About Element Wilmington

Element Wilmington is an FDA-registered and DEA-licensed (schedules 2-5) laboratory specializing in clinical-scale, small-batch sterile fill-finish. With deep expertise in both large and small molecule therapies, Element Wilmington offers comprehensive support for a variety of finished dosage forms, including otic and ophthalmic aseptic fills, topicals, semi-solids, and non-aseptic liquid fills, potent compounds, controlled substances, and compounding pharmacy medications and drugs. Element Wilmington provides best-in-class stability programs and storage solutions, with 1,600 sq. ft. of walk-in stability chambers for 25C/60%RH, 30C/65%RH, and 40C/75%RH ICH stability studies.

Customers have an opportunity to view work being done in ISO Class 5/Class 7 aseptic core in close proximity, or from a remote location. Element Wilmington has a sterling reputation with local FDA and DEA district offices, as well as CDER, CBER, CDRH, CVM, OGD, FDA, and EMA.

Approvals, accreditations and documents

  • DEA Wilmington Registration 2022
    PDF - 2.07 MB View
  • FDA Registration 2022 Wilmington
    PDF - 40.62 KB View

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