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Strides receives USFDA approval for Polyethylene Glycol 3350, Electrolytes for Oral Solution

Strides receives USFDA approval for Polyethylene Glycol 3350, Electrolytes for Oral Solution

Mumbai, Dec 24 (UNI) Pharma Major, Strides Pharma Science Limited

today announced that its step-down wholly owned subsidiary, Strides

Pharma Global Pte. Limited, 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.

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 USD 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.

The company has 80 cumulative ANDA filings with USFDA, of which 55

ANDAs have been approved, including 11 approvals received in FY 19.

UNI JS RJ 1540

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