ALBANY, N.Y., Jan. 11, 2016 /PRNewswire/ -- AMRI (NASDAQ:
AMRI) announced that Docetaxel Injection (non-alcohol formula) has
been approved for commercial manufacture at its Burlington, Mass. aseptic fill-and-finish
facility following U.S. Food and Drug Administration's (FDA)
pre-approval inspection for this drug product.
Eagle Pharmaceuticals, Inc., which entered into an exclusive
licensing agreement with Teikoku Pharma USA Inc. in October
2015 to market, sell and distribute Docetaxel Injection in
the United States, announced the
FDA's U.S. approval of Docetaxel Injection in December 2015. Docetaxel Injection is the first
alcohol-free formulation approved in the
United States for the treatment of breast cancer, non-small
cell lung cancer, prostate cancer, gastric adenocarcinoma, and head
and neck cancer.
William S. Marth, President and
CEO, of AMRI, said, "AMRI is excited to have been able to work with
Eagle to meet this important unmet medical need in the market. The
Docetaxel non-alcohol drug product attributes, as well as the
manufacturing process itself, are considered to be both unique and
challenging with the process containing several critical process
control parameters. This commercial scale process has been
successfully developed and validated at the AMRI Burlington
facility."
AMRI provides integrated development, formulation, and
commercial parenteral solutions, which includes pre-formulation,
formulation and process development; cGMP injectable formulation
development and clinical drug product; and late phase and
commercial parenteral manufacturing. AMRI's Burlington, Mass. facility is expertly
equipped to provide formulation development, cGMP manufacturing and
sterile filling of parenteral drugs – including both small molecule
drug products as well as biologicals – using various specialized
technologies.
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 (DPM). 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 supports the
chemical development and cGMP manufacture of complex API, including
potent, controlled substances, biologics, peptides, steroids,
hormones, cytotoxic compounds and sterile API. DPM supports
development through commercial scale production of complex
liquid-filled and lyophilized parenterals, sterile suspensions and
ophthalmic formulations. For more information about AMRI, please
visit our website at www.amriglobal.com or follow us on Twitter
(@amriglobal).
About Eagle Pharmaceuticals, Inc.
Eagle is a specialty pharmaceutical company focused on
developing and commercializing injectable products that address the
shortcomings, as identified by physicians, pharmacists and other
stakeholders, of existing commercially successful injectable
products. Eagle's strategy is to utilize the FDA's 505(b)(2)
regulatory pathway. Additional information is available on the
company's website at www.eagleus.com.
Forward-Looking Statements
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
that involve risks and uncertainties. These statements
include, but are not limited to, statements regarding expected
future performance of AMRI, statements regarding U.S. Food and Drug
Administration approval, and statements made by AMRI's President
and CEO. Readers should not place undue reliance on our
forward-looking statements. AMRI's actual results may differ
materially from such forward-looking statements as a result of
numerous factors, some of which AMRI may not be able to predict and
may not be within AMRI's control. Factors that could cause
differences include, but are not limited to, decisions by the FDA;
trends in pharmaceutical and biotechnology companies' outsourcing
of chemical research and development, including softness in these
markets; the risk that clients may terminate or reduce demand under
any strategic or multi-year deal; AMRI's ability to effectively
maintain compliance with applicable FDA and DEA regulations; the
ability of AMRI's strategic investments and acquisitions to perform
as expected, as well as those risks discussed in AMRI's
Annual Report on Form 10-K for the fiscal year ended December 31, 2014 as filed with the Securities
and Exchange Commission on March 16,
2015, and AMRI's other SEC filings.
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SOURCE AMRI