Moneycontrol
Dec 06, 2017 09:34 AM IST | Source: Moneycontrol.com

Shilpa Medicare declines 6% as USFDA issues 10 observations for Telangana facility

The company has received 483 observations from the United States Food & Drug Administration (USFDA) in relation to SEZ formulation facilities situated at Jadcherla, Telangana (near Hyderabad).

Moneycontrol News @moneycontrolcom
 
 
live
  • bselive
  • nselive
Volume
Todays L/H
More

Shares of Shilpa Medicare declined nearly 6 percent intraday Wednesday as it has received 10 observations from USFDA.

The company has received 483 observations from the United States Food & Drug Administration (USFDA) in relation to SEZ formulation facilities situated at Jadcherla, Telangana (near Hyderabad).

The company has received total 10 observations, which includes 7 observations for improvement in procedures and practices and 3 observations are related to setting of analytical specifications, test procedures and method validation.

USFDA communicates any deviations in manufacturing practices observed during the inspection on Form 483. Typically, the company needs to respond to USFDA within a period of 15 days with a corrective action plan.

Shilpa has been engaged in the manufacture of active pharmaceutical ingredients (APIs) since 1987; overtime the company shifted its focus to formulation targeting regulated markets.

At 09:25 hrs Shilpa Medicare was quoting at Rs 612.05, down Rs 23.10, or 3.64 percent on the BSE.

Posted by Rakesh Patil
Sections
Follow us on
Available On