ALBUQUERQUE, N.M., Nov. 20, 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.
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.