Aurobindo to resume production at aseptic lines of Eugia Pharma’s Unit-III

Mar13,2024



Hyderabad: Aurobindo Pharma informed the stock exchanges on Tuesday that it expects to resume commercial production antiseptic lines In Unit-III of the subsidiary company Eujia Pharma Specialties Limited
The company said it has resumed distribution of aseptic products manufactured at Unit-III after its temporary closure in early February this year.
“We expect to commence commercial production from the aseptic lines of the said facility in a phased manner from next week and restart all lines by April 15, 2024,” Aurobindo Pharma said in a regulatory filing.
On February 2, 2024, Aurobindo had informed the stock exchanges that it would be closing down some of Eugeia Pharma's pashamilaram formulation facility in Hyderabad after the US Food and Drug Administration (USFDA) issued nine observations following an inspection from January 22 to 22. Will temporarily stop production on the lines. 2 February 2024.
Aurobindo also said that the World Pre-Qualification Unit Inspection Service Team (PQT-INS). Health The organization has decided to recommend Unit-IV of its wholly owned subsidiary APL to the Prequalification Assessment Team Health care Ltd. will be named as a manufacturing site in the dossier for Dolutegravir, Lamivudine, Tenofovir Disoproxil Fumarate Tablets (50/300/300 mg).
It said the decision was taken by the PQT-INS based on the findings of the inspection and Aurobindo's response thereto.
The WHO PQT-INS inspection was conducted from September 11 to September 15, 2023 at Unit-IV of APL, located at Menkuru village, Naidupeta mandal, Tirupati district, Andhra Pradesh.



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