Cipla unit's US facility receives 5 observations from American drug regulator; shares fall
Cipla shares remained under pressure on Thursday after the US drug regulator issued five observations about a New York-based facility of the company's wholly-owned subsidiary, InvaGen Pharmaceuticals.
Cipla shares remained under pressure on Thursday, after the US drug regulator issued five observations about a New York-based facility of the company's wholly-owned subsidiary, InvaGen Pharmaceuticals. The Cipla stock declined by as much as Rs 35, or 2.8 per cent, to Rs 1,203.9 apiece on BSE in an overall weak Mumbai market, before settling at Rs 1,209.9 apiece for the day.
In a regulatory filing post-market hours on Wednesday, Cipla said the US Food and Drug Administration (USFDA) conducted a "routine current good manufacturing practices (cGMP)" inspection at InvaGen Pharmaceuticals' manufacturing facility located in Central Islip in Long Island, New York, from September 11 to September 19. The regulator also conducted a pre-approval inspection for a site transfer product within InvaGen.
After the completion of the inspection, InvaGen received five observations in Form 483 from the FDA. "There are no repeat or data integrity (DI) observations. The Company will work closely with the USFDA and is committed to addressing these comprehensively within stipulated time," the filing added.
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Form 483, also known as the notice of inspectional observations, is issued at the end of an inspection by the US health regulator in cases where the field authorities come across deficiencies in quality systems, or find conditions violating food and drug safety laws.
(This story will be updated shortly)