USFDA Inspection: At Aurobindo Pharma Arm with 7 USFDA Observations

Last Updated on December 22, 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:

1. CNS (Central Nervous System)
2. AntiRetroviral (HIV/AIDS treatment)
3. CVS (Cardiovascular System)
4. Antibiotics
5. Gastroenterological
6. Anti-Diabetics
7. 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.

For informative videos by The Health Master, click on the below YouTube icon:

• Key Notes on Revised Schedule M: Point No. 14 – Materials
  December 25, 2024
• USFDA issues VAI status to Biocon for Bengaluru API facility
  December 25, 2024
• Bulk drug import from China continues to rise in 5 years
  December 25, 2024
• High Court stays action against Pharma Units manufacturing Nutraceuticals
  December 25, 2024
• NPPA fixed retail price of 7 formulations: December 2024
  December 24, 2024
• Revised Schedule M: Industry seeks balance between Quality and Viability
  December 24, 2024

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: