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Natco units get Food & Drug Administration observations
City-based Natco Pharma Ltd on Sunday said it had received minor observations by US Food & Drug Administration (USFDA) following recent inspections at its two facilities. The company however will not have an adverse impact on its current or future products.
Hyderabad: City-based Natco Pharma Ltd on Sunday said it had received minor observations by US Food & Drug Administration (USFDA) following recent inspections at its two facilities. The company however will not have an adverse impact on its current or future products.
An inspection was conducted by the USFDA in two of its facilities recently - the pharmaceutical formulations facility at Kothur near Hyderabad and active pharmaceutical ingredients (API) manufacturing facility at Manali, near Chennai in early March and February respectively, Natco said in a statement.
"The company has received 483 observations for both facilities and believes them to be of minor in nature," it said. Natco 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, it added.
