Aurobindo Pharma gets 10 observations from USFDA for its Unit 3 at Hyderabad

Published On 2019-06-05 06:58 GMT   |   Update On 2019-06-05 06:58 GMT

New Delhi: Drug firm Aurobindo Pharma Tuesday said it has received 10 observations from the US health regulator for its Unit 3 in Hyderabad.


The United States Food and Drug Administration (USFDA) conducted an inspection at company's Unit III, a formulation manufacturing facility located at Bachupally, Hyderabad, from May 13 to May 24, 2019, Aurobindo Pharma said in a filing to the BSE.


"The company has received a 'Form 483' with 10 observations," it added.


Read Also: Aurobindo Pharma: USFDA designates 3 facilities as ‘Official Action Indicated’


None of the observations are repetitive and are more procedural in nature, Aurobindo Pharma said.


The drug firm, however, did not provide any details about the observations made by the regulator.


"The company will be responding to the USFDA within the stipulated time. The Form 483 will not have an impact on existing business of this facility," Aurobindo Pharma said.


Shares of Aurobindo Pharma closed at Rs 654.10 per scrip on the BSE, down 0.48 per cent from its previous close.


Read Also: Patent Infringement: AstraZeneca moves court against Aurobindo Pharma on generic version of Daliresp


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