Glenmark Pharmaceuticals shines on USFDA approval

DSIJ Intelligence / 19 Apr 2017

Glenmark Pharmaceuticals shines on USFDA approval

Glenmark Pharmaceuticals has been granted tentative approval by the United States Food & Drug Administration (US FDA) for Dabigatran Etexilate Capsules, 75 mg, 110 mg and 150 mg.

Glenmark Pharmaceuticals has been granted tentative approval by the United States Food & Drug Administration (US FDA) for Dabigatran Etexilate Capsules, 75 mg, 110 mg and 150 mg. The company’s approved drugs are generic versions of Pradaxa Capsules, 75 mg, 110 mg and 150 mg of Boehringer Ingelheim Pharmaceuticals, Inc.

According to IMS Health sales data for the 12-month period ending February 2017, the Pradaxa Capsules has achieved annual sales of approximately USD 913 million (Rs 5896 crore).

Glenmark’s current portfolio consists of 114 products authorized for distribution in the US marketplace and 65 ANDA’s pending approval with the USFDA. In addition to these internal filings, the company continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

On financial front, Glenmark’s revenue increased 42.55 per cent to Rs 2535 crore in Q3FY17 on yearly basis. The company’s net profit also boosted more than two times to Rs 477 crore in Q3FY17 as compared to same period in previous fiscal year.

The share price of Glenmark Pharmaceuticals increased 0.64 per cent in an early trade and is trading at Rs 898 in an intraday basis.

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