Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Almac Launches US Commercial Packaging Operations in Audubon

Published: Monday, May 20, 2013
Last Updated: Monday, May 20, 2013
Bookmark and Share
Company also announces launch of new client partnership.

Almac has announced the successful inspection of its new US Commercial Packaging operations located in Audubon, PA by the Food and Drug Administration (FDA).

The inspection took place on the 9th and 10th January 2013 from which the regulatory body concluded that the Pennsylvania based site is fully compliant with Good Manufacturing Practices, with no 483 issued.

Commenting on the inspection, Ian Markwell, Vice President of Quality, said: “We are very pleased with the outcome of our inspection, as it marks the establishment of our US commercial packaging operations with FDA approval for bottle, blister, wallet and vial labeling/packaging.”

Jim McGibbon, US Director of Business Development explained “We are now able to meet the growing market demand for quality led, flexible commercial packaging solutions in the US. Now having been successfully inspected by the FDA, we are ready to commence operations for our first client.”

Almac’s first US commercial packaging client, a US-based diversified healthcare company, is an existing long term client partner of its UK operations for both formulation development and contract commercial manufacture services.

Initially Almac will supply three commercial products with bulk tablet and capsule manufacture taking place in Almac’s EMA and FDA approved commercial facility in the UK, with final bottle and blister packaging taking place in Audubon.

“This is a significant first contract for the Audubon facility filling in excess of 4M finished packs per annum, so it’s proving a busy start to the year!” added McGibbon.

Almac’s new FDA approved, US commercial packaging facility in Audubon, PA, offers flexible packaging solutions from primary packaging of solid oral dosage forms to customized secondary labelling and packaging of sterile biopharmaceutical products for both established US products and niche/orphan drug launches alike.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,200+ scientific posters on ePosters
  • More than 4,800+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Almac Group Launches US Serialisation Solution
Company has announced an expansion to its serialisation capabilities to include its US commercial packaging facility in partnership with Optel Vision.
Thursday, May 12, 2016
Almac Addresses Industry Demand for Multiparticulate Drug Products
Company is providing scalable fluid bed and encapsulation technologies to its global partners.
Friday, October 09, 2015
Almac Group Expands Asia Pacific Presence
Company opens new regional headquarters and clinical trial supply facility in Singapore.
Thursday, July 16, 2015
Novozymes Biopharma Announces Collaboration with Almac
Combined service offers drug development companies efficiencies in time and resource.
Tuesday, October 22, 2013
Almac Expands US & UK Commercial Facilities
Investments of over $20m enhance Almac’s commercial facilities on both sides of the Atlantic.
Tuesday, October 22, 2013
Almac Announces Further Expansion and 229 New Jobs
Dual expansion with completion of a new non-GMP drug development facility.
Monday, June 17, 2013
Almac Receives FDA Inspection Approval
Successful inspection of analytical facilities at Almac’s Craigavon Headquarters, Northern Ireland from the US FDA.
Thursday, February 21, 2013
Almac Doubles Drug Product Development Capacity with a New Non-GMP Facility
New facility offers clients greater flexibility and speed in formulation and process development.
Tuesday, January 15, 2013
Charlie Morris Appointed to Almac’s Clinical Technologies Executive Team
Mr. Morris joins Almac as Vice President of new products and services.
Thursday, December 13, 2012
Almac Concludes Commercial API Manufacturing Facility Expansion Plans
Almac’s expansion is near completion and will be operational by the end of the year.
Tuesday, October 09, 2012
Almac Expands UK Commercial Capacity
Acquisition of new Noack N 623 blister packaging line from Romaco.
Friday, October 05, 2012
Almac Installs Uhlmann Blister Line in New US Commercial Packaging Facility
Acquisition of a high-speed blister line in Audubon, PA.
Monday, July 02, 2012
Almac Introduces QP Facilitation Programme for Conducting Trials in the European Union
Programme vastly simplifies and expedites the QP release process.
Thursday, June 14, 2012
Almac Adds High-Speed Clinical Trial Blistering Equipment at US HQ
Almac acquires PharmaWorks TF3 machine to fulfil customer's needs by increasing blistering capacity.
Tuesday, May 15, 2012
Almac Strengthens Board with Appointment of New Financial Director
Kevin Stephens’ promotion to FD is set to further enhance the Group’s financial performance and programme for international growth.
Tuesday, April 10, 2012
Scientific News
Viable HIV Vaccine Confirmed by Study
HIV Study in macaques confirms clinically viable vaccine opening the way for future treatment in humans.
PREVAIL Treatment Trial for Men with Persistent Ebola Viral RNA
The six-month study will enroll 60 to 120 EVD survivors.
What Makes a Good Scientist?
It’s the journey, not just the destination that counts as a scientist when conducting research.
Investigational Malaria Vaccine Protects Healthy U.S. Adults
Researchers at NIH have found that the malaria vaccine protected a small number of healthy, malaria-naïve adults in the U.S. from infection for more than one year after immunization.
AACR 2016: Cancer Immunotherapy and Beyond
At this year's meeting there was a palpable buzz around subjects ranging from microbiomics to the tumor microenvironment and cancer vaccines, big data to in vitro and in vivo modeling and drug delivery (to name just a few).
New Database for Sharing MS Clinical Trial Data
A new database containing nearly 2500 patient records from the placebo arms of nine multiple sclerosis (MS) clinical trials is now available for research by qualified investigators.
Study Finds Factors That May Influence Influenza Vaccine Effectiveness
Researchers at NIH have suggested that the long-held approach to predicting seasonal influenza vaccine effectiveness may need to be revisited.
BMS’s Opdivo Clinical Trial Shows Promise
Safety profile of the combination regimen from CheckMate -069 was consistent with previously reported studies and adverse events were managed using established safety algorithms.
Treatment of Common Prostate Cancer
Researchers at UTSW have found that the prostate cancer treatments suppress immune response and may promote relapse.
Cancer Drug Could Treat Blood Vessel Deformities
A drug currently being trialled in cancer patients could also be used to treat an often incurable condition that can cause painful blood vessel overgrowths inside the skin.
Scroll Up
Scroll Down
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,200+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,800+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!