Research & Development

American Antibiotics Research & Development

American Antibiotics product development services are designed to speed commercialization.

American AntibioticsĀ  delivers comprehensive services from conception, through development, to scale-up manufacturing and commercialization. We are dedicated to cost-effectively accelerating our customers' time to market. Our extensive team of experienced scientists have been leaders in developing generic beta-lactam antibiotic pharmaceuticals for customers around the world.

Formulation Development

American Antibiotics has a broad knowledge and technical experience in dosage form development and GMP manufacturing. American Antibiotics is able to provide clients with a wide range of options to develop small molecules into quality pharmaceutical products. The key to our success is being able to provide a flexible approach for the client whether it is a step by step approach to development work or simply the transfer of a product into development at late stage.

American Antibiotics highly trained scientific team has extensive experience working with a variety of drug substances, with a range of physiochemical characteristics.

Analytical Development

American Antibiotics has developed analytical testing methods to meet all project specifications while ensuring rapid development. U.S. Food and Drug Administration (FDA)- and International Conference of Harmonization (ICH)-compliant processes Include:

  • Cleaning validation
  • Method validation
  • Dissolution profiling
  • Forced degradation studies
  • Stability studies
Efficient Formulation

American Antibiotics has adopted efficient formulation development processes Including:

  • Characterization of physical and chemical properties
  • Compatibility studies
  • Formulation optimization
  • Manufacturing process identification
  • Scale-up for commercial manufacturing
  • Process validation