New Delhi : Shilpa Medicare said it has received US health regulator’s nod to sell Azacitidine injection, used in treatment of myelodysplastic syndrome, in the US market.
“The company has received an approval from the United States Food & Drug Administration (USFDA) for Azacitidine Injection ANDA of SEZ formulations facility situated at Jadcherla, near Hyderabad,” Shilpa Medicare said in a BSE filing.
Myelodysplastic syndrome is a condition that affects the bone marrow and the blood cells it produces.
In July this year, Shilpa Medicare said its Jadcherla formulations facility near Hyderabad has been inspected by the US health regulator with no adverse reactions.
The company has not received Form 483 for the above mentioned facility, it added.
FDA Form 483 is issued to the management of a firm after 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 were trading 2.85 per cent up at Rs 617.95 on BSE.