In 2015, many new challenges will be faced by pharmaceutical manufacturers and their supply chain partners. It is imperative that your business can efficiently adapt to changes while also improving business units. The drivers of the challenges expected to be seen in 2015 include both FDA Drug Quality and Security (DQSA) and local California legislation changes, technological advances and changes in marketplace competition. The top 5 challenges expected in 2015 relate to the implementation of serialization technology, expiration of patents, the increased availability of generic drugs, information traceability requirements and the adaptation of supply chain strategies throughout the market.

With the changes to governmental regulations affecting pharmaceutical manufacturers, strict serialization requirements have been set. Although regulation went into effect November 2014, businesses have time to implement. These new regulations are purposed to help counteract counterfeit pharmaceuticals from entering the supply chain and reaching consumers.

Expiration of patents poses challenges to many pharmaceutical manufacturers as main revenue generating product lines are now available to competitors, requiring these businesses to search for other revenue streams and cost saving opportunities.

Once these patents have expired, generics will flood the market, reducing profit margins for all manufacturers, not simply the original manufacturer. It will be a large focus of many manufacturers to decrease the production costs of these items.

Another aspect of the new regulation changes requires pharmaceutical manufacturers to provide detailed audit trail data at any point in the manufacturing process. This is also required for any logistics provider handling the finished product. If a solution has not already been implemented that can track ingredient level details, it will be an undertaking to find a solutions provider that can help your business meet these federal regulations.

To counteract many of these issues, pharmaceutical manufacturers have begun to adapt their supply chain strategies to increase profit margins. Many have done this by cutting links in their supply chain and dealing with consumers and pharmacies directly. This poses problems for manufacturers as many are not equipped with the proper technology to handle direct to consumer delivery.

By selecting a robust and flexible inventory management system, many pharmaceutical manufacturers can mitigate or even eliminate these top 5 challenges. To learn more about a warehouse management solution (WMS) designed to handle your pharmaceutical supply chain and federal regulatory compliance contact Datex experts today at 800.933.2839 ext 243 or

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