QOL Medical awarded US FDA approval to manufacture Sucraid (sacrosidase) Oral Solution at facility in Clearwater, Florida
3 October 2018 -

Biopharmaceutical company QOL Medical LLC revealed on Tuesday the receipt of approval from the US Food and Drug Administration (FDA) to manufacture Sucraid (sacrosidase) Oral Solution for the treatment of congenital Sucrase-Isomaltase Deficiency at its wholly owned manufacturing facility in Clearwater, Florida.

Following this US FDA approval, the Sucraid drug shortage has been resolved as well as eliminating the need for informed consents, assents, physician acknowledgments and patient questionnaires for all Sucraid prescriptions.

The company has developed an improved manufacturing process for sacrosidase production, designed and built a wholly owned cGMP-compliant manufacturing facility, and hired an experienced manufacturing and quality team to assure this goal.

In addition, the long-term supply of Sucraid continues to be the company's top priority. Sucraid is now available as a regular prescription exclusively from US Bioservices.

According to the company, Sucraid (sacrosidase) Oral Solution is an enzyme replacement therapy for the treatment of genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID). Sucraid can help improve the breakdown and absorption of sucrose (table sugar) from the intestine and can help relieve the gastrointestinal symptoms of CSID. The patients with CSID often experience watery diarrhea due to the osmotic effect of malabsorbed sugars as well as gas, bloating and abdominal pain caused by bacterial fermentation of undigested sucrose which releases methane and hydrogen in the colon.