Pharma major Cipla saw its shares lose out at the bourses on Thursday after a wholly-owned subsidiary of the company, InvaGen Pharmaceuticals Inc., underwent a thorough inspection by the United States Food and Drug Administration (USFDA). This inspection, which spanned from September 11 to 19, 2023, took place at InvaGen’s manufacturing hub nestled in Central Islip, Long Island, New York.
So, what was the USFDA looking for? Primarily, they were checking on two fronts. First, they wanted to ensure that InvaGen was up to par with the routine Current Good Manufacturing Practices (cGMP). Secondly, they were keen on a Pre-Approval Inspection (PAI) that zeroes in on the transfer of a specific product within InvaGen’s lineup.
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The outcome? InvaGen received five inspectional observations, documented in what’s known as Form 483. But here’s the silver lining: none of these observations were repeats, and there weren’t any red flags raised about data integrity.
InvaGen has pledged to collaborate closely with the USFDA, ensuring they address these observations head-on and within the set timeframe.
Price Action: Cipla Ltd. shares were trading 1.83% lower at ₹1,217 shortly after markets opened for trading on Thursday.
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