The U.S. Food and Drug Administration recently completed its regulatory inspection of the production site in Berlin and issued FARCO-PHARMA approval for the marketing of a sterile lubricant in disposable syringes in the United States. FARCO-PHARMA has been producing and selling the sterile catheter lubricant under the brand name GLYDO® on the U.S. market since October 2014.
Medicinal products for the U.S. market are manufactured at the same production site and conform to the same high quality standards as those for other well-known FARCO products, such as Instillagel® and Endosgel® for the German and European markets.
This represents a further milestone for FARCO-PHARMA. As the German specialist for sterile urological lubricants, we have now made it our goal to expand sales within the U.S. market in collaboration with a sales and distribution partner.
In addition to the FDA approval, FARCO-PHARMA has been meeting all domestic and international market requirements through our production activities at GMP-certified production sites and the certification of our quality assurance system and medical devices in accordance with EN ISO 9001 and EN ISO 13485 in compliance with European law for over 20 years now.