Navigation Links
Lyophilization Services of New England Completes FDA Inspection
Date:1/8/2014

MANCHESTER, N.H., Jan. 8, 2014 /PRNewswire/ -- Lyophilization Services of New England (LSNE), a New Hampshire based contract manufacturing organization is pleased to announce that the Food and Drug Administration (FDA) recently completed an inspection of their Manchester manufacturing facility.  This is the sixth successful inspection of the site, which is currently functioning as a multiproduct medical device manufacturing facility.  The November 2013 inspection was a combination FDA general GMP and Pre-approval inspection.  The inspection resulted in no Form 483 being issued, as there were no observations noted by FDA.

Matthew Halvorsen, President and Chief Executive Officer of LSNE stated, "We are very pleased with the result of the latest FDA inspection, which adds to our successful regulatory history.  LSNE is committed to maintaining the highest level of quality across our three manufacturing sites so that we can remain a reliable partner to our clients."

This FDA inspection follows a successful MHRA inspection of the LSNE 25 Commerce Drive, Bedford NH contract pharmaceutical manufacturing facility in which LSNE received a Certificate of GMP Compliance from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to manufacture aseptic lyophilized drug products for use in the European Union.

About LSNE Contract Manufacturing

LSNE Contract Manufacturing is a privately held company with three GMP facilities located in New England.   LSNE has been providing contract lyophilization services to the pharmaceutical, biotechnology and medical device industries since 1997, specializing in a wide range of services including cycle development, cGMP fill/finish, and lyophilization.  Through the thoughtful integration of three processing facilities, qualified staffing, and an extensive manufacturing history, LSNE is strategically positioned to provide uninterrupted manufacturing for clinical through commercial supply for medical device and pharmaceuticals to a multi-national market.

Media Contact
Christine Palus
Vice President of Sales & Marketing
(603) 668-5763
info@lyophilization.com
www.lyophilization.com


'/>"/>
SOURCE Lyophilization Services of New England
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. ANI Pharmaceuticals Enters Development Agreement for Generic Drug Product with Sterling Pharmaceutical Services
2. Improving the Quality and Effectiveness of Marketing Services Groups in an Environment Characterized by Globalization and Shrinking Resources
3. inviCRO hires Stefan Linehan as Director of Ex Vivo Research & Imaging Services
4. Clayton, Dubilier & Rice to Invest in PharMEDium, Nations Leading Provider of Sterile Compounding Services to Hospital Pharmacies
5. Smithers Quality Assessments Expands Certification Services to Include Pharmaceuticals Industry
6. Cord Blood Banking Services Market is Expected to Reach USD 15.2 Billion Globally in 2019: Transparency Market Research
7. Indegene launches a complete range of MCM services specifically focused on integrated brand-product promotions.
8. Genpact and AstraZeneca Extend Finance and Accounting Services Agreement
9. Liquidity Services Delivers Surplus Asset Solutions in Support of Hoffmann-La Roches Consolidation Initiative
10. Numotion Acquires the Custom Mobility Division of Barnes Healthcare Services
11. PBL Assay Science announces ultra-sensitive assay services to measure biomolecules in human serum or plasma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... -- Research and Markets has announced ... Applications, Technologies, Forecasts" report to their offering. ... Smart Skin, Structural Health Monitoring, Composite Smart Structures, ... involves electronic and/or electrical components and circuits that ... such as vehicle bodies or conformally placed upon ...
(Date:6/24/2016)... Research and Markets has announced the ... Tests" report to their offering. ... The World Market for Companion Diagnostics covers the ... analysis in the report includes the following: ... Kits) by Region (N. America, EU, ROW), 2015-2020 , ...
(Date:6/24/2016)... Tenn. , June 24, 2016  Arkis ... providing less invasive and more durable cerebrospinal fluid ... in funding.  The Series-A funding is led by ... Lighthouse Fund, and other private investors.  Arkis, new ... neurosurgical instrumentation and the market release of its ...
Breaking Medicine Technology:
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... Pixel Film ... Pro X. , "Film editors can give their videos a whole new perspective by ... Austin - CEO of Pixel Film Studios. , ProSlice Levels contains over 30 ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery ... of Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. , ... for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin ... injury. Recently, he has implemented orthobiologic procedures as a method for treating his ... of the first doctors to perform the treatment. Orthobiologics are substances that orthopaedic ...
(Date:6/24/2016)... ... 2016 , ... June 19, 2016 is World Sickle Cell Observance Day. In ... benefits of holistic treatments, Serenity Recovery Center of Marne, Michigan, has issued ... Sickle Cell Disease (SCD) is a disorder of the red blood cells, which can ...
(Date:6/24/2016)... ... 2016 , ... Comfort Keepers® of San Diego, CA is excited to announce ... program to drive cancer patients to and from their cancer treatments. Comfort Keepers ... of life and ongoing independence. Getting to and from medical treatments is one ...
Breaking Medicine News(10 mins):