Strides receives USFDA approval for Polyethylene Glycol 3350 and Electrolytes for Oral Solution USP

Strides Pharma Science announced that its step‐down wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for Polyethylene Glycol 3350 and Electrolytes for Oral Solution USP, 236 grams/2.97 grams/6.74 grams/5.86 grams/22.74 grams/4 Liter from the United States Food & Drug Administration (US FDA). The product is a generic version of GoLYTELY of Braintree Laboratories, Inc.

Strides has already garnered an important market share for Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution (IMS market share at 22%) and Polyethylene Glycol 3350, Powder for Solution (OTC). With the current approval, Strides now offers a complete range of PEG 3350 Laxatives for the US markets comprising of 3 approved products addressing a combined Rx and OTC opportunity of ~US$ 400 Mn as per IMS and IRi data. The product will be manufactured at flagship facility in Bangalore and will be marketed by Strides Pharma Inc. in the US market.

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