Moneycontrol
Dec 05, 2017 04:56 PM IST | Source: Moneycontrol.com

Shilpa Medicare gets 10 observations from USFDA for its formulation plant in Telangana

The company said out of 10 observations, seven were related to improvement in procedures and practices, while the three others were regarding analytical specifications, test procedures and method validation.

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

Shilpa Medicare on Tuesday informed stock exchanges that it received 10 Form 483 observations from US FDA for its SEZ formulation facility at Jadcherla, near Hyderabad.

The company said out of 10 observations, seven were related to improvement in procedures and practices, while three others were regarding analytical specifications, test procedures and method validation.

US FDA 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.

The Jadcherla unit was planned for carrying out contract manufacturing and dosage developments.

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.

Shares of Shilpa gained 0.67 percent to close at Rs 640.90 on BSE, while the benchmark Sensex declined 0.20 percent to end at 32,802.44 points.
Sections
Follow us on
Available On