Glenmark Pharmaceuticals has announced the recall of 6,528 bottles of a medication designed to address high blood pressure issues in the American market. This decision came as a response to the US Food and Drug Administration (USDA) revealing that the specific lot of Diltiazem Hydrochloride extended-release capsules from India did not meet the dissolution specifications set by the authorities. The recall was initiated by the New Jersey-based Glenmark Pharmaceuticals Inc due to the discovery of 'failed dissolution specifications', as pointed out by the USDA in its recent enforcement report.
The issue surfaced when an 'Out of Specification (OOS)' result was detected during a dissolution test at the 12th month mark in a long-term stability study. Subsequently, Glenmark Pharmaceuticals launched a Class II recall of the drug throughout the US on March 26. The USFDA classifies a Class II recall as being necessary when the usage of a defective product could lead to temporary or medically reversible adverse health effects, although the likelihood of severe consequences is low.
Despite this setback, India remains a major global supplier of generic drugs, holding about a 20 percent market share. The country exports its pharmaceutical products to prominent destinations such as Japan, Australia, Western Europe, and the United States, with a production portfolio that includes 60,000 different generic brands spanning 60 therapeutic categories. Additionally, India boasts the highest number of USDA-compliant companies with manufacturing facilities located outside the United States.