Octapharma USA, part of Swiss-based human protein products manufacturer Octapharma AG, is expanding its manufacturing capacity for Octagam 10% [Immune Globulin Intravenous (Human) 10% (100 mg/mL) Liquid Preparation].
The U.S. Food and Drug Administration (FDA) has given the green light for the company's manufacturing facility in Vienna, Austria, to produce Octagam 10% for the U.S. market.
Octagam 10% is an FDA-approved treatment for adults with chronic Immune Thrombocytopenic Purpura (ITP), a platelet disorder that can result in easy or excessive bruising and bleeding. It was launched in the United States in October 2014.
This approval means that Octagam 10% for the U.S. market can now be manufactured at Octapharma's FDA-licensed facilities in both Stockholm, Sweden, and in Vienna, expanding the availability of the product.
Octagam 5% [Immune Globulin Intravenous (Human) 5% (50 mg/mL) Liquid Preparation] to treat Primary Humoral Immunodeficiency (PI) is also manufactured at the company's FDA-licensed manufacturing facilities in Stockholm and Vienna.
The decision was welcomed by Flemming Nielsen, president of Octapharma USA, who said that it will enhance production flexibility.
Octapharma also has state-of-the-art manufacturing facilities in Lingolsheim, France; Dessau and Springe, Germany; and Mexico City, Mexico. Its production facilities perform plasma fractionation and purification to produce biopharmaceuticals, as well as product labeling, packaging, storage and distribution. The company conducts research and development in Berlin, Frankfurt and Heidelberg, Germany, and in Lachen, Switzerland.