Shilpa Medicare has informed that the Company has received US Food and Drug Administration approval for its ANDA, Imatinib Mesylate Tablets, 100 mg and 400 mg on 17.01.2019. Imatinib Mesylate Tablets is a generic equivalent of the reference listed drug (RLD), gleevec Tablets, 100 mg and 400 mg used in the treatment of leukemia as recommended in the label approved by FDA. According to IQVIA MAT Q2 2018 data, the US market for Imatinib Mesylate Tablets, 100 mg and 400 mg is approximately $885 Million.
The above information is a part of company’s filings submitted to BSE.
