Last Updated on December 22, 2024 by The Health Master
USFDA
Aurobindo Pharma Ltd., a leading manufacturer of generic pharmaceuticals and active pharmaceutical ingredients (APIs), recently announced the results of a US Food and Drug Administration (USFDA) inspection at its new injectable facility in Andhra Pradesh, India.
Successful USFDA Inspection for New Injectable Facility
Eugia Steriles Facility Undergoes Inspection: The inspection, conducted from March 28th to April 5th, 2024, focused on the recently operational injectable facility of Eugia Steriles, a wholly-owned subsidiary of Eugia Pharma Specialties and a step-down subsidiary of Aurobindo Pharma.
This facility is located in Parawada Mandal, Anakapalli District, Andhra Pradesh.
Three Procedural Observations Issued: The USFDA concluded the inspection with three observations. According to a company press release, these observations are procedural in nature, and Aurobindo Pharma will address them within the stipulated timeframe.
Addressing Procedural Observations
While the USFDA observations require a timely response, they are not a cause for major concern. Procedural observations typically focus on documentation, record-keeping, or other non-manufacturing processes.
Aurobindo Pharma’s experience in dealing with regulatory inspections positions them well to effectively address these observations.
Incident at Apitoria Pharmas Unit 6
In a separate announcement, Aurobindo Pharma informed the public about a recent accident at their Apitoria Pharmas Unit 6, also located in Parawada, Anakapalli District.
The company deeply regrets to inform that the accident resulted in the loss of one life. Aurobindo Pharma did not disclose the cause of the accident but expressed their condolences to the victim’s family and assured a thorough investigation into the incident.
About Aurobindo Pharma
Aurobindo Pharma Ltd. is a multinational pharmaceutical company headquartered in Hyderabad, India.
The company is a leading player in the generic pharmaceuticals market, offering a wide range of APIs and finished dosage formulations across various therapeutic segments.
Their commitment to quality and regulatory compliance makes them a trusted partner for healthcare providers and patients worldwide.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
USFDA issued Form 483 with 6 observations to Cipla
USFDA grants VAI classification to Granules India
USFDA issued Form 483 with 4 observations to Alembic Pharma
USFDA issues EIR to Torrent Pharma for Gujarat Plant
CDSCO Approval granted for Early Cancer Detection Test
DTAB: Pain Relief Combo Faces New Ban Recommendation
Chemists Association approaches Govt on Discount Pharmacies: Kerala
DCA Telangana Cracks Down on Drug Manufacturing License Forgery
Compounding Of Offence Under Jan Vishwas Act
USFDA issued Form 483 with 6 observations to Cipla
USFDA grants VAI classification to Granules India
DTAB: Study required to substitute the Prescriptions at Jan Aushadhi Stores
DCC: All states to provide data on Vaccine
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:
