Download Unicorn Signals App

Powered By EquityPandit
 Signals, Powered By  EquityPandit
MARKETS

Aurobindo Pharma Shares Fell 2% Despite Unit Secures WHO GMP Approval

The USFDA inspected Aurobindo Pharma's Unit-II API manufacturing facility from 23rd to 27th September, 2024.

Aurobindo Pharma Limited shares were 2% lower after the company informed over its regulatory filing that its subsidiary APL Healthcare Limited got the World Health Organization’s (WHO) Good Manufacturing Practice (GMP) approval.

GMP ensures products are consistently produced to quality standards for their intended use. It minimises risks in pharmaceutical production, such as cross-contamination, mix-ups, and false labelling. Risk assessment plays a significant role in ensuring patient safety and quality assurance guidelines.

The company has stated in its regulatory filing that the Prequalification Unit Inspection Team (PQT-INS) of the World Health Organization (WHO) inspected Unit IV, a Formulation manufacturing facility of APL Healthcare Limited, a wholly-owned subsidiary of the company. The facility is situated at Menakuru Village, Naidupeta Mandal, Tirupati District, Andhra Pradesh. It was made available from September 11 to September 15, 2023.

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

At 1:50 pm, the shares of Aurobindo Pharma were trading 1.15% lower at Rs 1,052.50 on NSE.

Get Daily Prediction & Stocks Tips On Your Mobile