Shilpa Medicare gets USFDA approval for Imatinib Mesylate Tablets

Imatinib Mesylate is a generic equivalent of the reference-listed drug (RLD) Gleevec (100mg and 400mg), which is used in the treatment of leukaemia as recommended in the label approved by FDA.

New Delhi: Shilpa Medicare has recently received US Food and Drug Administration (USFDA) approval for its ANDA, Imatinib Mesylate Tablets, 100 mg and 400 mg.

Imatinib Mesylate is a generic equivalent of the reference-listed drug (RLD) Gleevec (100mg and 400mg), which is used in the treatment of leukaemia as recommended in the label approved by FDA.

As per IQVIA MAT Q2 2018 data, the US market for Imatinib Mesylate Tablets is approximately USD 885 million.

Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989.

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