Navigation Links
Successful FDA Inspection at Hovione's API Manufacturing Plant in Cork, Ireland

LISBON, Portugal, July 31, 2014 /PRNewswire/ --

Hovione today announced that its API plant in Cork, Ireland has successfully passed a pre-approval inspection by the US Food and Drug Administration (FDA).

The inspection, carried out by the FDA Consumer Safety Officer, Ms. Britanny Terhar, lasted 5 days as initially planned, started on 21st July and concluded on the 25th. The inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP) and no Form 483 observations were issued. At the closing meeting the inspector informed that she was satisfied with what she had seen and complimented Hovione on its GMP system, inspection organization and the knowledge of its team members.

On the outcome of the inspection, Luisa Paulo, Hovione's Compliance Director, said: "The pre-approval inspection was triggered by a client NDA filing, it also covered the manufacturing of a commercial NDA and a generic antibiotic, doxycycline. It is an extremely satisfying result for our team and for our customers. The Hovione Team members have again demonstrated their commitment and ability to meet the highest quality standards in the manufacturing of APIs and pre-formulated drug products."

Jim Harvey, Hovione's General Manager at the Cork site, said: "We are very proud of the result achieved during this flawless FDA inspection. I am very satisfied that the FDA inspector reported no observations and I want to congratulate the entire team. This is another important step for our site in Cork as it confirms our ability to comply with high engineering, manufacturing and quality standards across all of the Hovione sites."

About Hovione. Hovione is an international company with over 50 years' experience in Active Pharmaceutical Ingredient development and compliant manufacture. With four FDA inspected sites in the U.S., China, Ireland, and Portugal, the company focuses on the most demanding customers, in the most regulated markets. The company also offers branded pharmaceutical customers services for the development and compliant manufacture of innovative new drugs, is able to support highly potent compounds and offers all customers proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering such a broad range of services.

For more information about Hovione, please visit or contact Marketing & Communication, Isabel Pina, +351-21-982-9362, e-mail:

SOURCE Hovione
Copyright©2014 PR Newswire.
All rights reserved

Related medicine technology :

1. STAAR Surgical Celebrates Over 300,000 Successful Visian® ICL Implants at ASCRS Congress
2. Report Presents a Framework for Successful New Oncology Product Launches in the Pharmaceutical Sector
3. Novelos Therapeutics Announces Successful Completion of First Cohort In Lung Cancer Trial With I-124-CLR1404 (LIGHT) Cancer-Targeted PET Imaging Agent at UW Carbone Cancer Center
4. Lilly Applauds Law Enforcement Officials for their Successful Investigation and Recovery of Pharmaceuticals Stolen from Connecticut Distribution Center
5. Adamas Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA for Arimenda™
6. Novelos Therapeutics Successfully Completes First Cohort In Phase 1b Solid Tumor Trial With I-131-CLR1404 (HOT) Cancer-Targeted Molecular Radiotherapeutic
7. AXIOS™ Stent and Delivery System Study Demonstrates Successful Treatment of Pancreatic Pseudocysts and Acute Cholecystitis
8. Pharmos Corporation Announces Successful Completion Of Proof-of-concept Clinical Trial Of Levotofisopam For The Treatment Of Gout
9. Acuo Technologies Grows European Business and Achieves Successful Connectathon Results in Bern, Switzerland
10. CMC Biologics Achieves Successful Pre-Approval European GMP Inspection by MHRA for Commercial Manufacturing
11. Concord Medical Announces its Successful Closing of the Acquisition of 52% Ownership in Changan Hospital and Provides Guidance for Financial Results of the Second Quarter of 2012
Post Your Comments:
(Date:11/26/2015)... Research and Markets ( ) has announced the addition ... 2019 - Rise in Cardiac Disorders and Growing Awareness among ... offering. Boston scientific and ... and others. --> The market is dominated ... scientific and others. Asia ...
(Date:11/26/2015)... , Nov. 26, 2015 Research ... addition of the "2016 Future Horizons and ... (TDM) Market: Supplier Shares, Country Segment Forecasts, Competitive ... --> --> ... analysis of the Japanese therapeutic drug monitoring market, ...
(Date:11/26/2015)... DUBLIN , November 26, 2015 ... has announced the addition of the  ... in the Global Cell Surface Testing ... Opportunities" report to their offering.  ... the addition of the  "2016 Future ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... 2015 , ... The men and women on this list ... the country. They have overseen financial turnarounds, shown commitment to their community through ... as a whole through their advocacy and professional efforts. , Becker's Hospital Review ...
(Date:11/27/2015)... San Francisco, California (PRWEB) , ... November 27, 2015 , ... ... 1969 Janis Joplin Ann Arbor Michigan boxing style concert posters. This is one of ... 1969 at the Canterbury House at the University of Michigan in Ann Arbor. The ...
(Date:11/26/2015)... ... 2015 , ... Patients at Serenity Point Recovery, a holistic ... Thanksgiving Day to share the things that they are most grateful for today. ... channel, patients displayed what they wrote on index cards, describing the things that ...
(Date:11/26/2015)... ... November 26, 2015 , ... CognisantMD and Cambridge ... imaging in the Waterloo region. Using the Ocean Platform, family physicians can now ... their electronic medical record (EMR) without the need for redundant patient entry or ...
(Date:11/26/2015)... ... November 26, 2015 , ... The Catalent ... and the need to integrate dose form selection in early phase drug development. ... membership organization supporting and bringing together the UK’s emerging life sciences companies, corporate ...
Breaking Medicine News(10 mins):