Drug makers Glenmark, Sun Pharma, Dr Reddy’s recall products in US

Major generic drug makers Glenmark, Sun Pharma, Dr. Reddy’s and Jubilant Cadista are recalling several products in the US market, the world’s largest drug market, for various issues.

According to the latest US Food and Drug Administration (USFDA) enforcement report, Mumbai-based pharmaceutical company Glenmark is recalling more than 6.5 lakh tubes of a generic skin treatment ointment in due to manufacturing issues.

New Jersey-based Glenmark Pharmaceuticals Inc, a subsidiary of the company, is recalling the affected lot of tacrolimus ointment, which is used to treat eczema, due to “faulty container”, it added .

The company launched the nationwide Class III recall on July 11 this year.

The affected lot was manufactured in India and distributed in the United States by Glenmark Pharmaceuticals Inc, the report said.

According to the USFDA, a Class III recall is initiated in a “situation in which use of or exposure to an offending product is not likely to result in adverse health consequences.”

According to the USFDA, Sun Pharma is recalling 9,552 bottles of delayed-release tablets of Divalproex Sodium, a drug for the treatment of epilepsy, due to “failed dissolution specifications.”

The affected batch was produced at the company’s Halol facility in Gujarat and distributed in the United States by Sun Pharmaceutical Industries, Inc., based in Cranbury.

The drug launched the Class II recall in the United States on June 27 this year.

Similarly, the US branch of Dr. Reddy’s Laboratories is recalling 5,531 cartons of lansoprazole delayed-release orally disintegrating tablets in two strengths due to failure of dissolution specifications.

The New Jersey-based company launched the nationwide Class 11 recall on July 13.

In addition, Jubilant Cadista Pharmaceuticals is recalling 38,160 bottles of irbesartan tablets (150 and 75 mg), used to treat high blood pressure.

The affected lot was produced at Jubilant Generics’ Roorkee plant, the USFDA said.

The Salisbury-based pharmaceutical company launched the Class II recall on July 18.

According to the US health regulator, a Class II recall is initiated in a situation where use of or exposure to an infringing product may result in temporary or medically reversible adverse health consequences or when the likelihood of such consequences serious adverse health effects is low.

The US generic drug market was estimated at around USD 115.2 billion in 2019. It is by far the largest pharmaceutical market in the world.

In the last fiscal year, India’s pharmaceutical exports amounted to around $24.62 billion, with the United States, United Kingdom, South Africa, Russia and Nigeria emerging as the five main destinations.

(Only the title and image of this report may have been edited by Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

Leave a Comment