Major pharmaceutical company Lupin disclosed that the US Food and Drug Administration (USFDA) has issued a ‘Form 483’ with three observations following an inspection at its manufacturing site in Somerset, New Jersey. The inspection, conducted from April 13 to April 17, concluded with the issuance of the Form 483 containing the observations. Lupin stated its commitment to addressing these observations within the specified timeframe and maintaining compliance with Good Manufacturing Practices (cGMP) standards.
In a separate instance, the USFDA had recently completed an inspection at Lupin’s Ankleshwar manufacturing facility in India, resulting in the issuance of a Form 483 with two observations. The company had assured that it would respond to these observations within the required timeline while upholding cGMP standards. A Form 483 is typically issued by the USFDA at the end of an inspection when potential violations of the Food, Drug and Cosmetic Act are observed.
Lupin emphasized its dedication to upholding cGMP standards across all its facilities. The company’s stock on the NSE closed at Rs 2,322.50 on Friday, marking a slight decrease of 0.19 percent. Additionally, the pharmaceutical stock had reached a 52-week high of Rs 2,377.60 and a low of Rs 1,836.80 on the exchange.
