Chattem holds four DEA registrations that cover bulk manufacturing, importing, exporting, and analytical activities for controlled substances schedules 1 through 5. Chattem has an in-house DEA regulatory expert proficient in 21 CFR regulations, drug code additions to DEA registrations, import and export requirements, and quota applications. Regulatory compliance spans site-wide, as Chattem’s DEA audit history displays successful audits with zero observations.

Chattem has a strong history of meeting and exceeding regulatory requirements. Chattem has regulatory experts on site to make sure there are no unforeseen issues that arise to compromise your project as well as access to regulatory experts through Sun Pharma’s global network of personnel. With experience performing various submissions globally and the capability to support custom projects, Chattem’s regulatory department is the final step to helping get your API to market.