USFDA issued Positive EIR to Gland Pharma: Hyderabad

The inspection, conducted between, culminated in the issuance of the positive EIR, signifying the successful closure of the inspection process.

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USFDA Inspection audit
USFDA Inspection

Last Updated on December 31, 2023 by The Health Master

Positive EIR

Shares of Gland Pharma, a prominent player in the pharmaceutical industry, experienced a positive upswing, surging by 2 percent, following the reception of a positive EIR (Establishment Inspection Report) from the US Food and Drug Administration (USFDA) for its Pashamylaram facility in Hyderabad.

This report comes as a testament to Gland Pharma’s commitment to maintaining stringent regulatory standards.

The inspection, conducted between June 15th and June 27th, 2023, culminated in the issuance of the positive EIR, signifying the successful closure of the inspection process.

Inspection Overview:

The inspection primarily focused on two key aspects:

  1. Pre-Approval of Seven Products:
    • The USFDA undertook a meticulous assessment to pre-approve seven of Gland Pharma’s crucial products. This endorsement stands as a significant milestone for the company, attesting to the quality and compliance of its offerings.
  2. Adherence to Good Manufacturing Practices (GMP):
    • Ensuring adherence to the USFDA’s Good Manufacturing Practices was a pivotal objective of this inspection. This critical evaluation is instrumental in upholding the highest standards of pharmaceutical manufacturing.

Financial Performance:

Despite the recent dip in net profit, with a 15.3 percent year-on-year decrease to Rs. 194.1 crore for the first quarter ending June 30, 2023, Gland Pharma’s proactive approach to regulatory affairs remains a key factor in its long-term success.

The EIR from the USFDA reinforces the company’s dedication to addressing concerns and maintaining impeccable quality standards.

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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