We are a pharmaceutical contract development and manufacturing organization (CDMO). Our range of services includes development, manufacturing, packaging, and serialization. The range of products we are capable of producing includes over-the-counter (OTC) and prescription drug products, dietary supplements, and professional skincare.


Our expertise is in the development and manufacture of OTC and prescription drug products, dietary supplements, and professional skincare. Our system is built to ensure that these products meet current regulatory requirements. Quality CDMO is located in Fort Worth, Texas in a 44,000 sq. ft. facility which is cGMP compliant and is registered with the FDA and Texas Department of Health to produce liquid and semi-solid products including OTC and prescription drug products, dietary supplements, and professional skincare.

 

Why Choose Us

  1. Expertise in OTC Liquid and Cream Formulations: Our team of seasoned professionals possesses extensive experience and expertise in formulating a wide range of OTC liquid and cream pharmaceutical products. From cough syrups to skin creams, we have the know-how to develop formulations that meet the unique needs of the OTC market.

  2. State-of-the-Art Facilities: Equipped with cutting-edge technology and compliant with current Good Manufacturing Practices (cGMP), our manufacturing facilities ensure the highest standards of quality and regulatory compliance. Our facility is also DSCSA Serialization capable, enabling us to meet the traceability requirements mandated by the Drug Supply Chain Security Act (DSCSA).

  3. Customized Solutions: We understand that every OTC product is unique. That’s why we offer customized solutions tailored to your specific needs and requirements. Whether you require formulation development, analytical testing, process optimization, or full-scale manufacturing, we have the flexibility and agility to accommodate your demands.

  4. Quality Assurance: Quality is our top priority. Our rigorous quality assurance processes and procedures ensure that every OTC product that leaves our facility meets the highest standards of quality, safety, and efficacy. From raw material sourcing to final product release, we adhere to stringent quality control measures at every step of the manufacturing process.

  5. Commitment to Compliance: As an FDA audited facility, we uphold the highest levels of regulatory compliance. Our facilities undergo regular inspections and audits to ensure compliance with FDA regulations and global regulatory standards. This commitment to compliance ensures that your OTC products meet regulatory requirements and market expectations.

  6. Collaborative Partnership: We believe in fostering strong, collaborative partnerships with our clients. Our dedicated team works closely with you throughout every stage of the project, from initial concept to commercialization, to ensure that your vision is realized and your goals are achieved.

 

Quality CDMO is cGMP compliant and audited by the FDA and Texas Department of Health.