Navigation Links
Successful FDA Inspection at Hovione's API Manufacturing Plant in Cork, Ireland
Date:7/31/2014

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 http://www.hovione.com or contact Marketing & Communication, Isabel Pina, +351-21-982-9362, e-mail: ipina@hovione.com



'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:7/21/2017)... SPRING, Md. and RESEARCH TRIANGLE ... United Therapeutics Corporation (NASDAQ: UTHR ) announced ... financial results before the market opens on Thursday, July ... Therapeutics will host a teleconference on Thursday, July 27, ... accessible by dialing 1-877-351-5881, with international callers dialing 1-970-315-0533.  ...
(Date:7/19/2017)... , July 19, 2017  Mako Medical Laboratories partnered ... the Military Family Assistance Fund (MFA) to bring 140 ... to visit with their families one last time before ... coordinate the travel and logistics needed for these soldiers. ... soldiers and their families. We just wish we could ...
(Date:7/14/2017)... , July 13, 2017 It should come ... States is in the midst of a crippling ... , since 1999, the number of overdose deaths from opiate-based ... in over half a million dead from 2001 to 2015". ... oxycodone, and hydrocodone has similarly quadrupled, drawing a compelling link ...
Breaking Medicine Technology:
(Date:7/21/2017)... (PRWEB) , ... July 21, 2017 , ... ... management assistance and financial planning services to families and business owners in northern ... event that promises to provide support to area adults with developmental challenges. , ...
(Date:7/21/2017)... ... July 21, 2017 , ... Adolfson & ... and improve the Ramsey County Medical Examiners Facility located in Saint Paul, Minn. ... million project is scheduled to start in late 2017/early 2018. , Staffed ...
(Date:7/21/2017)... ... July 21, 2017 , ... ... Theater of Witness , was awarded a $300,000 grant from The Pew ... fosters empathy, comfort with ambiguity and the recognition of one’s own limits among ...
(Date:7/21/2017)... , ... July 21, 2017 , ... Bernard R. Bach, ... President of the American Orthopaedic Society of Sports Medicine (AOSSM) , received the ... the AOSSM Annual Meeting in Toronto, Canada. This prestigious award is given annually to ...
(Date:7/21/2017)... , ... July 21, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House ... use of violence and aggression to solve problems and pleads with world leaders to be ... armed forces do not bring peace. He says there is a peaceful and positive way ...
Breaking Medicine News(10 mins):