Aurobindo Pharma arm gets WHO GMP approval; shares flat

The Prequalification Unit Inspection Team (PQT-INS) of World Health organization (WHO) had conducted an inspection at the Unit IV from September 11 to September 15, 2023.

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Aurobindo Pharma share price was trading flat on March 12 after the company’s subsidiary received WHO GMP approval.

At 09:56 am Aurobindo Pharma was quoting at Rs 1,063.90, down Rs 0.45, or 0.04 percent, on the BSE.

The Prequalification Unit Inspection Team (PQT-INS) of the World Health organization (WHO) had inspected the Unit IV, a formulation manufacturing facility of a wholly owned subsidiary, APL Healthcare, situated at Menakuru Village, Naidupeta Mandal, Tirupati District, Andhra Pradesh, between September 11 and September 15, 2023.

Based on the inspection findings and our 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.

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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.

In February, the company received seven observations from the United States Food and Drug Administration (USFDA) after inspecting the injectable facility of Eugia SEZ Pvt Ltd, a 100 percent step-down subsidiary of Aurobindo Pharma Ltd, at Polepally Village in Mahaboobnagar district of Telangana, from February 19 to 29.