Sunday, October 01, 2023 9:17 PM http://us.uniferon.com/questions-and-answers/faq.aspx
Find answers to the most often asked questions about Uniferon® 200
Yes, Uniferon® 200 is the subject of a CVM/FDA approved product registration, which is classified as an approved New Animal Drug Application (NADA). The product registration is identified as NADA #134-708.
Yes, Uniferon® 200 is focused entirely on the iron deficiency needs of baby pigs and the product is manufactured and marketed as a sterile injectable product.
Simply e-mail us at uniferon.us@pharmacosmos.com or call (908) 769-7045. You'll find our complete contact information here.
Pharmacosmos A/S is a privately owned, independent pharmaceutical company based in Denmark. Pharmacosmos A/S is a leading global supplier of iron therapy for human and veterinary use and has been supplying the U.S. veterinary market with the high-quality, FDA-approved raw material 100 and 200 mg/mL non sterile iron dextran bulk liquids since the mid-1980's.
Today, Pharmacosmos A/S is a leading specialist in iron therapy and associated pharmaceutical research, and the company develops, manufactures and markets innovative therapies for the treatment of iron deficiency in both human and animal medicine.
Pharmacosmos, Inc. is a wholly-owned U.S. subsidiary of Pharmacosmos A/S and it is the sponsor / owner of the FDA approved New Animal Drug Application (NADA) #134-708 for Uniferon® 200.
The finished products are manufactured for Pharmacosmos, Inc., a U.S. subsidiary that owns the Uniferon® 100 and Uniferon® 200 product registrations, by a U.S. FDA approved domestic contract manufacturer that was specifically approved by the Center for Veterinary Medicine (CVM) of the FDA.
The 100 and 200 mg/mL non-sterile iron dextran bulk liquid active pharmaceutical ingredients (APIs) utilized in the production of the Uniferon® 100 and 200 final dosage form (FDF) products are manufactured in the FDA approved Pharmacosmos A/S facility in Holbaek, Denmark.
Uniferon® 200 contains 200 mg of elemental iron per mL, which is double the strength of 100 mg/mL iron products.
Current U.S. swine production industry standards indicate that all baby pigs should receive a standard 200 mg of iron treatment regimen. The utilization of a one (1) mL dosage of Uniferon® 200 ensures adequate iron supplementation, reduces the stress of unnecessary handling and the potential injury to the baby pigs from a second injection and, thus, reduces the swine producer labor costs as well.
We hope you found the answers you were looking for, but if you have further questions please send us an email at uniferon.us@pharmacosmos.com.