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

Uncovering the Presence of Microplastics in Human Blood and Their Health EffectsMay 18, 2024
Potential Risks of Meftal: What Consumers and Doctors Should KnowMay 18, 2024
Over-the-Counter Medications in India: A New Era of AccessibilityMay 18, 2024
DCGI Acts Against Overcharging: New Regulations for Blood CentresMay 17, 2024
Cattle as Hosts for Human and Bird Flu Viruses: A Potential Public Health ConcernMay 17, 2024
The Ethics of Live Surgery Broadcasts: NMC Seeks Public OpinionMay 17, 2024
Successful Removal of 3.7 KG Large Abdominal Tumor from 14-Year-Old Somalian Girl at KIMS Cuddles HospitalMay 16, 2024
iLEAD Sets a Precedent by Launching a Graphic Anthology Authored by Multimedia, Animation and Graphics Students May 16, 2024
Ramaiah Memorial Hospital Launches Novel Intra-Operative Radiation Therapy (IORT); Achieves significant advancement in Cancer Treatment to Enhance Quality of LifeMay 16, 2024
IIITH Announces Product Management Summer SchoolMay 16, 2024
Çelebi India's Delhi Cargo Terminal Successfully Handles Airbus H125 Helicopter ShipmentMay 16, 2024
Plant-Based Diets and Prostate Cancer: New UCSF Study Shows Promising ResultsMay 16, 2024
National Medical Commission Approves 112 New Medical CollegesMay 16, 2024
Study Suggests That Chemotherapy Results in Physical Decline for Older Women with Breast CancerMay 16, 2024
Google DeepMind's AlphaFold 3: Revolutionizing Drug Discovery with AIMay 16, 2024
Hester Biosciences Ltd reports Consolidated Revenue growth of 18% at Rs. 79.3 crore, EBITDA up 37% to Rs. 16.4 crore and Net Profit up 12% to Rs. 6.40 crore in Q4FY24May 16, 2024
Akshay Tritiya Parna Mahotsav heldMay 16, 2024
IT Minister Sridhar Babu to grace the 10th National Facilities Managers Summit-2024, to be held in the cityMay 15, 2024
Alarming Study Reveals Cancer-Causing Chemicals in Car InteriorsMay 15, 2024
India's Thalassemia Challenge: The Importance of Early Screening and TreatmentMay 15, 2024