Aurobindo Pharma Subsidiary Restarts Aseptic Product Distribution

13 Mar 2024 , 02:55 PM

The opening price of Aurobindo Pharma’s shares increased on March 13 due to the company’s subsidiary beginning aseptic product distribution again.

Aurobindo Pharma was trading at ₹1,019.75 on the BSE at 14:13 pm, down  ₹25.40, or 2.43%.

Unit III’s aseptic product distribution has been resumed by Eugia Pharma Specialities Ltd., a wholly-owned subsidiary, following a temporary suspension.

Additionally, the business plans to gradually resume commercial production from the facility’s aseptic lines starting next week and to fully restart all of the lines by April 15, 2024.

The World Health Organization’s (WHO) prequalification Unit Inspection Team (PQT-INS) inspected Unit IV, located at Menakuru Village, Naidupeta Mandal, Tirupati District, Andhra Pradesh, between September 11 and September 15, 2023, and on March 11 the company’s arm, APL Healthcare, received WHO GMP approval.

The PQT-INS has determined to recommend to the Prequalification Assessment Team that the aforementioned facility be listed as a manufacturing site in the dossier for Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets (50/300/300 mg) based on the inspection findings and response to the same, the company said.

The US Food and Drug Administration (USFDA) gave the company final approval on March 1 to produce and sell Fingolimod Capsules, 0.5 mg, which are therapeutically and bioequivalent to Novartis Pharmaceuticals Corporation’s Gilenya Capsules, 0.5 mg, the reference listed drug (RLD). In March 2024, the product will be introduced.

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