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Sun Pharma shares fell 1.7 per cent after the US health regulator warned the company it may withhold approval of new drug applications and extend an import ban at its Karkhadi unit in Gujarat if violations of manufacturing norms at the facility are not corrected.
Sun Pharma’s stock ended 1.73 per cent lower at Rs 577.15 on the BSE. During the day, it lost 2 per cent to Rs 575.20.
On the National Stock Exchange, the scrip went down by 1.69 per cent to end at Rs 577.45.
The US Food and Drug Administration said there were reasons to suggest a general lack of reliability and accuracy of data, including missing fundamental raw data, unacceptable data handling practice and inadequate investigation into ‘the pervasive practice of deleting (raw) files’
“Until all corrections have been completed and FDA has confirmed corrections of the violations and deviations and your firm’s compliance with CGMP (current good manufacturing practice), FDA may withhold approval of any new applications or supplements listing your firm as a drug product or an API manufacturer,” USFDA said yesterday.
Failure to correct the violations and deviations may result in FDA continuing to refuse admission of articles manufactured at Karkhadi into the US, it said.
The letter followed a USFDA review of Sun Pharma’s initial response to issues raised during an inspection of the facility in November last year.
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