Glenmark Pharma gains on final USFDA nod on diltiazem hydrochloride capsules

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Glenmark Pharmaceuticals rose 1.10% to Rs 465 after the company received final approval from the US drug regulator for diltiazem hydrochloride extended‐release capsules.

The product is the generic version of Cardizem SR extended‐release capsules, 60 mg, 90 mg, and 120 mg, of Biovail Laboratories Inc. The drug is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.

Glenmark Pharmaceuticals has been granted a competitive generic therapy (CGT) designation for diltiazem hydrochloride extended‐release capsules USP, 60 mg, 90 mg, and 120 mg, therefore, with this approval, the pharmaceutical major has become the first approved applicant for such competitive generic therapy and is eligible for 180 days of CGT exclusivity upon commercial marketing.

According to IQVIA figures, the sales data for the 12-month period ending January 2021, the Cardizem SR Extended‐Release capsules, 60 mg, 90 mg, and 120 mg market2 achieved annual sales of approximately $56.7 million.

Glenmark Pharmaceuticals’ current portfolio consists of 170 products authorized for distribution in the U.S. marketplace and 42 ANDA’s pending approval with the United States Food and Drug Administration (USFDA). In addition to these internal filings, Glenmark Pharmaceuticals continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

The announcement was made before market hours today, 23 March 2021. Yesterday, Glenmark Specialty S.A. in Switzerland and an affiliate of Bausch Health Companies Inc. had entered into an exclusive licensing agreement for the commercialization of Glenmark Pharma.’s innovative nasal spray Ryaltris, under review by Health Canada.

Glenmark Pharma’s consolidated net profit jumped 30% to Rs 248.18 crore on 4.6% increase in net sales to Rs 2,758.74 crore in Q3 December 2020 over Q3 December 2019.

Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across generics, specialty and over-the-counter (OTC) business with operations in over 50 countries. Glenmark’s key therapy focus areas globally are respiratory, dermatology and oncology.

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