Navigation Links
Cambrex Manufacturing Facility Completes Successful US FDA Inspection
Date:12/16/2013

EAST RUTHERFORD, N.J., Dec. 16, 2013 /PRNewswire/ -- Cambrex Corporation (NYSE: CBM, "Cambrex") announced that the US Food and Drug Administration (FDA) completed an inspection of Cambrex's active pharmaceutical ingredient (API) manufacturing facility in Charles City, Iowa. The inspection found the site to be compliant with the principles and guidelines of Good Manufacturing Practice (GMP) and no Form 483 observations were issued. The US FDA authorities inspected the facility from July 31 to August 2, 2013.

Joe Nettleton, Vice President Operations and Charles City Site Director commented, "We are very pleased with the results of this latest FDA inspection, which further strengthens our track record of outstanding regulatory compliance. We commit significant resources and work diligently to maintain high quality standards and continuously improve quality platforms within Cambrex."

The entire facility and the quality systems used for the manufacture and release of APIs and food grade products were subject to a detailed compliance inspection. This follows successful inspections at Charles City made previously by the US FDA in March 2010 and February 2012, neither of which resulted in any issued 483 observations, the Korean FDA in January 2012 and the Medicines and Healthcare Products Regulatory Agency (MHRA) of the UK October 2011, after which a GMP certificate for a drug product intermediate was issued.     

About Cambrex
Cambrex Corporation is an innovative life sciences company that provides products, services and technologies to accelerate the development and commercialization of small molecule therapeutics.  We offer APIs, advanced intermediates and enhanced drug delivery products for branded and generic pharmaceuticals. Our development and manufacturing capabilities include enzymatic biotransformations, high potency APIs, high energy chemical synthesis, controlled substances and formulation of finished dosage form products. For more information, please visit http://www.cambrex.com


'/>"/>
SOURCE Cambrex Corporation
Copyright©2012 PR Newswire.
All rights reserved

Related biology technology :

1. Cambrex to Present at Oppenheimer 24th Annual Healthcare Conference
2. Cambrex To Present At UBS Global Healthcare Conference
3. Cambrex Reschedules Third Quarter 2012 Financial Results and Earnings Call Date to November 5, 2012
4. Cambrex Reports Second Quarter 2012 Results
5. Cambrex to Announce Fourth Quarter 2011 Financial Results on February 6, 2012
6. InstantGMP Completes Updates to v2.03 of their Manufacturing Execution System with Electronic Batch Records
7. New In-Depth Report on Demand and Supply for Contract Manufacturing of Injectable Drugs Through 2019
8. Genesis Herb Company Selects InstantGMP as their Manufacturing Execution System with Electronic Batch Records
9. Pfenex Inc. Awards Paragon Bioservices a Contract for cGMP Manufacturing of its Recombinant Protective Antigen (rPA), for Phase 1 Clinical Trial of its Anthrax Vaccine
10. ACell Expands Indiana Manufacturing Facility to Support Growth
11. Samsung BioLogics Signs a Strategic Manufacturing Partnership with Roche
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/13/2017)... ... September 13, 2017 , ... ... life sciences industry to improve patient outcomes and quality of life for more ... has been named a US expert to the International Standards Organization/Technical Committee ...
(Date:9/12/2017)... ... 12, 2017 , ... PhysIQ, a Chicago-based company that provides ... monitoring and clinical trial support, earned DPharm Idol 2017 honors at the 7th ... Launched in 2005, PhysIQ leverages artificial intelligence (AI) to empower digital health. The ...
(Date:9/12/2017)... ... September 12, 2017 , ... ... their latest product LabCODE™, a novel Lab Information Management System (LIMS) built ... for Biobanking, Pharmacokinetics, Pharmacogenetics, Next Generation Sequencing, Flow Cytometry, Pathology, and much ...
(Date:9/12/2017)... ... 2017 , ... Soybean researchers seeking funding from the ... October 15, prior to completing a full grant application. , “The pre-proposal process ... and to encourage researchers to further develop ones that might need more work,” ...
Breaking Biology Technology:
(Date:4/11/2017)... April 11, 2017 Crossmatch®, a globally-recognized ... solutions, today announced that it has been awarded ... Projects Activity (IARPA) to develop next-generation Presentation Attack ... "Innovation has been a driving force within ... will allow us to innovate and develop new ...
(Date:4/5/2017)... April 5, 2017  The Allen Institute for Cell ... Explorer: a one-of-a-kind portal and dynamic digital window into ... data, the first application of deep learning to create ... cell lines and a growing suite of powerful tools. ... these and future publicly available resources created and shared ...
(Date:3/30/2017)... ANGELES , March 30, 2017  On April ... Hack the Genome hackathon at Microsoft,s ... exciting two-day competition will focus on developing health and ... Hack the Genome is the ... been tremendous. The world,s largest companies in the genomics, ...
Breaking Biology News(10 mins):