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Aurobindo Pharma has received US health regulator’s approval to manufacture and market Metronidazole tablets, used to treat various kinds of infections, in the US market.
The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Metronidazole tablets in strengths of 250 mg and 500 mg, the Hyderabad-based firm said in a statement.
“Aurobindo will commence shipping shortly,” it added.
The company’s product, which is the generic equivalent of GD Searle LLC’s Flagyl, is used in treating various infections caused by bacteria and some other organisms.
The medicine can also be used to prevent infection during a surgery.
According to IMS data, the product has an estimated market size of $ 58 million for the twelve months ended March, 2015.
“This is the 37th abbreviated new drug application (ANDA) to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-betalactam products,” the drug firm said.
Aurobindo now has a total of 194 ANDA approvals from the USFDA.
Aurobindo shares today ended at Rs 1,361.55 apiece on the BSE, down 0.97 per cent from previous close.
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