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Pharmaceutical Product
& Contract Manufacturing

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.

Pharmaceutical Manufacturing Services

  • 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—COMING SOON
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 Sovereign Product Development Successes

NDAs
  • 7 Approved
  • 2 Under Development
ANDAs
  • 16 Approved
  • 7 Pending FDA Approval
  • 2 Under Development
ANADAs
  • 1 Approved
  • 1 Under Development

We're in Dallas-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

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