Client Challenge

A global pharmaceutical manufacturer encountered a critical supply chain disruption when their API supplier unexpectedly terminated the partnership. As a result, a substantial quantity of active pharmaceutical ingredient (API), though properly stored and controlled, was at risk of expiration due to a lack of FDA approval. The situation was further complicated by uncertainties regarding the completeness of the supplier’s Drug Master File (DMF), the availability of essential development and stability data, and the absence of a qualified replacement supplier.

RCA Approach

Regulatory Compliance Associates® Inc. (RCA) was engaged to resolve the issue and safeguard the client’s valuable API inventory. RCA initiated a comprehensive retesting protocol, confirming that the API had remained stable and within specification under controlled storage conditions. To reestablish supply continuity, RCA identified and qualified a new supplier, while deploying analytical chemists and development scientists to address critical manufacturing challenges—including issues with particle size and crystal drying in the new production process.

Concurrently, RCA’s regulatory experts located and thoroughly evaluated the previous supplier’s Drug Master File (DMF), uncovering essential development and stability data. Leveraging this information, RCA assisted the client in compiling and submitting a CBE-30 supplement to the FDA. This strategic submission enabled the client to gain FDA approval for continued use of the existing API, despite the supplier transition.

Result

The FDA found no deficiencies in the submission, allowing the pharmaceutical company to proceed with the use of the original API—realizing cost savings estimated in the eight-figure range. In parallel, RCA updated and streamlined the company’s Common Technical Document (CTD) framework, delivering structured templates to support ongoing lifecycle management of the product. This comprehensive effort not only averted a costly API replacement but also safeguarded a critical revenue stream and reinforced the long-term stability and compliance of the manufacturing process.