Sovereign Pharmaceuticals, LLC, is a privately owned and operated, full-service, contract developer and manufacturer established in 1990. Sovereign is centrally located in Fort Worth, Texas, and occupies a 54,000 ft cGMP production facility and a 10,000 ft cGMP R D facility. Sovereign specializes in developing and manufacturing oral tablets, oral capsules, oral and topical solutions, and oral suspensions. Sovereign’s committed team of employees excels in cGMP compliance and is focused on customer service by delivering high quality products at a competitive price in a timely manner. Sovereign emphasizes the development and filing of ANDAs, INDs, and 505(b)2 NDAs. They offer expert services in all aspects of the development process for filed products. They perform all stability studies under ICH guidelines, assemble the CMC section, and file the applications in eCTD format with the FDA on their customer’s behalf. Their talented R D organization has the experience to match the desired bioavailability of immediate-release and sustained-release products to expedite your time to file and reach approval. Their regulatory staff has the expertise to monitor biostudies if required. Their experienced Business Development and Regulatory Affairs team can assist you in designing a unique product with minimal clinical requirements. Sovereign remains focused on the customer. They continually upgrade their equipment and facilities to meet the demands of their customers. They hire experienced professionals to take them into the future as a first-class pharmaceutical company. When you sign a contract with Sovereign, you can have the peace of mind that they will handle the entire process and deliver to you a quality product within budget and on time.