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Motilal Oswal Report
The U.S. Food and Drug Administration issued form 483 to Cipla Ltd. for its Pithampur site and we assessed that the observations are primarily related to inadequate root cause analysis, handling of market complaints, upgrading of software and gross margin profit records.
We expect Cipla to implement strong corrective and preventive actions to resolve the issues.
We cut our earnings estimate by 3% for FY24 to factor in the delay in g-Advair approval, due to observations in form 483. The Official action indicated at Goa and the recent form 483 at Indore increase the overall regulatory risks from U.S. generics business perspective. Accordingly, we reduce the price-to-earnings multiple to 21 times from 23 times.
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