Shilpa Medicare Ltd said it received an approval from the United states Food & Drug Administration for Azacitidine injection.
Azacitidine is used to treat myelodysplastic syndrome – a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells.
The approval was received under a Abbreviated New Drug Application or ANDA.
An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug.
Shilpa Medicare Limited was established in 1987.
The company manufactures API ingredients at Raichur Unit, Karnataka.
The company also manufactures Trimethoprim for other companies like Eskayef Limited, Bombay Drugs and Pharmas Limited, Bombay Drug House Ltd., US Vitamins Ltd, Sandoz India Ltd etc. for their export commitments.
