Aurobindo Pharma’s API unit in Telangana gets 2 US FDA observations – CNBC TV18
Pharmaceutical company Aurobindo Pharma Ltd on Tuesday (December 17) announced that the United States Food and Drug Administration (FDA) completed an inspection of Unit-V, an active pharmaceutical ingredient (API) manufacturing facility of its wholly-owned subsidiary, Apitoria Pharma Private Ltd.
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“The United States Food and Drug Administration (US FDA) inspected Unit-V, an API manufacturing facility, of Apitoria Pharma Private Limited, a wholly-owned subsidiary of the Company, situated at Pashamylaram Village, Patancheru Mandal, Sanga Reddy District, Telangana from December 09 to December 17, 2024,” Aurobindo Pharma said in a regulatory filing.
Also Read: Aurobindo Pharma, Glenmark recall products in US
The inspection, conducted from December 9-17, 2024, took place at the company’s facility located in Telangana. The FDA closed the inspection with two observations, which are described as procedural in nature. Aurobindo Pharma said the company will respond to these observations within the stipulated time frame.
“The inspection closed with 02 observations. The observations are of procedural in nature and will be responded to within the stipulated time. We will keep the stock exchanges informed if there is any further information relating to the above in the future,” it said. Aurobindo Pharma has committed to keeping the stock exchanges informed of any further updates regarding the inspection.
Also Read: Aurobindo Pharma arm CuraTeQ gets European body’s nod for filgrastim biosimilar
Shares of Aurobindo Pharma Ltd ended at ₹1,212, down by ₹33, or 2.65%, on the BSE.
(Edited by : Shoma Bhattacharjee)
