Strides Shasun has received approval from the United States Food & Drug Administration (USFDA) for Metronidazole Tablets USP, 250 mg and 500 mg. The product received approval in 17 months under the new GDUFA regime. The product is ready for immediate launch. Metronidazole Tablets are indicated for treatment of wide variety of infections caused by particular types of bacteria and parasites.
According to IMS data, the US market for Metronidazole Tablets USP, 250 mg and 500 mg is approximately $50 million. The product will be manufactured at the company’s oral dosage facility at Bangalore and marketed by Strides in the US Market.
Strides Shasun (formerly known as Strides Arcolab) is engaged in manufacturing, sale and export of pharmaceutical products. It offers general tablets, hard gelatin and soft gelatin capsules, sachets, potent drugs and and semi-solids.