New Delhi: Major generic drug makers Lupine, Glenmark and Natco Pharma are recalling their products from the US market due to manufacturing issues, according to the US health regulator.
As per the latest enforcement report by the US Food and Drug Administration (USFDA), Lupine is recalling 26,352 bottles of antibiotic drug Rifampin Capsules (300 mg) in the US market.
The affected lots are produced by the drug company at its Aurangabad facility and its Baltimore-based unit Lupi Pharmaceuticals, Inc. It has been marketed in the US market by.
According to the USFDA, the drug manufacturer is recalling the lot due to it being "subpotent". The company had issued a Class II recall on March 21 this year.The USFDA said 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 pharmaceutical company.
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 US market due to "cGMP deviations", the USFDA said.
The product is manufactured by the company at its Kothur (Telangana) base formulation plant.The company initiated the Class II recall on March 27 this year.
According to the USFDA, a Class II recall is initiated when use of or exposure to a violative product is likely to cause temporary or medically reversible adverse health consequences or where the likelihood of serious adverse health consequences is very low. Is.
India is the largest supplier of generic drugs with about 20 per cent share in the global supply, manufacturing 60,000 different generic brands across 6 therapeutic categories.
Products manufactured in the country are shipped to more than 200 countries around the world, with Japan, Australia, Western Europe and the US being the main destinations.
India has the highest number of USFDA compliant companies with plants outside the USA.According to the FY 2022 Report on the State of Pharmaceutical Quality published by the USFDA, there are more than 600 USFDA registered manufacturing sites in India, which is about 12.5 percent of all registered manufacturing sites operating outside the US.
As per the latest enforcement report by the US Food and Drug Administration (USFDA), Lupine is recalling 26,352 bottles of antibiotic drug Rifampin Capsules (300 mg) in the US market.
The affected lots are produced by the drug company at its Aurangabad facility and its Baltimore-based unit Lupi Pharmaceuticals, Inc. It has been marketed in the US market by.
According to the USFDA, the drug manufacturer is recalling the lot due to it being "subpotent". The company had issued a Class II recall on March 21 this year.The USFDA said 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 pharmaceutical company.
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 US market due to "cGMP deviations", the USFDA said.
The product is manufactured by the company at its Kothur (Telangana) base formulation plant.The company initiated the Class II recall on March 27 this year.
According to the USFDA, a Class II recall is initiated when use of or exposure to a violative product is likely to cause temporary or medically reversible adverse health consequences or where the likelihood of serious adverse health consequences is very low. Is.
India is the largest supplier of generic drugs with about 20 per cent share in the global supply, manufacturing 60,000 different generic brands across 6 therapeutic categories.
Products manufactured in the country are shipped to more than 200 countries around the world, with Japan, Australia, Western Europe and the US being the main destinations.
India has the highest number of USFDA compliant companies with plants outside the USA.According to the FY 2022 Report on the State of Pharmaceutical Quality published by the USFDA, there are more than 600 USFDA registered manufacturing sites in India, which is about 12.5 percent of all registered manufacturing sites operating outside the US.
