Sincerus specializes in sterile and non-sterile preparations of outsourced pharmaceuticals. Our products are made in accordance with CGMP standards for outsourcing facilities. Our Quality Assurance and Quality Control programs monitor and support ALL preparations through continuous quality improvement initiatives.
Today’s healthcare environment demands a supply chain that can demonstrate and validate its quality. It is essential for institutions, physicians, and patients to know the source and process by which pharmaceutical products are made.
Drug shortages are sure to affect every aspect of healthcare delivery. According to the FDA, a major reason for these shortages has been quality/manufacturing issues. There have been other reasons such as production delays at the manufacturer and delays companies have experienced receiving raw materials and components from suppliers. Discontinuations are yet another factor contributing to shortages. FDA can't require a firm to keep making a drug it wants to discontinue. Sometimes these older drugs are discontinued by companies in favor of newer, more profitable drugs.
With fewer firms making older sterile injectable drugs, there are a limited number of production lines that can make these drugs. The raw material suppliers the firms use are also limited in the amount they can make due to capacity issues at their facilities. This small number of manufacturers and limited production capacity for older sterile injectables, combined with the long lead times and complexity of the manufacturing process for injectable drugs, results in these drugs being vulnerable to shortage. When one company has a problem or discontinues, it is difficult for the remaining firms to increase production quickly and a shortage occurs.
Outsourcing is a cost effective risk mitigating solution. Our thoughtfully designed facility, trained staff, QC and QA all offer a level of quality and safety beyond that of many manufacturers and pharmacies.