USFDA issues Form 483 with 5 observations to Torrent

The Form 483 issued to Torrent Pharma listed five procedural observations.

December 13, 2023

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Last Updated on October 2, 2024 by The Health Master

Form 483

The United States Food and Drug Administration (USFDA) recently concluded a pre-approval inspection (PAI) at Torrent Pharma‘s oral-oncology manufacturing facility in Bileshwarpura, Gujarat.

This article delves into the details of the inspection, focusing on the Form 483 issued by the USFDA, procedural observations, and Torrent Pharma’s response.

In the complex landscape of pharmaceuticals, the USFDA’s Form 483 holds a crucial role. It is a notice issued to a company at the end of an inspection, highlighting any conditions that may constitute violations of the Food, Drug, and Cosmetic (FD&C) Act and related laws.

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Torrent Pharma’s Oral-Oncology Facility Inspection

The oral-oncology manufacturing facility in Gujarat underwent scrutiny from December 5 to December 11. This timeframe signifies the intensity and thoroughness of the USFDA’s assessment of Torrent Pharma’s operations.

Procedural Observations in Form 483

The Form 483 issued to Torrent Pharma listed five procedural observations. It is noteworthy that there were no observations related to data integrity, a critical aspect in the pharmaceutical industry.

USFDA’s Pre-Approval Inspection (PAI)

The PAI conducted by the USFDA plays a pivotal role in evaluating the manufacturing process before approving new drugs. Understanding the purpose and implications of this inspection provides context to Torrent Pharma‘s recent experience.

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Response from Torrent Pharma

Torrent Pharma promptly responded to the Form 483, expressing its commitment to addressing the observations within the specified timeframe. The proactive approach is crucial in maintaining regulatory compliance.

Collaboration with USFDA

Collaboration with regulatory bodies is paramount for pharmaceutical companies. Torrent Pharma’s commitment to working closely with the USFDA underscores the industry’s dedication to quality and safety standards.

Previous USFDA Inspection at Dahej Manufacturing Facility

This incident follows the USFDA’s inspection at Torrent Pharma‘s Dahej manufacturing facility in May, which resulted in an ‘Official Action Indicated (OAI)’ classification. The subsequent closure of the inspection in August signifies the company’s responsiveness to regulatory concerns.

Financial Performance

On a positive note, Torrent Pharma reported a remarkable 23.7% year-on-year surge in net profit, reaching ₹386 crore for the second quarter ending September 30, 2023. The total revenue also witnessed a substantial jump of 16.1%, standing at ₹2,660 crore.

Stock Market Response

Despite the Form 483 observations, Torrent Pharma‘s shares demonstrated resilience, trading 0.17% up at Rs 2,081.80 apiece at 11.30 am. This indicates the market’s confidence in the company’s ability to address and resolve the procedural observations.

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.

FAQs

Q: What is the significance of the USFDA’s Form 483 in the pharmaceutical industry?
- A: The Form 483 serves as a crucial notice, highlighting potential violations of the FD&C Act and related laws after a regulatory inspection.
Q: Why is data integrity important in pharmaceutical manufacturing?
- A: Data integrity ensures the accuracy and reliability of information, playing a vital role in maintaining the quality and safety of pharmaceutical products.
Q: How does a pre-approval inspection (PAI) contribute to drug approval?
- A: The PAI evaluates the manufacturing process before approving new drugs, ensuring compliance with regulatory standards.
Q: What does ‘Official Action Indicated (OAI)’ classification mean in a USFDA inspection?
- A: OAI indicates that significant regulatory violations were observed during an inspection, requiring prompt corrective action.
Q: How did the stock market respond to Torrent Pharma’s Form 483 observations?
- A: Despite the observations, Torrent Pharma’s shares showed resilience, trading slightly up, indicating market confidence in the company’s ability to address the concerns.