Fresenius to Manufacture Saline in Mexico for U.S. Dialysis Market

WALTHAM, Mass.—The U.S. Food and Drug Administration has approved Fresenius Medical Care’s manufacturing facility in Mexico to make and distribute saline solution for dialysis treatment in the United States, the company announced June 19.

The initial production capacity at the Guadalajara, Mexico, facility will exceed 5 million liters annually and is expected to increase to more than 20 million liters over the next few years, according to Fresenius.

The company said it was looking for FDA approval in order to meet the increased demand for saline in the United States. Fresenius said it is the first company to meet FDA requirements for the distribution of saline from Mexico to the United States.

“The company is very pleased that, after a thorough examination of several days, the FDA has found the water system at Guadalajara to fulfill its high quality standards,” Fresenius wrote in a news release.

Saline plays an integral role in dialysis treatments and is normally used to maintain liquid volume in the blood, according to Fresenius. Additionally, Fresenius uses the saline to wet the blood circuit during hemodialysis. Near the end of the treatment, the saline is also used to push the blood back into the patient.