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Glenmark rises on receiving USFDA approval for Bendamustine Hydrochloride for Injection

Glenmark Pharmaceuticals Ltd. | Pharmaceuticals & Drugs | Healthcare | BSE: 532296 | NSE: GLENMARK

28 Mar 2016 Evaluate

Glenmark Pharmaceuticals is currently trading at Rs. 827.00, up by 4.90 points or 0.60% from its previous closing of Rs. 822.10 on the BSE.

The scrip opened at Rs. 839.75 and has touched a high and low of Rs. 839.75 and Rs. 825.00 respectively. So far 2,511 shares were traded on the counter.

The BSE group 'A' stock of face value Rs. 1 has touched a 52 week high of Rs. 1261.95 on 21-Aug-2015 and a 52 week low of Rs. 671.50 on 12-Feb-2016.

Last one week high and low of the scrip stood at Rs. 839.75 and Rs. 778.35 respectively. The current market cap of the company is Rs. 23,386.00 crore.

The promoters holding in the company stood at 46.47% while Institutions and Non-Institutions held 42.50% and 11.02% respectively.

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Bendamustine Hydrochloride for Injection, 25 mg/vial and 100 mg/vial, the therapeutic equivalent to the reference listed drug product, Treanda for Injection, 25 mg/vial and 100 mg/vial, of Cephalon, Inc. This marks Glenmark’s first injectable granted approval by the USFDA.

Under the terms of the prior settlement agreement, Glenmark will be able to launch its product on November 1, 2019, or earlier under certain circumstances. Glenmark was one of the first ANDA applicants to submit a substantially complete ANDA with a Paragraph IV certification, therefore, Glenmark may be eligible for 180 days of marketing exclusivity for Bendamustine Hydrochloride for Injection, 25 mg/vial and 100 mg/vial.

According to IMS Health sales data for the 12 month period ending January 2016, the Treanda for Injection, 25 mg/vial and 100 mg/vial Market achieved annual sales of approximately $92.6 million.

Glenmark’s current portfolio consists of 110 products authorized for distribution in the US marketplace and 59 ANDA’s pending approval with the USFDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

Glenmark Pharma Share Price

2247.90 -1.65 (-0.07%)

17-Apr-2026 16:59 View Price Chart

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Glenmark rises on receiving USFDA approval for Bendamustine Hydrochloride for Injection

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