Last Updated on October 15, 2024 by The Health Master
USFDA Inspection
USFDA Inspection: Aurobindo Pharma recently made a significant announcement that has reverberated through the pharmaceutical industry.
The United States Food and Drug Administration (USFDA) concluded its Pre-Approval Inspection (PAI) at the Unit-I & III, Formulation manufacturing facility of APL Healthcare Ltd., a wholly-owned subsidiary of Aurobindo Pharma, located in Telangana, India.
Details of the Inspection
The inspection, conducted from November 13 to 17, 2023, resulted in an exceptional outcome for Aurobindo Pharma—zero observations and a classification of “No Action Indicated” (NAI).
This classification implies that no objectionable conditions or practices were identified during the inspection, highlighting Aurobindo Pharma’s commitment to maintaining high standards in pharmaceutical manufacturing.
Significance of Zero Observations
The closure of the inspection with zero observations holds immense significance for Aurobindo Pharma.
It not only reinforces the company’s commitment to quality but also sets a benchmark for industry best practices.
This achievement reflects positively on Aurobindo Pharma’s reputation in the pharmaceutical sector.
Aurobindo Pharma Limited
Headquartered in Hyderabad, India, Aurobindo Pharma Limited has emerged as a key player in the pharmaceutical industry.
The company is involved in the development, manufacturing, and distribution of generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients.
Manufacturing Facilities and Global Approvals
Aurobindo Pharma’s manufacturing facilities, including APL Healthcare Ltd., have received approvals from renowned regulatory agencies such as the USFDA, UK MHRA, EU, Japan PMDA, WHO, Health Canada, South Africa MCC, and Brazil ANVISA.
This extensive recognition underscores the company’s dedication to adhering to global quality standards.
USFDA Approval and Global Recognition
Aurobindo Pharma’s standing with the USFDA is a testament to its adherence to stringent regulatory standards.
Additionally, the company’s recognition by other regulatory bodies further solidifies its position as a reliable and compliant pharmaceutical manufacturer.
Hyderabad: A Hub for Pharmaceutical Innovation
Aurobindo Pharma’s presence in Hyderabad has not only contributed to the region’s economic growth but has also played a crucial role in providing employment opportunities.
The company’s commitment to excellence has positioned Hyderabad as a hub for pharmaceutical innovation.
USFDA issues Form 483 with 10 observations to Dr Reddy’s Lab
USFDA issues EIR For Piramal Pharma Bethlehem Facility
USFDA issues Form 483 with 9 observations to Panacea: Baddi
USFDA issues Form 483 with 9 observation to Dr Reddy’s laboratories: Hyderabad
USFDA issued EIR to InvaGen Pharma of Cipla
USFDA issues Form 483 with one observation to Aurobindo Unit IV: Andhra Pradesh
Integrating Life-Saving Medical Devices at Cricket Matches
USFDA issues warning letter to Amazon regarding Eye Drops: Read detail
CDSCO Guidelines on Drug Recall
The Implications of the National Pharmacy Commission Bill, 2023
USFDA approval granted for the drug for Kidney Disease Treatment
The Game-Changing Migraine management Device: Journey to Approval in India
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
