NEW DELHI: Strides Shasun said it has received approval from the US health regulator for anti-biotic and anti-protozoal tablets Metronidazole.
The company has received approval from the US Food and Drug Administration (USFDA) for Metronidazole tablets USP, 250 mg and 500 mg, Strides Shasun said in a BSE filing.
The product received approval in 17 months under the USFDA’s new product clearance regime of GDUFA. The product is ready for immediate launch, it added.
According to IMS sales data, the US market for Metronidazole tablets is around USD 50 million.
The company will manufacture the product at its oral dosage facility in Bengaluru.