On March 12, Aurobindo Pharma’s share price remained largely unchanged after the company’s subsidiary received approval from the World Health Organization (WHO) for Good Manufacturing Practices (GMP).
As of 09:56 am, Aurobindo Pharma was trading at Rs 1,063.90 on the BSE, down Rs 0.45 or 0.04 percent.
The WHO’s Prequalification Unit Inspection Team (PQT-INS) inspected Unit IV, a formulation manufacturing facility of Aurobindo Pharma’s wholly-owned subsidiary, APL Healthcare, located in Menakuru Village, Naidupeta Mandal, Tirupati District, Andhra Pradesh. The inspection took place between September 11 and September 15, 2023.
Following the inspection findings and the company’s response, the PQT-INS recommended to the Prequalification Assessment Team that the aforementioned facility be designated as a manufacturing site in the dossier for Dolutegravir, Lamivudine, Tenofovir Disoproxil Fumarate Tablets (50/300/300 mg), according to a statement by Aurobindo Pharma.
On March 1st, the company secured final approval from the US Food & Drug Administration (USFDA) to produce and market Fingolimod Capsules, 0.5 mg. These capsules are bioequivalent and therapeutically equivalent to Novartis Pharmaceuticals Corporation’s reference listed drug (RLD), Gilenya Capsules, 0.5 mg. The product is slated for launch in March 2024.
Meanwhile, in February, the company underwent a scrutiny by the United States Food and Drug Administration (USFDA) at the injectable facility managed by Eugia SEZ Pvt Ltd, a 100 percent step-down subsidiary of Aurobindo Pharma Ltd, located in Polepally Village, Mahaboobnagar district, Telangana. The inspection, conducted from February 19th to 29th, resulted in the company receiving seven observations.
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