Hikma Pharmaceuticals Plc Hikma Launches 503B Sterile Compounding Business (9016X)
January 10 2022 - 2:00AM
UK Regulatory
TIDMHIK
RNS Number : 9016X
Hikma Pharmaceuticals Plc
10 January 2022
Hikma Launches New 503B Sterile Compounding Business
Builds on leading position in US sterile injectables market
Brings company's proven experience in quality and reliability to
compounding
London, UK - 10 January 2022 - Hikma Pharmaceuticals PLC
("Hikma"), the multinational pharmaceutical company, announces the
launch of Hikma 503B - a new outsourced sterile compounding
business focused on providing high quality, ready-to-administer
injectable medications that are customized to the specific needs of
patients in the United States.
Sterile compounding - the process of combining, mixing, or
altering ingredients to create medications in ready-to-administer
formats tailored to the needs of health care providers - is an
important specialized approach to drug manufacturing that serves a
critical role in patient care. Hospital pharmacists, physicians and
nurses increasingly need these medicines, resulting in a growing US
market for outsourced compounded sterile injectable medications
that is now estimated to exceed $2 billion annually.
The launch of Hikma 503B builds on the company's expertise and
position as a leading supplier of injectable medicines to US
hospitals with a strong reputation for quality and reliability.
Today, Hikma is the second-largest supplier by volume of generic
injectables to US hospitals, and one out of every six generic
injectable medicines used by US hospitals is a Hikma product. The
company's extensive supplier relationships and access to raw
materials also provide a unique point of differentiation to
existing players in the outsourced sterile compounding space.
"Hikma 503B is a natural extension of our injectables business,
building on our strong relationships with US hospitals and
excellent quality manufacturing protocols to provide urgently
needed product offerings to patients and health care providers in
the US," said Riad Mishlawi, President, Injectables, Hikma. "There
is substantial demand for outsourced sterile compounded medicines
among the thousands of hospitals we currently serve, representing a
large opportunity to meet a growing and not fully met need within
the US health care system. Hikma 503B is uniquely positioned to
bring pharmaceutical manufacturing standards to the space, which we
believe will establish us as a significant player in the market
over time."
Hikma 503B will operate principally out of a 65,000 sq. ft.,
purpose-built facility in Dayton, NJ, that was acquired by Hikma in
2020. Hikma has greatly enhanced the Dayton site to create a
state-of-the-art sterile outsourced compounding and distribution
facility in line with the company's high standards of quality,
adding automation and segregation for enhanced productivity while
minimizing risks.
"We are applying Hikma's expertise, talent, and engrained
commitment to quality to ensure our 503B business meets CGMP
standards, which is what the FDA requires of 503B outsourcing
facilities," said Joel Rosenstack, Chief Commercial Officer, US
Injectables, Hikma. "Our 503B business is powered by the same team
and philosophy that is behind Hikma's reputation for quality
medicines."
Hikma 503B is registering for state licenses across the US and
expects to be operating nationwide by the end of 2022.
- Ends -
Enquiries
Hikma Pharmaceuticals PLC
Investors:
Susan Ringdal +44 (0)20 7399 2760/ +44 7776
EVP, Strategic Planning and Global Affairs 477050
uk-investors@hikma.uk.com
Media:
Teneo (UK media)
Charles Armitstead +44 (0)7703 330 269
US Media
Steve Weiss +1 732 788 8279
David Belian +1 848 254 4875
US Communications and Public Affairs uscommunications@hikma.com
About Hikma
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated BBB-/stable
S&P and BBB-/stable Fitch)
Hikma helps put better health within reach every day for
millions of people around the world. For more than 40 years, we've
been creating high-quality medicines and making them accessible to
the people who need them. Headquartered in the UK, we are a global
company with a local presence across the United States (US), the
Middle East and North Africa (MENA) and Europe, and we use our
unique insight and expertise to transform cutting-edge science into
innovative solutions that transform people's lives. We're committed
to our customers, and the people they care for, and by thinking
creatively and acting practically, we provide them with a broad
range of branded and non-branded generic medicines. Together, our
8,600 colleagues are helping to shape a healthier world that
enriches all our communities. We are a leading licensing partner,
and through our venture capital arm, are helping bring innovative
health technologies to people around the world. For more
information, please visit: www.hikma.com
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