Unither Pharmaceuticals

Overview

Unither Pharmaceuticals is a contract development and manufacturing organization (CDMO) with over 30 years of experience serving pharmaceutical clients globally. The company operates production sites in France, the United States, Brazil, and China, offering comprehensive services from pre-clinical development through commercial manufacturing.

Core Capabilities

Manufacturing Technologies:

• Blow-Fill-Seal (BFS) single-dose sterile liquids — world leader with annual capacity exceeding 5 billion doses
• Multi-dose preservative-free formulations
• Liquid stick packs, vials, sprays, tablets, tubes, suppositories, and pessaries
• Sterile and non-sterile liquid forms

Development Services:

• Formulation development
• Analytical method development
• Clinical batch and placebo manufacturing
• Stability studies (ICH-compliant)
• Ophthalmic product development and manufacturing
• Co-development programs with close client collaboration
• Regulatory support and comprehensive product documentation for licensing

Manufacturing Services:

• Technology transfer and scale-up from clinical to commercial volumes
• Small-batch manufacturing for rare diseases
• Veterinary pharmaceutical manufacturing
• Commercial-scale production

Therapeutic Areas

Unither serves multiple therapeutic areas including ophthalmology, ENT, injectables, respiratory, and rare diseases. The company has demonstrated expertise in vaccine and biologics compatibility studies and has partnered on ophthalmic drug candidate development.

Regulatory & Quality

Production sites are regularly inspected by supervisory authorities and national health agencies, attesting to facility compliance and process implementation standards.