Shares in Mumbai-based pharmaceutical company Lupin Limited fell significantly last week after the company disclosed that they received a serious warning letter from the US Food and Drug Administration (FDA). The letter detailed violations identified following recent inspections of two of the company’s Indian manufacturing facilities.
According to the inspection report, when test results for active pharmaceutical ingredients (APIs) and other products came back negative, the company chose to invalidate them and repeatedly test the products until the desired results were returned. If results were still out-of-specification (OOS), workers at Lupin’s Goa and Indore sites chalked them up to laboratory errors.
“These repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate,” said the FDA warning letter sent to Nilesh Gupta, Managing Director of Lupin. “You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems and processes, and ultimately, the products manufactured, conform to FDA requirements at all your sites.”
According to pharmaceutical consultant Prabir Basu, differences in the frequency of FDA inspections in Indian manufacturing facilities may account for the region’s higher number of warning letters.
“The facilities are not inspected as often as in the US, and the companies often have more warning of when the inspectors are coming,” he told BioPharmaDIVE.
For its part, Lupin seems committed to addressing the issues of GMP compliance identified during the inspections. The company will have 15 days to respond to the warning letter with details of corrective actions taken.
“We uphold quality and compliance issues with the utmost seriousness and remain fully committed to be compliant with cGMP quality standards across all our facilities,” Lupin said a statement to the National Stock Exchange of India. “We plan to address the concerns raised by the USFDA expeditiously and will work with the USFDA to resolve these issues a the earliest.”