Glenmark's diltiazem capsules

USFDA approves Glenmark’s diltiazem capsules

Glenmark gets first applicant approval for its diltiazem hydrochloride capsules from USFDA :

Glenmark Pharma recently announced its diltiazem hydrochloride’s approval for extended–release capsules by USFDA, as per the reports made public on 23 March 2021 [1].  Read the story behind Glenmark’s diltiazem capsules.

The product is the generic version of Cardizem SR[1] extended–release capsules, 60 mg, 90 mg, and 120 mg. Biovail Laboratories Inc. manufactures this drug product. It is indicated for the treatment of hypertension. For therapeutic purposes, it can be either used alone or in combination with other antihypertensive medications. Read about Diltiazem- Indications, Dosage, Contraindications, ADRs

The pharma major has been granted a competitive generic therapy ( CGT ) designation for this product. The CGT has made this generic version the first approved applicant for such competitive generic therapy. With this designation, the pharma company is eligible for 180 days of CGT exclusivity upon its commercial marketing.

Glenmark’s diltiazem capsules Story background:

As per IQVIA[2] figures, the sales data for the 12 months ending in January 2021 was approximately $ 56.7 million. This data corresponds to the sales data of Cardizem SR extended–release capsules, 60 mg, 90 mg, and 120 mg. Read more about IQVIA- The Human Data Science Company

Glenmark Speciality S.A. in Switzerland has also made an exclusive licensing agreement with an affiliate of Bausch Health Companies, Inc. The agreement was made on 22 March 2021 to commercialize Glenmark’s innovative nasal spray Ryaltris. Ryaltris is currently under review by Health Canada. Glenmark Pharma: Popular Brands, Composition, And Pack Details

Glenmark operates in over 50 countries and is a global research–oriented pharma company. Respiratory, dermatology, and oncology are some of the key focus areas of this pharma major. Read more The Scope and Importance of Clinical Research in the Pharma Industry


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