Navigation Links
FDA Inspects Hovione's Technology Transfer Center in New Jersey

LOURES, Portugal, October 29 /PRNewswire/ -- Hovione's Technology Transfer Center (TTC) in New Jersey has just passed successfully a pre-approval inspection by FDA.

The inspection was carried out by Ms. Joy R. Kozlowski-Klena Compliance Officer at the US FDA Center for Drug Evaluation and Research (CDER) and lasted 3 days, starting on October 9th and concluded on the 12th. No form 483 was issued. At the closing meeting, the inspector had several positive comments on our systems and indicated she would be recommending the approval of the site. This inspection covered the TTC's first commercial product - a high potency small molecule API for an injectable formulation. The NDA was filed last May and approval is expected in Q1 2008, with a launch foreseen later that year. Mr. Dave Hoffman, President of the US Operations said "This is an exciting milestone for our New Jersey Technology Transfer Center. This successful FDA compliance inspection gives a green light to an NDA compound - we look forward to further expanding small scale commercial manufacturing opportunities at our NJ site".

Hovione plants have been object of 15 FDA inspections. This inspection is the first at the New Jersey since it started to operate as an R&D facility in September 2002. In the Establishment Inspection Report issued by Ms. Joy R. Kozlowski-Klena it is stated "This inspection covered the NDA under evaluation, as well as limited GMP coverage of systems in place at this time, including Quality, Laboratory, Production, Facilities and Equipment. The inspection did not reveal any significant deficiencies."

The TTC site serves as Headquarters for Hovione's US Operations, and consist of process chemistry R&D labs, cGMP kilo and scale-up labs and a cGMP pilot plant. The TTC is also the home of Hovione's commercial offices. The TTC offers Hovione's US based customers' process development and scale-up services, along with quality control/assurance and regulatory support. The cGMP facility is designed to prepare small quantity NCE's to support customer's pre-clinical and early-phase clinical development, demonstrating the customer's processes locally before transferring them to Hovione's full scale manufacturing plants, in Europe and Asia.

Hovione is an international group specializing in the development and compliant production of active pharmaceutical ingredients (APIs), serving exclusively the pharmaceutical industry. With a 48-year track record in process development, quality standard and advanced particle design technologies, Hovione offers APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. With FDA inspected plants in Europe, Far East and New Jersey, Hovione is committed to the highest levels of service and quality. Specializing in complex chemistry, Hovione offers services related to the development and manufacture of either a new chemical entity (NCE) for an exclusive contract manufacturing partner or an existing API for an off-patent product.

For further information about Hovione, please visit the Hovione site at


Corporate Communications,

Isabel Pina,



SOURCE Hovione
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Vedic vibration technology- the new cure for arthritis
2. Biotechnology industry expected to grow into a three billion dollar industry by 2002
3. Biotechnology on the lead
4. New Technology In MRI Scan Help Test Brain Cancer Therapy
5. New technology to decipher neural connections dealing with heredity and environment
6. Emergence Of New Gene Scanning Technology In Disease Research
7. CoQ10 bioavailability increased by Nanotechnology
8. Developing a new vaccine using a new technology
9. Scientists Develop New Technology To Find About Human Ancestors’ Teet
10. T-waves to sweep over imaging technology
11. Nanotechnology Revolution To Be Spearheaded By European Union
Post Your Comments:
(Date:6/27/2016)... ... 2016 , ... The OSHA Training Center at Chabot-Las ... headquartered in Northern California, has issued an important reminder to employers to prevent ... Employers with workers exposed to high temperatures should establish a complete heat illness ...
(Date:6/27/2016)... (PRWEB) , ... June 27, 2016 , ... "FCPX editors ... customizable inside of Final Cut Pro X," said Christina Austin - CEO of Pixel ... style. Final Cut Pro X users can now reveal the media of ...
(Date:6/27/2016)... ... June 27, 2016 , ... TherapySites, the leading ... with Tennessee Counseling Association. This new relationship allows TherapySites to continue ... Association, adding exclusive benefits and promotional offers. , "TCA is extremely excited about ...
(Date:6/27/2016)... ... June 27, 2016 , ... ePAY ... partnership with Connance, a healthcare industry leader providing predictive analytics to optimize ... combine to provide health systems, hospitals and ambulatory surgical centers with dramatic ...
(Date:6/27/2016)... ... June 27, 2016 , ... A revolution is underway. ... ambulance transport experience for the millions of people who require these medical transport ... taxi industry through the use of technology. Now, SmartEMS has put forth an ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... 26, 2016 One of Australia,s ... formation of a new biotechnology company, Noxopharm Limited [ABN 50 608 ... IPO and to list on the ASX. Noxopharm is ... to enter a Phase 1 clinical study later this year. ... one of the biggest problems facing cancer patients - the ability ...
(Date:6/26/2016)... , June 27, 2016 Jazz Pharmaceuticals ... waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of ... acquisition of Celator Pharmaceuticals, Inc. ("Celator"; Nasdaq: ... p.m. (Eastern Daylight Time). As previously announced ... into a definitive merger agreement under which Jazz Pharmaceuticals ...
(Date:6/26/2016)... , June 27, 2016  VMS Rehab Systems, Inc. ... will take whatever measures required to build a strong ... which is currently listed on the OTC Markets-pink current ... Chairman and CEO, "We are seeing an anomaly in ... understand, not only by the Company, but shareholders and ...
Breaking Medicine Technology: