Wockhardt gets USFDA’s approval for Imatinib Mesylate tablet

21 Jan 2019 Evaluate

Wockhardt has received approval from the United States Food & Drug Administration (USFDA) for an ANDA for 100 mg and 400 mg tablets of Imatinib Mesylate, which is used to treat many kinds of cancers and tumors. The company’s Imatinib Mesylate tablets are a generic version of Gleevec, marketed in USA and other countries by Novartis.

Imatinib stops the cancer cells from growing and is indicated for treating cancers like Leukemia and some Gastro-Intestinal tumors. According to IMS MAT1118, the product has sales of $707 million in the US.

Wockhardt is one of the few companies with end to end integrated capabilities for its products, starting with the manufacture of the oral and sterile API’s, the dose forms and marketing through wholly owned subsidiary in the US, enabling the company to capture maximum value.

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