Aurobindo Pharma's Bhiwadi Facility Under FDA Scrutiny: Understanding the Observations

▴ Aurobindo Pharma's Bhiwadi Facility Under FDA Scrutiny
Aurobindo Pharma reassured stakeholders that it would address these observations within the stipulated time frame.

Aurobindo Pharma, a leading pharmaceutical company, recently announced that it received seven observations from the United States Food and Drug Administration (US FDA) for its unit-II formulation manufacturing facility located in Bhiwadi, Rajasthan. The FDA conducted an inspection of the facility from April 25 to May 3, 2024, resulting in the issuance of these observations.

The Bhiwadi facility, operated by Eugia Pharma Specialities Ltd, a wholly-owned subsidiary of Aurobindo Pharma, underwent scrutiny by the US FDA. According to the company's exchange filing, the observations from the FDA are procedural in nature. Aurobindo Pharma reassured stakeholders that it would address these observations within the stipulated time frame.

This development follows a recent inspection of Aurobindo Pharma's newly-operational injectable facility in Andhra Pradesh, where the US FDA issued three observations. Despite these regulatory challenges, Aurobindo Pharma remains committed to upholding quality standards and ensuring compliance with regulatory requirements.

On the stock market front, shares of Aurobindo Pharma experienced a slight decline of 0.8% on Friday, May 3. However, the company's stock has shown positive performance, with a 6.19% increase in 2024 so far and an impressive 87.27% growth over the past year.

While regulatory inspections and observations are routine in the pharmaceutical industry, Aurobindo Pharma's proactive approach in addressing these issues reflects its commitment to maintaining quality standards and fostering trust among stakeholders. As the company continues to navigate regulatory processes, investors can expect Aurobindo Pharma to prioritize transparency and compliance to ensure the safety and efficacy of its products.

Tags : #

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

MAGGI Empowers 10 Women to Bring their Entrepreneurial dreams to lifeJune 13, 2024
FTCCI announced its Annual Excellence Awards and invites entries, last date is 20th June 2024June 13, 2024
Bird Flu Cases by Dr Praveen Gupta, Principle Director and Chief of Neurology, Fortis Hospital.June 13, 2024
Sova Health's $1 Million Seed Funding to Drive Gut Health InnovationJune 13, 2024
The Vital Role of Early Detection: Kevin Jonas on Battling Skin CancerJune 13, 2024
Zumutor Biologics Advances Cancer Care with Novel Immunotherapy ZM008: A First-in-Class Anti LLT1 AntibodyJune 13, 2024
HP Ghosh Hospital Unveils Innovative "Chest Tree" June 12, 2024
Olympus Enhances Innovation Capabilities by Expanding R&D to Hyderabad, IndiaJune 12, 2024
From the frontlines: Homeless person won over alcoholism, survived floods and defeated TBJune 12, 2024
The Role of Hormones in Obesity: Why Men and Women Gain Weight DifferentlyJune 12, 2024
Silent Killer: How a Young Mother’s Vision Loss Led to a Lung Cancer DiagnosisJune 12, 2024
TruAlt Bioenergy’s subsidiary, Leafiniti Bioenergy supplies over 1000 tons of Compressed Biogas to AG&P Pratham in just 5 monthsJune 11, 2024
Southeast Asia's Most Advanced Luxury Postpartum Centre Re'Joy Suites Opens in SingaporeJune 11, 2024
Poor Muscle Health in Obesity Can be A Major Risk Factor for Early DeathJune 11, 2024
Machine Learning Uncovers How Organ Ageing Impacts Health and LongevityJune 11, 2024
Why Education is Essential for Health and LongevityJune 11, 2024
New Study Reveals Antidepressant Withdrawal Symptoms Less Common but Still SignificantJune 10, 2024
Why Lowering Salt Intake Might Help Your Skin: Key Findings from UCSF StudyJune 10, 2024
Exploring AI's Potential: I&B Ministry's Seminar on Jobs and Healthcare AdvancementsJune 10, 2024
Deeply saddened by the passing away of Sri Ramoji Rao GaruJune 08, 2024