Glenmark, Lupin and 1 other recall products in US over manufacturing issues
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-04-11 09:32 GMT | Update On 2024-04-11 09:32 GMT
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New Delhi: Glenmark, Lupin, and Natco Pharma, key players in the generic drug industry, are recalling products in the American market due to manufacturing concerns, as per the US health regulator.
According to PTI, the latest Enforcement Report by the US Food and Drug Administration (USFDA) stated that Lupin is recalling 26,352 bottles of Rifampin Capsules (300 mg) in the US market. The product is an antibiotic medication.
The affected lot has been produced by the drug firm at its Aurangabad-based facility and marketed in the American market by its Baltimore-based unit Lupin Pharmaceuticals, Inc.
As per the USFDA, the drug maker is recalling the lot for being "Subpotent". The company issued the Class II recall on March 21 this year.
USFDA stated that Glenmark is recalling 6,528 bottles of Diltiazem Hydrochloride extended-release capsules due to "Failed Dissolution Specifications''.
The drug, used to treat high blood pressure, was marketed in the US market by New Jersey-based Glenmark Pharmaceuticals Inc., USA, a unit of the Mumbai-headquartered drug firm.
The firm initiated the Class II recall on March 26, 2024.
Hyderabad-based Natco Pharma is recalling 30 bottles of Lansoprazole delayed-release capsules, used to treat heartburn, in the American market, due to "CGMP Deviations", USFDA stated.
The product is manufactured by the company in its Kothur (Telangana) based formulation plant.
The company initiated the Class II recall on March 27 this year.
As per the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
India is the largest supplier of generic medicines with around 20 per cent share in the global supply by manufacturing 60,000 different generic brands across 60 therapeutic categories.
The products manufactured in the country are shipped to over 200 countries around the globe, with Japan, Australia, West Europe and the US as the main destinations.
India has the highest number of USFDA compliant companies with plants outside of the USA. As per the fiscal year, 2022 report on State of Pharmaceutical Quality published by USFDA, India boasts of more than 600 USFDA registered manufacturing sites, constituting nearly 12.5 per cent of all registered manufacturing sites operating outside the US.
Read also: Sun Pharma recalls 55000 bottles of generic drug to treat gout from American market
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