Aurobindo Pharma restarts aseptic product distribution; shares trade higher

Aurobindo Pharma share price gained in opening trade on March 13 as the company's subsidiary restarted distribution of aseptic products.

At 09:27 am, Aurobindo Pharma was quoting at Rs 1,047.75, up Rs 3.45, or 0.33 percent, on the BSE.

Eugia Pharma Specialities Ltd., a wholly-owned subsidiary, has started distribution of aseptic products manufactured at Unit III, which was temporarily suspended.

The company also expects to start commercial production from the aseptic lines of the said facility in a phased manner beginning next week and restart all the lines by April 15, 2024.

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

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

On March 1, the company received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Fingolimod Capsules, 0.5 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation. The product will be launched in March 2024.