INDIA- Leading generic drug manufacturers Glenmark, Sun Pharma, Dr. Reddy’s, and Jubilant Cadista have withdrawn several products due to various problems in the US market.
Mumbai-based pharmaceutical company Glenmark is recalling more than 650,000 tubes of a generic skin treatment ointment due to production problems. This was reported in the US Food and Drug Administration’s (FDA) most recent Enforcement Report.
The affected lot of Tacrolimus Ointment, which is used to treat eczema, is being recalled by the company’s affiliate Glenmark Pharmaceuticals Inc. of New Jersey because of a “Defective Container.”
According to the investigation, Glenmark Pharmaceuticals Inc. marketed the afflicted lot throughout the US after producing it in India.
This year’s nationwide Class III recall was started by the firm on July 11 and the FDA has classified the recall as a Class III one.
According to the FDA, Recalls are actions taken by a company to take a product off the market. They may be carried out on a company’s initiative, at the (Food and Drug Administration’s (FDA) request, or according to a statutory order from the FDA.
The FDA further defines a Class II recall as 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.
A Class III recall is a situation in which the use of or exposure to a violative product is not likely to cause adverse health consequences.
The USA is unquestionably the world’s largest market for pharmaceutical goods and in 2019, it was predicted that the generic medication market would be worth about USD 115.2 billion.
Similarly, on June 27 of this year, Sun Pharma, began Class II recall in the US for 9,552 bottles of the epilepsy medication Divalproex Sodium delayed-release tablets due to “Failed Dissolution Specifications.”
The Cranbury firm-based pharmaceutical Industry delivered the impacted lot in the US after it was manufactured at the company’s Halol plant in Gujarat, India.
Dr. Reddy’s Laboratories’ US-based division has also recalled 5,531 boxes of Lansoprazole.
The New Jersey-based company has withdrawn the products due to missed disintegration standards in two dosages. The Class II nationwide recall was started on July 13.
In addition, 38,160 bottles of Irbesartan Tablets (150 and 75 mg) have been recalled by US-based generic pharmaceutical, Jubilant Cadista Pharmaceuticals.
According to the FDA, Jubilant Generics’ Roorkee factory produced the impacted batch and on July 18, the Salisbury-based pharmaceutical company started the Class II recall.
The USA is unquestionably the world’s largest market for pharmaceutical goods and in 2019, it was predicted that the generic medication market would be worth about USD 115.2 billion.
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