alert
COVID-19: Learn how we're keeping our people and our partners safe during the global pandemic. Learn More

Product Development

At Sovereign, formulation development is at the heart of what we do. From oral to topical, liquids to solids, we've got all your A's, N's, and D's covered.

Services Offered

  • DEA License Schedule I–V
  • Development of NDAs, ANDAs, ANADAs, 505(b)2 NDAs, and 510(k)s
  • Extensive experience of over 100 APIs
  • Powders for oral solutions or suspensions
  • High-potency suite under construction
Oral tablet formulations
  • OTC, Rx, Narcotics
  • Immediate, sustained and modified release; Sublingual; Quick-dissolving; Chewable; Bilayer; Coated
  • Wet granulation and direct compression
Oral powder-filled capsule formulations
  • OTC, Rx, Narcotics
Oral and topical solutions; oral suspension formulations
  • OTC, Rx, Narcotics
  • With or without sugar, alcohol, and dyes

Recent Successes

NDAs
  • 5 Approved
  • 2 Pending FDA Approval
  • 2 Under Development
ANDAs
  • 13 Approved
  • 7 Pending FDA Approval
  • 6 Under Development
NADAs
  • 1 Under Development
ANADAs
  • 1 Approved
  • 1 Under Development

We're in Fort Worth, and we're waiting to meet you…

We've got facilities we're incredibly proud of, and a team that will put your company first. Stop by anytime.

54k sq ft
cGMP Production Facility
14.5k sq ft
cGMP R&D/QC Facility
100k sq ft
Warehouse & Expansion
5.4k sq ft
Storage / Stability Space

Trusted by the best in the biz

Perspiciatis unde omnis iste natus error sit voluptatem accusantium doloremque laudantium, totam rem aperiam, eaque ipsa.