Strides Arcolab receives US FDA approval for Polyethylene Glycol 3350

15 Apr 2015 Evaluate

Strides Arcolab has received approval from the United States Food & Drug Administration (USFDA) for Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride for Oral Solution, 420 grams/11.2 grams/5.72 grams/1.48 grams/4 Liters. According to IMS data, the US market for Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride for Oral Solution is approximately USD 20 Million.

The product will be manufactured at the Company's Oral dosage facility at Bangalore and marketed by Strides in the US Market. It is used for bowel cleansing prior to colonoscopy. Polyethylene glycol 3350 is an osmotic laxative, and along with the electrolytes, the combination is used in preparation for colonoscopy in adults and pediatric patients aged six months or greater.

Strides Arcolab is a global pharmaceutical company headquartered in Bangalore, India that develops and manufactures wide range of IP-lead niche pharmaceutical products with an emphasis on sterile injectables.

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