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

by The Technical Blogs


HYDERABAD: Aurobindo Pharma on Tuesday informed the bourses that it expects to recommence commercial production at the aseptic lines at Unit-III of subsidiary Eugia Pharma Specialities Ltd.
The company said it has restarted distribution of aseptic products manufactured at Unit-III after it was temporarily stopped in early Feb this year.
“We also expect to start commercial production from the aseptic lines of the said facility in a phased manner beginning next week and to re-start all the lines by April 15, 2024,” Aurobindo Pharma said in a regulatory filing.
On February 2, 2024, Aurobindo had informed the stock exchanges that it will be temporarily halting production on certain lines of Eugia Pharma’s Pashamylaram formulations facility in Hyderabad after the US Food & Drug Administration (USFDA) issued nine observations following an inspection from January 22 to February 2, 2024.
Aurobindo also said that the pre-qualification unit inspection services team (PQT-INS) of World Health Organisation has decided to recommend to the prequalification assessment team that Unit-IV of its wholly owned subsidiary, APL Healthcare Ltd, be named as a manufacturing site in the dossier for Dolutegravir, Lamivudine, Tenofovir Disoproxil Fumarate Tablets (50/300/300 mg).
The decision was taken by PQT-INS based on the inspection findings and Aurobindo’s response to the same, it said.
The WHO PQT-INS inspection was conducted at APL’s Unit-IV, which is located at Menakuru village, Naidupeta mandal of Tirupati district in Andhra Pradesh, from September 11 to September 15, 2023.


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