Shilpa Medicare has informed that the Company has received an approval from the United States Food & Drug Administration (USFDA) (the Office of Bioequivalence) for Capecitabine Tablets USP, 150 mg and 500 mg to be bioequivalent and therapeutically equivalent to the reference listed drug product (RLD), Xeloda Tablets, 150 mg and 500 mg of Hoffmann-La Roche, Inc.
The above information is a part of company’s filings submitted to BSE.