Sun Pharma's Ahmednagar plant comes u...
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Jul
15
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Sun Pharma’s Ahmednagar plant comes under USFDA scanner
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Sun Pharma  ‘s Active Pharma Ingredients plant in Ahmednagar was audited by the American drug regulator USFDA last month. CNBC-TV18’s Archana Shukla reports that there have been some minor observations noted by the USFDA in its audit, however, the observations are not severe enough in nature and may not hinder product approvals.   Sun Pharma’s Ahmednagar facility primarily makes raw ingredients for oncology products.   Sources say that the current audit may have been in response to a product filing made by Sun Pharma’s R&D spin off unit SPARC. CNBC-TV18, however, has not been able to independently verify this.   It becomes important to highlight the current audit as Sun Pharma’s formulation unit in Halol is still under the USFDA scanner. Sun Pharma is also working to gain conditional approvals from USFDA for certain products that were filed from its Halol facility and is also looking for site transfers for some products. Hence audits at other facilities become relevant to track.   The market has been abuzz with speculation on a possible positive movement on Halol too. However, there has been no confirmation of any follow up inspections by USFDA at Halol yet.   The company at its end did not offer any comments on this story.



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