Shilpa Medicare’s Jadcherla facility completes USFDA audit
New Delhi: Drug firm Shilpa Medicare on Tuesday said its Jadcherla formulations facility near Hyderabad has been inspected by the US health regulator with no adverse reactions.
The company had an audit conducted by the United States Food & Drug Administration (USFDA) at the SEZ formulations facility situated at Jadcherla, near Hyderabad, from July 18, 2016 to July 26, 2016, Shilpa Medicare said in a filing to BSE.
The company has not received Form 483 for the above mentioned facility, it added.
An FDA Form 483 is issued to the management of a firm at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Shares of Shilpa Medicare today closed 4.40 per cent up at Rs 585.10 ascrip on BSE.
PTI
