Aurobindo Pharma gets USFDA approval to market drug for type-II diabetes
July 24, Hyderabad: Hyderabad-based drugmaker Aurobindo Pharma on Monday said that their anti-diabetic drug Metformin Hydrochloride extended release tablets USP got final approval from United States Food and Drug Administration (USFDA). The company said it was all set to launch the drug in US market soon.
Metformin Hydrochloride is a generic version of Bristol Myers Squibb”s Glucophage XR brand that is used to improve glycemic control in patients suffering from type-2 diabetes and has annual sales of around US$230 million.
The company said the product had been approved for sales in the US market out of its Unit III formulations facility in Hyderabad, which till recently was under an import ban by USFDA.
The tablets are indicated to control glucose levels in patients with type II diabetes.
The company also said that the product will be made in Hyderabad and exported to the US. The company’s Hyderabad plant had been slapped with an import ban by USFDA last year after an inspection revealed that the plant’s facilities weren’t up to the mark but the ban has been lifted now.
Following USFDA’s inspection of the unit in March this year, the company has recently started getting the US drug regulator’s approvals for drugs like blood thinner clopidogrel and psychiatric drug Quetiapine. Currently, Aurobindo’s other banned unit VI, which makes cephalosporin based drugs, is awaiting the clearance from USFDA.
With the approval of metformin hydrochloride, Aurobindo Pharma now has a total of 153 ANDA (abbreviated new drug applications) approvals from USFDA, including 127 final approvals and 26 tentative approvals.
Aurobindo Pharma Limited is a pharmaceutical manufacturing company headquartered at Hyderabad, India. The company manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company markets these products in over 125 countries.
News Gathered by India News
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