Getting your drug product to market
Byron Chemical Company works with its partners to comply with the necessary submissions that are mandatory during the entire drug approval process. Our philosophy towards this very general term “regulatory” is quite fundamental. We recognize, accept, and appreciate that drug regulations are about ensuring the safety of drug products – and we are proud to contribute towards maintaining the high standards of the industry.
Our diligence to meet customer requirements while maintaining compliance with local authorities has rewarded us with the confidence to service the pharmaceutical drug markets into the future.
Byron Chemical Company maintains an excellent standing with the FDA (Food & Drug Administration), DEA (Drug Enforcement Agency), and other local authorities which regulate the Drug Import & Distribution market.
The following are typical regulatory and drug import areas which we cover to ensure compliance:
DMF & ANDAs
Work closely with our suppliers to maintain DMFs and ANDAs including submissions, annual updates, deficiency responses and other actions required to keep these documents current.
Regulatory Agents & Representatives
Byron Chemical represents our partners as their official US regulatory agents bridging the gap between the US FDA and our international manufacturing partners.
Byron Chemical Company is a drug wholesaler licensed to import, store and distribute various products, including controlled drugs which are registered with the FDA and DEA.
The safety and security of drug distribution is the highest priority for Byron Chemical. In addition to our licenses and registrations, our team maintains membership with C-TPAT (Customs-Trade Partnership Against Terrorism).