Background

A global manufacturer of pharmaceuticals was facing the potential expiration of a substantial quantity of API when their API manufacturer suddenly exited the relationship. The API was controlled and maintained in storage but had no FDA approval or updated FDA Regulatory Submission.

Additionally, there was a question about the supplier’s Drug Master File (DMF), the development data, and the process for setting up a new supplier.

Solution

Regulatory Compliance Associates^® Inc. was asked to remedy the situation. RCA retested the API, ensuring the controlled storage had indeed maintained the API with no degradation. Further, RCA qualified a new supplier, solving manufacturing issues by bringing analytical chemists and development scientists. The scientists addressed particle size and crystal drying issues that emerged within the new supplier’s manufacturing process.

RCA also brought in a regulatory team that assessed the previous API supplier’s DMF. The team found significant API development work, and stability data and enabled the pharmaceutical client to submit a CBE 30 supplement. This enabled the FDA to update the information needed to approve the use of the API.

Result

Not a single deficiency was found in the Regulatory Submission. The pharmaceutical company was able to use the original API, savings well into the 8-figure range. Additionally, RCA organized and updated the company’s Common Technical Documents (CTD), giving them templates for the life cycle management of the drug going forward. This enabled the pharmaceutical company to avoid a large API expense, maintain a revenue stream of the product, and ensure a stable manufacturing process going forward.

 

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