Stira Pharmaceuticals specializes in the development of complex generic products, focusing on various dosage forms such as solid orals, topicals, transdermal systems, and injectables. The company employs advanced technologies for analytical research and development, including in vitro permeability testing (IVPT) and in vitro release testing (IVRT), which adhere to FDA guidelines. Their expertise extends to extractables and leachables (E&L) services, which encompass label migration studies, packaging safety and toxicity analysis, and controlled extraction studies for raw materials. Stira's dedicated team of scientists utilizes in-house technology platforms and extensive prior experience to tackle challenging product development projects, ensuring high-quality outcomes.

In addition to product development, Stira Pharmaceuticals offers comprehensive clinical manufacturing services, including blinding, over-encapsulation, and masking. Their state-of-the-art facilities support the production of various dosage forms for investigational use, such as injectables, solid orals, topicals, and transdermal products. The company emphasizes quality assurance through a dedicated team of Qualified Persons and a full analytical laboratory, ensuring compliance with Good Manufacturing Practices (GMP). Stira's capabilities also include packaging solutions tailored for clinical studies, reinforcing their commitment to meeting customer needs in the pharmaceutical industry.

United States

Stira Pharmaceuticals is a Sterile Injectable CDMO with deep pharmaceutical product development and manufacturing experience in small molecules and peptides. At Stira Pharmaceuticals, a team of highly skilled and experienced scientists are developing challenging products using in-house technology platforms, technical know-how and in-depth prior experience. We offer services:
Analytical R &D
Preformation
In Vitro Permeability Testing (IVPT)
In Vitro Release Testing (IVRT)
Extractables & Leachable Testing (E & L)
Formulation Development
Stability Testing
Microbiology
Regulatory Support

Stira Pharmaceuticals

Company Details