FDA
U.S Food and Drug Administration said that Bangalore-based company, Semler Research has fudged data during the clinical research of drugs. epresentational Image]Reuters

Indian drug maker NATCO Pharma said Sunday that its current and future products would not be adversely affected by the recent observations made by the U.S Food and Drug Administration (USFDA). The USFDA had carried out an inspection of the quality and handling techniques of its products at two of the company's manufacturing facilities.

NATCO Pharma informed the Bombay Stock Exchange in a filing that an inspection was conducted by the USFDA between February and March, 2016 at its Active Pharmaceutical Ingredients (API) manufacturing facility at Manali near Chennai, and the Pharmaceutical Formulations facility at Kothur village of Mahbubnagar district near Hyderabad.

The Indian drug company said it received 483 observations for both the facilities, which it termed as minor in nature. "The company has already sent response and compliance report for these observations and believes that there would be no adverse impact to its current or future pipeline products coming from these facilities," a corporate filing said.

The USFDA made eight observations while inspecting the NATCO Pharma's Mahbubnagar plant, which manufactures finished dose drugs, the Moneycontrol reported. Mahbubnagar, which is NATCO Pharma's only drug formulations manufacturing plant, contributes 10 percent to the firm's total sales.

Meanwhile, the shares of the NATCO Pharma slumped by Rs 60 or 12.6 percent to Rs 408 from its previous close on the BSE at 11.18 a.m. The company recorded an aggregate of Rs 281.40 crore in consolidated net revenues for the quarter which ended Dec.31, 2015, as against Rs 202.80 crore during the same quarter in 2014, registering an increase of about 38.75 percent, an official statement said.