Navigation Links
FDA Inspects Hovione's Technology Transfer Center in New Jersey
Date:10/29/2007

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 http://www.hovione.com

Contacts:

Corporate Communications,

Isabel Pina,

+351-21-982-9362,

e-mail: hello@hovione.com


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:5/3/2016)... ... May 03, 2016 , ... Elizabeth Murray has always loved ... join her with one on her shoulder and one on her arm. But she ... because of years of mitral valve prolapse. , The valves of the heart wouldn’t ...
(Date:5/3/2016)... ... May 03, 2016 , ... University of the People, ... launch of its Associates and Bachelor's degrees in Health Studies. Leading figures are ... Dr. Torsten N. Wiesel; Chairman and CEO of Fortune 500® company Henry Schein, ...
(Date:5/3/2016)... ... ... Boston Children’s Hospital today announced its new pediatric Simulation (SIM) Center — ... procedures in an environment that looks and feels real. , Located in the heart ... “hackers” to develop and test new devices or software platforms and see how they ...
(Date:5/3/2016)... ... ... Park Cities Pet Sitter has openings for both full-time and part-time ... 75219, 75220, 75225, 75229, 75230, 75231 and 75235 zip codes. These zip codes ... and Park Cities areas of the Metroplex. Candidates must love animals, have attention ...
(Date:5/3/2016)... ... May 03, 2016 , ... ... industry, announced today that Legacy Health is expanding its use of Intrigma’s cloud-based ... a highly successful initial proof of concept. The Portland, Oregon based health system ...
Breaking Medicine News(10 mins):
(Date:4/29/2016)... April 29, 2016 ... Financier Sanofi, leader mondial ... ses résultats pour le premier trimestre ... Jérôme Contamine, commente les résultats du ... perspectives pour le reste de l,année. ...
(Date:4/28/2016)... 2016  While Abbott,s announced purchase of St. ... repair and stent business, healthcare research firm Kalorama ... firmly into patient monitoring.  Kalorama said that patient ... areas, with double-digit growth expected the next 5 ... Remote Patient Monitoring . Abbott Laboratories agreed ...
(Date:4/28/2016)... April 28, 2016  The blood testing market in ... according to Kalorama Information and The Freedonia Group in ... nucleic acid testing.  The healthcare research firm said that ... developing blood collection stations and in improving testing at ... Information,s report, Blood Testing Market in China ...
Breaking Medicine Technology: