Jubilant Lifesciences: USFDA indicates action against Mysuru units

The pharma company's plant in Nanjangud, Mysuru was classified as 'Official Action Indicated' (OAI) by the US drug regulator following which the stock was experiencing selling pressure on Friday.

The US Food and Drug Administration (USFDA) issued a communication on March 13 following an inspection conducted at the Jubilant Generics Limited (JGL) in December 2018. The USFDA has given the company's API manufacturing plant in Nanjangud, Mysore OAI status. The regulator can now initiate action including withholding of pending approvals for products manufactured at this plant. The plant may also face cGMP (Good Manufacturing Practice) regulatory action.

However, the company believe this USFDA action will not have an impact on the company's existing revenues from operations of this facility. Also, the company can engage with the regulator in a timespan of 40 days to seek a downgraded from the OAI status.

Earlier this month, USFDA issued a warning letter to the company's wholly-owned subsidiary's plant in Roorkee. The facility is a solid dosage formulations plant, which received an OAI status in December 2018.

Jubilant Lifesciences Limited (JLL), an integrated pharma company engaged in pharmaceuticals, life science ingredients, drug discovery in the global market and manufacturing of branded pharmaceutical in India.

Reacting to this development, in the early morning session on Friday, the stock of Jubilant Lifesciences was down 2.50 per cent. At 10:11 hours, the stock recovered a bit and was quoting Rs. 761.95 per share, down by Rs. 13.30 or 1.72 per cent on BSE.