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When faced with drug shortages or supply chain issues affecting a branded drug product, generic drug manufacturers need to move quickly to help ensure that needed therapies reach the market safely and efficiently. Access to high-quality packaging and delivery components can make a huge difference in ensuring patients receive life-saving medications on schedule.
At West, we work by the side of our generic drug partners to ensure that they have access to components that not only meet the increasing demand for better quality packaging and delivery for generic drug products, but also provide the efficiencies they need to make the move to market fast.
Speed to market is also important for generic customers who may hold a number of Abbreviated New Drug Applications (ANDAs ) and need to move quickly to produce different products in their portfolio, which can be driven by market conditions such as drug shortages where there is a need to respond immediately.
Our AccelTRA® component program provides a robust, efficient platform of components that are compatible with a broad variety of generics molecules and chemicals. This program offers customers the possibility of building a platform of delivery options and packaging for a variety of molecules with a single supply platform.
In addition, West has built a global supply chain network to provide made-to-stock AccelTRA components with extremely fast sampling and delivery lead times. Samples are available with a one-week lead time, and commercial quantities within six weeks.
At West, we’re by your side with excellent technical service that helps customers work through issues and make the move to market fast. We bring the service solutions – including laboratory services, contract manufacturing, and regulatory support for a growing number of proprietary delivery devices – so that customers that need to move fast have the services available to help.Click the links for more information about our AccelTRA program, or our Integrated Solutions (link) program.
AccelTRA® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
The pharmaceutical industry is shifting toward pre-filled syringes (PFS) as the optimal delivery system for many drug products. The utility of a syringe system is dependent upon its ability to maintain good container closure integrity (CCI) through drug product shelf life.<br />
The impact of a cancer diagnosis can be stressful. Questions such as “how will I tell my family?”, “how will I afford to pay my bills?”, “will I ever work again?” and even “will I survive?” <span>are at the forefront of the patient’s mind as they process their diagnosis and begin treatment</span>. So, how can the patient experience with treatment be supported? By offering the best quality of care.
West’s Senior Vice President and Chief Commercial Officer Karen Flynn was one of four Chester County, Pennsylvania women to be acknowledged by the March of Dimes as a Women of Achievement Honoree.
In 1987, the International Organization for Standardization (ISO) issued the first version of ISO 9001, a standard intended to define the basic requirements, structure, responsibilities, and procedures required to implement an effective quality management system for manufacturing organizations in general. In 1996, the International Organization for Standardization issued the first version of ISO 13485, “Quality Systems—Medical Devices—Particular Requirements for the Application of ISO 9001,” to specify, in conjunction with the application of ISO 9001, the Quality Management System (QMS) requirements for medical device manufacturers. Today, ISO 13485 is used internationally by many regulatory authorities as the foundation for defining regulatory QMS requirements for medical device manufacturers and is utilized in regulatory harmonization programs such as the Medical Device Single Audit Program (MDSAP).
As this year’s annual West without Borders campaign begins to wind down, West colleagues at the Exton, Pa., headquarters spent June 22 at the Lionville YMCA raising funds for <a href="http://cure4cam.org/"><span style="color: #0000ff; text-decoration: underline;">Cure4Cam</span></a> and <a href="http://www.miracleinmotion.org/Home_Page.php"><span style="color: #0000ff; text-decoration: underline;">Miracle in Motion</span></a>.