USFDA issues positive EIR to Alembic for Panelav facility

The receipt of a clean EIR from the USFDA is a testament to Alembic Pharma's commitment to excellence in manufacturing and quality control.

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USFDA Inspection
USFDA Inspection

Last Updated on October 7, 2024 by The Health Master

EIR

Alembic Pharma, a leading Indian pharmaceutical company, has achieved a significant milestone with the receipt of a clean Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA).

This positive outcome follows a thorough inspection of the company’s Oral Solid Formulation Facility (F-I) located in Panelav.

USFDA Inspection a Success:

The inspection, conducted from July 17th to 26th, 2024, was a rigorous assessment of the facility’s compliance with USFDA standards.

Alembic Pharma is pleased to announce that the inspection was completed without any Form 483 observations, indicating a successful outcome and adherence to regulatory requirements.

Alembic Pharma’s Commitment to Quality:

Alembic Pharma, a vertically integrated research and development company, is dedicated to providing high-quality generic pharmaceutical products to patients worldwide.

The company’s state-of-the-art manufacturing facilities are subject to stringent quality control measures and are approved by regulatory authorities in numerous countries, including the USFDA.

In conclusion, the receipt of a clean EIR from the USFDA is a testament to Alembic Pharma’s commitment to excellence in manufacturing and quality control.

This achievement reinforces the company’s position as a trusted supplier of generic pharmaceuticals and strengthens its global presence.

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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