Pharma major Lupin said it a warning letter from the US Food and Drug Administration for its formulations manufacturing facilities in Goa and Indore on Monday.
“We are deeply disappointed to hove received this outcome. While there will be no disruption of existing product supplies from either of these locations, there will likely be a delay of new product approvals from these two facilities,” it said.
“We plan to address the concerns raised by the USFDA expeditiously and will work with the USFDA to resolve these issues of the earliest,” it said.
The company had, in April and May, received three Form 483 observations in Goa and six Form 483 abservotions in Pithampur.
Form 483 is issued to firm management at the conclusion of an inspection when an investigator has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Observations are made when in the investigator’s judgment, conditions or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.
Companies have to respond to the FDA Form 483 in writing with their corrective action plan and then implement the action.
“We uphold quality and compliance issues with utmost seriousness and remain fully committed to be compliant with cGMP quality standards across all our facilities,” the company said in a statement today.
Shares of Lupin were down 15% at Rs 880.80 on the news.
Lupin Limited is a transnational pharmaceutical company based in Mumbai. It is the seventh-largest company by market capitalization;and the 10th-largest generic pharmaceutical company by revenue globally.
It is the fifth-largest generic pharmaceutical company in the US by prescription-led market share and 3rd largest Indian pharmaceutical company by revenue.
It is also one of the fastest growing generic pharmaceutical players in the US and Japan; and is the 4th largest and the fastest growing generic pharmaceutical player in South Africa.