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
kporter@dmhadv.com
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.