Last Updated on October 12, 2024 by The Health Master
USFDA Inspection
Aurobindo Pharma Ltd., a leading Indian pharmaceutical company, recently announced a successful US Food and Drug Administration inspection (USFDA inspection) at one of its subsidiary’s facilities.
The USFDA inspection, conducted at Unit-II of Eugia Pharma Specialities Ltd. in Bhiwadi, Rajasthan, concluded with only seven observations.
Inspection Details and Findings
- Facility: Unit-II, Eugia Pharma Specialities Ltd. (a wholly-owned subsidiary of Aurobindo Pharma)
- Location: Bhiwadi, Alwar, Rajasthan, India
- Date of Inspection: April 25th to May 3rd, 2024
- Observations: 7 (reported as procedural in nature)
Company Response
Aurobindo Pharma has assured investors and stakeholders that the company will address these observations within the stipulated timeframe.
The company emphasized that the observations are procedural, indicating no major concerns regarding manufacturing practices.
About Aurobindo Pharma
Aurobindo Pharma Ltd. is a prominent player in the global pharmaceutical industry, headquartered in Hyderabad, India.
The company boasts a comprehensive portfolio encompassing:
- Generic Pharmaceuticals: Offering a wide range of generic drugs across various therapeutic areas.
- Branded Specialty Pharmaceuticals: Developing and marketing specialty drugs under its own brand names.
- Active Pharmaceutical Ingredients (APIs): Manufacturing the essential ingredients used in drug production.
Global Reach and Recognition
Aurobindo Pharma operates across more than 150 countries, with a robust network of 25 manufacturing and packaging facilities.
These facilities are recognized and approved by leading regulatory agencies worldwide, including:
- USFDA (United States Food and Drug Administration)
- UK MHRA (Medicines and Healthcare products Regulatory Agency)
- EDQM (European Directorate for the Quality of Medicines & Healthcare)
- Japan PMDA (Pharmaceuticals and Medical Devices Agency)
- WHO (World Health Organization)
- Health Canada
- South Africa MCC (Medicines Control Council)
- Brazil ANVISA (National Health Surveillance Agency)
Strong Product Portfolio and R&D Focus
Aurobindo Pharma caters to a diverse range of therapeutic needs with its product portfolio, spanning seven major areas:
- CNS (Central Nervous System)
- AntiRetroviral (HIV/AIDS treatment)
- CVS (Cardiovascular System)
- Antibiotics
- Gastroenterological
- Anti-Diabetics
- Anti-Allergic
The company further strengthens its position through a dedicated Research and Development (R&D) setup, ensuring continuous innovation and product development.
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 inspection: With OAI observations at Sun Pharma
USFDA Inspection: Natco Pharma Receives Positive EIR
USFDA Inspection: At Zydus Lifesciences with 10 observations
Lupin Receives EIR from USFDA for its Aurangabad Facility
USFDA Inspection: At Marksans with 5 inspectional observations
Pharmac South 2024 Gears Up for Special Conference on Revised Schedule M
New Ceiling Prices Announced for Coronary Stents in India
CDSCO-WHO Launches Virtual Webinar Series for Indian Regulators
Drug Export NOCs Now Handled by CDSCO
USFDA Approval granted for Acetaminophen and Ibuprofen Tablets
Drug recall: This Dietary Supplement recalled due to the Presence of Nortadalafil
DCA Telangana raids crack down on Mislabeled Medicines
Is the Drugs and Magic Remedies Act Outdated ?
USFDA approval granted for Loteprednol Etabonate Eye Drops
Proposed Sale of OTC Drugs in General Stores Raises Concerns from Chemists
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: