Glenmark Pharma gets USFDA nod for Diltiazem Hydrochloride ER Capsules
Mumbai: Drug major, Glenmark Pharmaceuticals Limited, today announced that the company has received final approval by the United States Food & Drug Administration (USFDA) for Diltiazem Hydrochloride Extended‐Release Capsules USP, 60 mg, 90 mg, and 120 mg.
The product is the generic version of Cardizem SR Extended‐Release Capsules, 60 mg, 90 mg, and 120 mg, of Biovail Laboratories Inc.
Glenmark 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, Glenmark is the first approved applicant for such competitive generic therapy and is eligible for 180 days of CGT exclusivity upon commercial marketing.
According to IQVIA sales data for the 12 month period ending January 2021, the Cardizem SR Extended‐Release Capsules, 60 mg, 90 mg, and 120 mg market achieved annual sales of approximately $56.7 million*.
Glenmark's current portfolio consists of 170 products authorized for distribution in the U.S. marketplace and 42 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," the company stated.
Glenmark Pharmaceuticals Ltd. (GPL) is a global pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.
Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology.