Piramal Pharma slips as US FDA issues Form 483 with six observations

Image
Capital Market
Last Updated : Jan 11 2023 | 1:31 PM IST

Piramal Pharma declined 1.30% to Rs 117.45 after the pharma company said that the United States Food and Drug Administration (USFDA) issued a Form 483, with six observations after the inspection of its Lexington facility.

The USFDA conducted a pre-approval inspection (PAI) and good manufacturing practices (GMP) inspection of Piramal Pharma's Lexington facility, Kentucky, USA from 27 December 2022 to 10 January 2023.

The observations were classified under voluntary action indicated (VAI) and does not relate to data integrity, the company said.

The company added that it is preparing a detailed response to the observations, which will be submitted to the US FDA within the stipulated timelines.

Piramal Pharma lastly added that it remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations.

Piramal Pharma is a pharmaceutical company that manufactures and develops a wide range of pharmaceutical solutions to reduce diseases. Piramal Pharma serves customers worldwide.

The company reported a net loss of Rs 37.34 crore in Q2 FY23 as against a net profit of Rs 36.56 crore in Q2 FY22. Net Sales rose 9% YoY to Rs 1,720.01 crore in the quarter ended 30 September 2022.

Powered by Capital Market - Live News

Disclaimer: No Business Standard Journalist was involved in creation of this content

Subscribe to Business Standard digital and get complimentary access to The New York Times

Quarterly Starter

₹900

3 Months

₹300/Month

SAVE 25%

Smart Essential

₹2,700

1 Year

₹225/Month

Save 46%

Super Saver

₹3,900

2 Years

₹162/Month

Subscribe

Renews automatically, cancel anytime

Here’s what’s included in our digital subscription plans

Access to Exclusive Premium Stories Online

  • Over 30 behind the paywall stories daily, handpicked by our editors for subscribers

Complimentary Access to The New York Times

  • News, Games, Cooking, Audio, Wirecutter & The Athletic

Business Standard Epaper

  • Digital replica of our daily newspaper — with options to read, save, and share

Curated Newsletters

  • Insights on markets, finance, politics, tech, and more delivered to your inbox

Market Analysis & Investment Insights

  • In-depth market analysis & insights with access to The Smart Investor

Archives

  • Repository of articles and publications dating back to 1997

Ad-free Reading

  • Uninterrupted reading experience with no advertisements

Seamless Access Across All Devices

  • Access Business Standard across devices — mobile, tablet, or PC, via web or app

More From This Section

First Published: Jan 11 2023 | 1:09 PM IST

Next Story