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JHP Pharmaceuticals To Produce Supplies of Biologic
Drug Product For Late-Phase Clinical Trials
PARSIPPANY, NJ April 17, 2013 -- JHP
Pharmaceuticals, a leading provider of global
contract manufacturing services for sterile products
has entered into an agreement with an undisclosed
biotechnology company to produce clinical supplies
of a biologic for late-phase clinical trials.
JHP’s cGMP compliance history was a critical factor in the selection
process. Stuart Hinchen, CEO stated, “Our record of
cGMP compliance, driven by experienced Quality and
Regulatory Teams continues to be one of the key
reasons customers choose JHP. Additionally, both new
and established customers recognize our approach to
ongoing investment in people and facilities. As an
example, last year we broke ground on a new $10
million, 40,000 sq. ft. laboratory that will house
QC Chemistry and Method Transfer, Sterility
Assurance and Stability. This type of investment
allows us to focus on customer needs, which results
in sustainable sales growth.”
Hinchen noted, “Our use of disposable product contact equipment is
another leading factor in the selection process.
JHP’s strategic use of disposables provides our
customers with manufacturing process efficiencies
that result in reduced cycle time."
JHP Pharmaceuticals’ Rochester, Michigan facility has over 25 years’
experience in contract manufacturing. Expertise in
seamlessly progressing from clinical batch
production to commercialization provides customers
with continuity of supply and program efficiencies.
A comprehensive suite of services including
Regulatory, Analytical Methods Development, Package
Engineering, Stability Testing and Validation also
support contract manufacturing customers. JHP has
successfully supported launches of several products
in US and international markets and manufactures
products for sale in 86 countries.
About JHP Pharmaceuticals, LLC
JHP Pharmaceuticals, headquartered in New
Jersey, provides contract manufacturing of sterile products including biologics,
small molecule, controlled substances, vaccines, ophthalmics, otics and
antibiotics for large and small pharmaceutical and biotech organizations.
JHP’s sterile manufacturing facility, located in Rochester Michigan sits
on over 80 acres of land and includes a 171,000 sq. ft. production building and
warehouse. The production facility utilizes three high-speed filling lines, a
clinical filling line and four lyophilizers. The site also includes separate
facilities for chemistry, sterility testing, and analytical methods development.
JHP has the capability to manufacture small-scale clinical through
large-scale commercial products. JHP employs more than 380 staff in the USA in
its manufacturing, product development, regulatory, sales and marketing and
corporate areas. For more information, please visit
www.jhppharma.com.
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Additional Press Releases |
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04/17/13 |
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JHP Pharmaceuticals To Produce Supplies of Biologic Drug Product For Late-Phase Clinical Trials |
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09/19/12 |
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JHP Pharmaceuticals To Produce
Lyophilized Biologic for International
Late-Phase Clinical Trials
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Webpage
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06/05/12 |
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JHP Pharmaceuticals to Produce
Clinical and Commercial Supply of an
Innovative Injectable |
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02/29/12 |
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JHP Pharmaceuticals Adds Second Product To Multi-Year Contract Manufacturing Agreement |
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07/25/11 |
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JHP Pharmaceuticals to Produce
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07/06/11 |
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JHP Pharmaceuticals Enters Agreement
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07/05/11 |
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JHP Pharmaceuticals Launches New
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06/24/11 |
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JHP Pharmaceuticals Announces Chief
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03/28/11 |
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JHP Pharmaceuticals Announces
Multi-Year Contract Manufacturing
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02/24/11 |
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JHP Pharmaceuticals Enters Another Multi-Year
Contract Manufacturing Agreement |
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01/27/11 |
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JHP Pharmaceuticals & Putney Inc. Announce
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06/29/10 |
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JHP Pharmaceuticals Announces Multi-Year
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05/10/10 |
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JHP Pharmaceuticals Announces Successful
Completion of FDA and EMEA GMP Audits |
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09/28/09 |
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JHP Announces FDA
Approval for Dantrium
IV, rapidly mixing in 20
seconds
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08/20/08 |
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JHP Pharmaceuticals &
SpePharm complete
purchaseof Dantrium®
(dantrolene sodium)
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07/16/07 |
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King Pharmaceuticals Completes Sale
Of Rochester, Michigan Manufacturing
Facility To JHP Pharmaceuticals |
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