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