Glenmark, Sun Pharma and Dr Reddy’S recall products in US


By CNBCTV18.COM IST (Released)

mini

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.

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 an affected lot of tacrolimus ointment used to treat eczema due to “defective containers”. The company launched the nationwide Class III recall on July 11 this year.

The report states that the affected lot was manufactured in India and distributed in the United States by Glenmark Pharmaceuticals Inc. According to the USFDA, a Class III recall is initiated in a “situation in which use or exposure to a infringing product is not likely to cause adverse health consequences”.

Sun Pharma is recalling 9,552 bottles of Divalproex Sodium delayed-release tablets, a drug for the treatment of epilepsy, due to “non-compliant dissolution specifications”. The affected batch was produced at the company’s Halol factory in Gujarat and distributed in the United States by Cranbury-based Sun Pharmaceutical Industries. 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 a Class II recall on July 18. According to the US health regulator, a Class II recall is initiated in a situation where use or exposure to an offending product may cause temporary or medically reversible adverse effects. serious or when the likelihood of serious adverse health consequences is remote.

The US generic drug market was estimated at around $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.

Read also :


cnbctv18-forexlive-benzinga

Not all news on the site expresses the point of view of the site, but we transmit this news automatically and translate it through programmatic technology on the site and not from a human editor.
Back to top button