Grifols' physiological saline solution produced in its Murcia facility receives U.S. FDA approval


05.06.2017

  • The FDA (Food & Drug Administration) approval allows Grifols to market its physiological saline solution in 500-millimeter polypropylene bags in the U.S. hospital sector and guarantees the Group's self-sufficiency. The product is manufactured in Grifols' production plant in Las Torres de Cotillas (Murcia)
  • Grifols' U.S. network of plasma-donation centers will also use the IV solution as a preventative measure to restore the circulatory volume of donors
  • As Grifols continues to drive the internationalization of its Hospital Division, this approval opens up new possibilities for future authorizations to sell other products manufactured in its Parets del Vallès (Barcelona) and Las Torres de Cotillas (Murcia) facilities. It also confirms the company's strategy to promote complementarity of its products and services among business divisions
  • Grifols' new industrial complex in Murcia currently has a production capacity of 40 million units per year, although the company is investing more than Euros 5 million to increase this capability

Barcelona, June 5th, 2017.- Grifols (MCE: GRF, MCE: GRF.P y NASDAQ: GRFS), one of world's top three producers of plasma-derived medicines and a forerunner in the research and development of therapeutic alternatives that drive scientific and social advancements, has received approval from the United States' health authorities (Food & Drug Administration, or FDA) to market its 500-ml physiological saline solution (0.9% sodium chloride) in the U.S. market. The company currently manufactures this product in its industrial complex in Las Torres de Cotillas (Murcia, Spain).

This approval has given added momentum to the internationalization process underway of Grifols' Hospital Division, since the United States represents one of the key markets in the growth strategy of this business line. There is rising demand for this type of solution in the U.S. market and the achievement of this first authorization marks an important step forward that opens up new possibilities of future authorizations for other products manufactured in Grifols' Murcia and Barcelona facilities.

Grifols will also employ this physiological saline solution in its U.S. network of plasma-donation centers, hence ensuring self-sufficiency. The infusion of 500-ml physiological saline in plasma donors post-donation is an additional preventative measure that the company has adopted to help replace fluids and restore the circulatory volume in donors.

The Group's nearly 180 plasma-donation centers will require approximately 10 million units a year of this product, although this figure will rise as the number of the company's centers in the United States increases.

In this regard, the FDA approval also confirms Grifols' strategy of fostering synergies among its business lines by developing complementary products and services for its divisions.

Grifols invests Euros 5 million in its Murcia plant to increase the production of IV solutions

Grifols' Murcia facility currently has a production capacity of 40 million units of IV solutions in polypropylene bags, of which approximately 10 million units will represent the FDA-approved physiological saline (500 ml) in 2018.

In 2017, Grifols completed the expansion of the facility, following a Euro 5 million investment in the last phase. The expansion includes the manufacture of a fourth production line of IV solutions that will enable the plant to increase its production capacity by an additional 12 million units to meet the increasing market demand for this type product. The fourth line is scheduled for launch in 2017.

Grifols has had a presence in Murcia since 1990. Since then, the company has invested more than Euros 60 million and created over 350 jobs.

The production plant in Las Torres de Cotillas is accredited by the FDA, among other regulating bodies.