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Motilal Oswal Report
Recently, the U.S. Food and Drug Administration inspected the Halol site of Sun Pharmaceutical Industries Ltd. and issued Form 483 with 10 observations.
The observations were largely related to media-fill studies, improvement in aseptic operations, cleaning and maintenance of equipment, personnel training and inadequate root cause analysis.
Halol contributed about 3-4% of Sun Pharma’s consolidated revenue and had 19 abbreviated new drug applications pending for approval (in March 2020).
We expect a timeline of three-six months to resolve the issues highlighted in Form 483.
While Halol-related regulatory issue could be an area of concern over the near term, steady scale-up in specialty portfolio across global markets and superior execution in branded generics across India/rest of world markets bode well for 13% earnings compound annual growth rate over FY22-24E.
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