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Piramal Pharma Gets US FDA Form 483 after GMP Inspection

Piramal Pharma Gets US FDA Form 483 after GMP Inspection

Synopsis:


Piramal Pharma Limited said the US FDA inspected its Lexington unit from 3 to 10 December 2025. The inspection ended with a Form 483 carrying four observations. The company stated that these relate to procedure updates and are classified as Voluntary Action Indicated.


Source:
Piramal Pharma Limited Press Release (NSE Exchange Filings) | Published on Dec 11, 2025

Disclaimer: This content has been published for informational purposes only. Bajaj Broking is not affiliated with, nor does it endorse or assume any responsibility for, the source material. Readers are advised to consult the original publication for complete and accurate context.

As quoted in the press release from Piramal Pharma Limited and its news (NSE Exchange Filings), the company informed stock exchanges about a US FDA inspection at its Lexington facility in Kentucky, United States. The inspection was a general Good Manufacturing Practices review. It started on 3 December 2025 and ended on 10 December 2025. The disclosure was made under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

The filing confirms that the inspection covered routine GMP compliance at the manufacturing site.

Also read: Infosys Completes Share Buyback, Extinguishes 10 Crore Shares

PIRAMAL PHARMA LIMITED

Trade

1720.21 (0.12 %)

Updated - 12 December 2025
174.59day high
DAY HIGH
170.65day low
DAY LOW
2183518
VOLUME (BSE)

Key Takeaways

  • The US FDA inspected the Lexington facility from 3 to 10 December 2025

  • The inspection ended with a Form 483 containing four observations.

  • The deficiencies cited may be rectified through improved procedures

  • It is classified as Voluntary Action Indicated

Form 483 Observations

At the end of the inspection, the US FDA issued a Form 483.The form listed four observations.

The company stated that these observations relate to enhancements in procedures followed at the facility. The classification of the observations was stated as Voluntary Action Indicated.

The update reports the inspection outcome as recorded at the close of the review.

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Regulatory Filing Details

The disclosure states that Piramal Pharma Limited is preparing a detailed response to the observations. The response will be submitted to the US FDA within the required timelines. The filing records confirmed the information available at the end of the inspection. It does not include forecasts, assumptions, or outcomes beyond the stated facts.

Such disclosures form part of routine regulatory reporting for overseas inspections.

Inspection Summary

Particular

Details

Company

Piramal Pharma Limited

Facility

Lexington, Kentucky, USA

Regulator

US Food and Drug Administration

Inspection Type

General GMP Inspection

Inspection Dates

3–10 December 2025

Observations

Four

Classification

Voluntary Action Indicated

Piramal Pharma Share Price Update

Piramal Pharma share price data showed movement on the day of the disclosure. As per NSE data on 11 December 2025 at 15:30 PM IST, the Piramal Pharma share price stood at ₹172.10.

The stock gained ₹1.11, or 0.65%, during the session. It opened at ₹170.90 and touched an intraday high of ₹173.62. The day’s low was ₹169.58.

The previous close was ₹170.99. The volume weighted average price for the session stood at ₹171.74.

Also read: Rama Steel Tubes To Acquire UAE-Based Automech Group

Published Date : 12 Dec 2025

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