Alkem Laboratories update on USFDA inspection of its facility in St. Louis, USA

Image
Capital Market
Last Updated : Mar 22 2019 | 4:04 PM IST
Alkem Laboratories announced that with reference to the USFDA inspection of its facility at St. Louis, USA, the company had submitted a detailed response to the eight (8) Form 483 observations that it had received during a pre-approval inspection for a product at the Company's manufacturing facility located at St. Louis, USA.

The Company has now received a letter from the USFDA informing that the manufacturing of the said product be withheld until the completion of the final evaluation by the USFDA and the final decision of the USFDA shall be communicated to the Company accordingly. It is to be noted that the said product is not being manufactured at this time as it is awaiting approval from US FDA.

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

Smart Quarterly

₹900

3 Months

₹300/Month

SAVE 25%

Smart Essential

₹2,700

1 Year

₹225/Month

SAVE 46%
*Complimentary New York Times access for the 2nd year will be given after 12 months

Super Saver

₹3,900

2 Years

₹162/Month

Subscribe

Renews automatically, cancel anytime

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

Exclusive premium stories online

  • Over 30 premium stories daily, handpicked by our editors

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: Mar 22 2019 | 3:26 PM IST

Next Story