site for Cipla's Lanreotide, which represents the company's largest product in the US pharmaceutical market. Any operational disruption at this facility could significantly impact Cipla's US revenue stream and market position in the competitive oncology segment.
Analyst Recommendations and Price Targets
Despite the current regulatory concerns, analyst sentiment remains cautiously optimistic. Out of 39 analysts tracking Cipla, 21 maintain 'buy' ratings, 10 recommend 'hold' positions, and eight suggest 'sell' ratings. The average 12-month consensus price target of ₹1,664.28 implies a potential upside of 13.40% from current levels, suggesting confidence in the company's ability to address compliance issues and maintain long-term growth prospects.
Historical Stock Returns for Cipla
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| -0.50% | -3.35% | -3.96% | -3.30% | -2.46% | +76.71% |
















































