USFDA conducts inspection at two manufacturing facilities of Natco Pharma

The United States Food & Drug Administration (USFDA) has conducted inspection at two manufacturing facilities of Natco Pharma recently. The inspection was conducted at the Active Pharmaceutical Ingredients (API) manufacturing facility at Manali, near Chennai, and the Pharmaceutical Formulations facility at Kothur, near Hyderabad, during early February and March, 2016, respectively.

The company has received 483 observations for both facilities and believes them to be of 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.

Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets.