Pharmacosmos Inc., has approval to begin manufacturing Uniferon 200 in an alternate site manufacturing facility, the company said in a release. The alternate site manufacturing facility has previously been approved by the U.S. Food and Drug Administration (FDA) for manufacturing of human grade injectable products for the past 10 years, making 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 and business director at Pharmacosmos Inc. in a release. “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.”
The U.S. swine industry experienced widespread concern of an injectable iron shortage in fall 2020, which could have been highly disruptive and potentially devastating to U.S. swine health, welfare and production, the company said in a release.
Pharmacosmos Inc. responded to the animal drug shortage concerns by stockpiling raw materials and finished product to meet the needs of swine producers, the company noted.
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. Baby pigs are very susceptible to iron deficiency anemia. Because of this, deficiency anemia in litters of baby pigs poses a risk to both animal health, welfare and productivity, the company said in a release. Pharmacosmos said injection of iron shortly after farrowing is an effective and globally established “best practices method” to prevent iron deficiency anemia in baby pigs.
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