ALBUQUERQUE, N.M., Nov. 19, 2014 /PRNewswire/ -- AMRI (NASDAQ:
AMRI) today announced that its Albuquerque, N.M. sterile injectable facility
has resumed full manufacturing operations. As previously announced,
in September 2014 AMRI identified an
environmental deviation in one manufacturing suite as a result of a
weather related business interruption. The resulting
remediation has now been completed.
Commenting on its operations, William S.
Marth, AMRI's President and Chief Executive Officer, said:
"We are pleased to report that all suites at our OsoBio Albuquerque
aseptic manufacturing facility are fully operational. I would like
to acknowledge and thank our colleagues and vendors for their
dedicated efforts in remediating the affected manufacturing suite
as quickly as possible."
AMRI's OsoBio facility is an established provider of cGMP
manufacturing and sterile filling of parenteral drugs using
specialized technologies, including lyophilization. With its cGMP
aseptic filling expertise, OsoBio supports commercial scale
production of liquid-filled and lyophilized parenterals.
These services are provided for both small molecule drug products
as well as biologicals. Oso Biopharmaceutical Manufacturing was
acquired by AMRI in July 2014.
About AMRI
Albany Molecular Research Inc. (AMRI) is a
global contract research and manufacturing organization that has
been working with the Life Sciences industry to improve patient
outcomes and the quality of life for more than two decades. With
locations in North America,
Europe and Asia, our key business segments include
Discovery and Development Services (DDS), Active Pharmaceutical
Ingredients (API), and Drug Product Manufacturing. Our DDS segment
provides comprehensive services from hit identification to IND,
including expertise with diverse chemistry, library design and
synthesis, in vitro biology and pharmacology, drug
metabolism and pharmacokinetics, as well as natural products. API
Manufacturing supports the chemical development and cGMP
manufacture of complex API, including potent, controlled
substances, biologics, peptides, steroids, and cytotoxic compounds.
Drug Product Manufacturing supports pre-clinical through commercial
scale production of complex liquid-filled and lyophilized
parenteral formulations. For more information about AMRI, please
visit our website at www.amriglobal.com or follow us on Twitter
(@amriglobal).
About AMRI Drug Product Manufacturing
Albany Molecular
Research Inc.'s (AMRI) Drug Product Manufacturing business supports
the clinical formulation development and cGMP aseptic formulation
and filling of complex Active Pharmaceutical Ingredients (API),
including potent, controlled substances, biologics, peptides,
steroids, and cytotoxic compounds. On the Drug Product side, we
have expertise with supporting pre-clinical through commercial
scale production of complex liquid-filled and lyophilized
parenteral formulations. We specialize in vial and pre-filled
syringe manufacturing and have lyophilization capabilities for
vials. AMRI has the capability to perform small batch
manufacturing, but has the capacity to perform filling for larger
batches to support Phase III, registration batches and
commercial.
SOURCE AMRI