USFDA observations on 2 units not to impact products: Natco

Published On 2016-03-28 06:33 GMT   |   Update On 2016-03-28 06:33 GMT
New Delhi : Natco Pharma Ltd said it has received "minor" observations by US Food & Drug Administration (USFDA) following recent inspections at its two facilities and they 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 Active Pharmaceutical Ingredients (API) manufacturing facility at Manali, near Chennai, and the Pharmaceutical Formulations facility at Kothur, near Hyderabad, in early February and March 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.
Article Source : PTI

Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News