FDA accepts Uniferon 200 alternate manufacturing site

June 4, 2021

FDA accepts Uniferon 200 alternate manufacturing site, preventing industry shortage.

Pharmacosmos, Inc., the manufacturer of Uniferon 200, will address swine producer concerns about an animal drug shortage of injectable iron in the U.S. by bringing an alternate manufacturing facility online.

WATCHUNG, N.J. (June 3, 2021) - Pharmacosmos, Inc. announces approval to immediately begin manufacturing Uniferon 200 in an alternate site manufacturing facility. The alternate site manufacturing facility has already been approved by the U.S. Food and Drug Administration (FDA) for manufacturing of human grade injectable products for over ten years, which will make Uniferon 200 the only injectable iron product for animal use both sterilized and bottled in an FDA approved human drug manufacturing facility.

"This approval from the FDA allows Pharmacosmos, Inc. to take additional steps to secure an uninterrupted flow of injectable iron to the U.S. veterinary market." says Jimmy Heisel, sales & business director at Pharmacosmos, Inc. "Working closely with U.S. FDA authorities, Pharmacosmos, Inc. is totally committed to supporting the U.S. swine industry by maintaining ample stocks of Uniferon 200 to prevent an injectable iron shortage from becoming a burden for producers."

Uniferon 200 (Iron Dextran Complex Injection, 200 mg/mL x 100-mL product) is designated as a Medically Necessary Veterinary Product (MNVP) by the FDA, and it has been the leading Injectable iron brand in the U.S. veterinary market since its introduction over 10 years ago.

In the fall of 2020, the U.S. swine industry experienced widespread concern of an injectable iron shortage, which could have been highly disruptive and potentially devastating to U.S. swine health, welfare and production. Pharmacosmos, Inc. immediately responded to the animal drug shortage concerns by stockpiling raw materials and finished product to meet the needs of swine producers.

"Since Pharmacosmos, Inc. launched Uniferon 200 in March of 2011, the U.S. veterinary market has seen a stable supply of injectable iron," says Heisel. "The above referenced alternate site manufacture of Uniferon 200 solidifies our ability to keep the market fully supplied and to ensure that no baby pigs suffer from iron deficiency anemia due to a lack of product availability."

For more information and updates about animal drug shortages, visit the FDA website.

Contact: Kari Porter
913- 488-2794

About Injectable Iron

Baby pigs are very susceptible to iron deficiency anemia. Therefore, iron deficiency anemia in litters of baby pigs poses a risk to both animal health, welfare, and productivity. An injection of iron shortly after farrowing is an effective and is a globally established "best practices method" utilized to prevent iron deficiency anemia in baby pigs.

About Uniferon 200

Uniferon 200 is a modern and much improved iron hydrogenated dextran, based upon a very low impurity profile formulation, whereby this source of injectable iron for baby pigs has been approved by numerous healthcare authorities for global use.

Pharmacosmos manufactures iron dextran of high quality and unique purity, which is distributed to human and animal drug customers worldwide. Uniferon 200 is the only injectable iron brand for baby pigs approved by healthcare authorities in the EU, in the U.S. and in Asia.

About Pharmacosmos

Pharmacosmos Inc, located in Watchung, NJ as a fully owned subsidiary of Pharmacosmos A/S. is dedicated to the sales of veterinary pharmaceuticals for the treatment and prevention of iron deficiency Anemia, including Uniferon 200.

Headquartered in Holbaek, Denmark, Pharmacosmos A/S is a family-owned, international healthcare company with more than 50 years of innovation and leadership in iron- and carbohydrate-based treatments and solutions for human and animal use.

A research-based company, the Pharmacosmos A/S ongoing R&D program focuses on improving the lives of patients with sub-clinical and full-scale iron deficiency anemia. More than 1 billion people live with iron deficiency anemia and it is the leading cause of death for an estimated 180,000 people world-wide every year. This makes sub-clinical and full-scale iron deficiency anemia one of the largest global health challenges of the current time.

Pharmacosmos A/S has subsidiaries in the US, China, Nordics, Germany, UK and Ireland, and its products are marketed in more than 80 countries around the world. The Pharmacosmos A/S manufacturing facilities located in Denmark have supported global healthcare authority approvals, among others, by the Danish Medicines Agency and the U.S. FDA.