Strides Shasun gets USFDA nod for anti-biotic and anti-protozoal tablets
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.
NEW DELHI: Strides Shasun today 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.
The stock was trading 2.21 per cent up at Rs 1,134 on BSE.
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