Natco gets one USFDA observation for Kothur facility

Drug firm-Natco Pharma announced that United States Food and Drug Administration (USFDA) had completed its pre-approval inspection conducted at its formulation facility in Kothur Village from March 2 to 6, 2020 and have issued one observation to the company.

Natco clarified that the observation received from US regulator related to equipment qualification of a co-mill used in the process had an operating speed slightly outside the qualification range. The company believes that this is a minor observation and can be addressed within a short period of time.

For the quarter ended December 2019, the company reported an 11.55 per cent drop in the consolidated total income to Rs 513 crore from Rs 580 crore in Q3FY20. In the most recent quarter, the company reported a 34.46 per cent drop in consolidated net profits to Rs 104.4 crore from Rs 159.3 crore in the same period for the previous quarter. The company continues to face margin pressures due to its Hepatitis C portfolio.

Natco Pharma (Natco) Limited manufactures a comprehensive range of branded and generic dosage forms, bulk actives and intermediates for both Indian as well as international markets.

At 1:45 pm on Monday, the stock was trading at Rs 589.90, down by 1.82 per cent or Rs 10.95 per share. The 52-week high is recorded at Rs 737.80 and the 52-week low is Rs 482 on BSE.