Homegrown drug majors Lupine, Glenmark and Dr Reddy’s Laboratories are recalling different products in the US, the world’s largest market for medicines, due to deviation from standard manufacturing norms.
As per the latest enforcement report by the US Food and Drug Administration (USFDA), Lupine is recalling over 33 lakh bottles of Losartan Potassium tablets, in different strengths, in the US market.
The company is also recalling close to 39 lakh bottles of Losartan Potassium and Hydrochlorothiazide tablets in the market.
Both the medications are used to treat high blood pressure and heart disease.
According to USFDA, the Mumbai-based drug maker is recalling the affected lot due to “CGMP (current good manufacturing practices).
The Baltimore-based Lupine Pharmaceuticals Inc, a unit of Mumbai-based Lupine, has initiated the nationwide Class II recall March 31 this year.
The affected lot has been manufactured at Lupine’s Pithampur-based plant in Madhya Pradesh. The lot has been distributed in the US by Baltimore-based Lupine Pharmaceuticals Inc, the report stated.
Similarly, Mahwah (New Jersey) based Glenmark Pharmaceuticals Inc, is recalling over 32,000 bottles of Zonisamide capsules in the US market.
The medication is used to treat and prevent epilepsy. As per USFDA, the US firm, a unit of Mumbai-based Glenmark Pharmaceuticals, is recalling the affected lot due to “CGMP deviations”.
The drug maker initiated the nationwide (US) Class II voluntary recall on April 25 this year.
Further, Princeton (New Jersey) based Dr Reddy’s Laboratories, Inc. is recalling 252 blister packs of Lansoprazole delayed-release orally disintegrating tablets which is used to treat peptic ulcer disease, gastroesophageal reflux disease, and Zollinger–Ellison syndrome.
As per the US health regulator the company, a unit of Hyderabad-based Dr Reddy’s Laboratories, is recalling the affected lot due to “failed dissolution specifications”.
The drug firm initiated the Class II recall on April 15 this year. Besides, a US-based subsidiary of Gujarat-based Torrent Pharmaceuticals, is recalling 24,888 bottles of Pantoprazole sodium delayed-release tablets due to “CGMP deviations”.
The medication is used for treating acid-related diseases of the stomach and intestine such as heartburn, acid reflux and peptic ulcer disease.
The company initiated the Class II recall on April 11 this year. As per the USFDA, a Class II recall is initiated in a situation in which 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.
According to industry estimates, the US generic drug market was estimated to be around USD 115.2 billion in 2019. PTI MSS MR
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