Glenmark Pharmaceuticals recalls India-made hypertension drug in the US
What's the story
Glenmark Pharmaceuticals, a global pharmaceutical leader, has initiated a recall of 6,528 bottles of Diltiazem Hydrochloride in the United States. The medication is commonly used to treat hypertension.
The recall was triggered by failed dissolution specifications, as reported by the US Food and Drug Administration (USFDA).
The Mumbai-based company's US subsidiary is responsible for recalling this specific batch of extended-release capsules.
Regulatory report
USFDA reports on Glenmark's drug recall
The recall details were disclosed in the latest enforcement report issued by the US health regulator.
The report clarified that the batch was manufactured in India and is being recalled by Glenmark Pharmaceuticals Inc, based in New Jersey.
The reason for this action was identified as "failed dissolution specifications."
An "Out of Specification (OOS) was reported in a test of dissolution at the 12th month time point in long-term stability study," according to the USFDA.
Recall details
Classification and timeline
The recall process was initiated on March 26 this year. The USFDA has classified it as a Class II recall.
This classification is used when there is a possibility of temporary or medically reversible adverse health consequences or when the likelihood of serious adverse health consequences is low.
The latest incident provides insight into the potential impact of the recalled medication on patients' health.
Scenario
India's dominance in generic medicine supply
India, manufacturing 60,000 generic brands across 60 therapeutic categories, leads as the largest provider of generic medicines globally, holding a 20% share in the market.
These products are distributed to over 200 countries, with Australia, Western Europe, Japan, and the US being the primary destinations.
Additionally, India boasts the highest number of USFDA-compliant companies with manufacturing facilities outside the US.