Last Updated on October 15, 2024 by The Health Master
USFDA Inspection
In a significant development for the Indian pharmaceutical industry, Alembic Pharmaceuticals Limited (Alembic Pharma) has successfully completed a US Food and Drug Administration (USFDA) inspection of its Oncology (Injectable and Oral Solid) Formulation Facility (F-2) located at Panelav, Gujarat.
The company recently announced receiving the Establishment Inspection Report (EIR) from the USFDA, signifying a crucial step towards expanding its reach in the high-growth oncology generics market.
US FDA Inspection Concludes with Minor Observations
The through USFDA inspection was conducted of the Panelav facility from February 28th to March 8th, 2024.
The USFDA inspection resulted in an EIR with four procedural observations, indicating a high level of compliance with USFDA manufacturing standards for oncology drugs.
Alembic Pharma is confident in its ability to address these minor observations swiftly.
Alembic Pharma Now Holds EIRs for All USFDA-Regulated Facilities
This positive EIR from the USFDA strengthens Alembic Pharma’s position as a leading manufacturer of high-quality generics for the US market.
“With this, for all our USFDA facilities, EIRs are in place,” stated the company in a BSE filing.
This achievement demonstrates Alembic Pharma’s unwavering commitment to meeting the most stringent regulatory requirements for pharmaceutical manufacturing.
About Alembic Pharmaceuticals Limited
Established in 1907 and headquartered in Vadodara, Gujarat, Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India with a strong presence in the international generics market.
The company boasts a vertically integrated business model, encompassing the manufacturing and marketing of India Formulations, International Generics, and Active Pharmaceutical Ingredients (APIs).
Alembic Pharma’s state-of-the-art research and manufacturing facilities have earned approvals from regulatory authorities in numerous developed countries, including the prestigious USFDA.
Key Takeaways:
- Alembic Pharma receives a positive EIR from the USFDA for its Oncology Formulation Facility (F-2) at Panelav.
- The USFDA inspection identified only minor procedural observations.
- Alembic Pharma now holds EIRs for all its USFDA-regulated facilities, solidifying its position as a top-tier generics manufacturer.
- This achievement paves the way for Alembic Pharma to expand its offerings in the high-growth oncology generics market.
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.
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