Services

Clinical Trials

American Antibiotics Clinical Trials

Using good scientific practices, our goal is to move the compound from the preclinical into the clinical development stage as quickly as possible.

During the development process, American Antibiotics reviews the formulation data and along with the client agrees upon the manufacturing schedule for clinical trial supplies based on the customer’s needs and API availability. This enables our customers to make timely decisions from proof of prIncipal studies regarding future clinical development plans.

Clinical Trial Materials (CTM) Manufacturing and Packaging Services

American Antibiotics can manufacture supplies to support:

-Phase I studies
-Phase II studies
-Phase III studies
-Phase IV studies

Production scalability allows for the manufacture of Clinical Trial Materials (CTM) from less than 1 kilogram to 1,00 kilogram batch sizes.

American Antibiotics provides packaging in bottles and/or blister packs that can be labeled for open and/or blinded clinical studies.

Capabilities

American Antibiotics beta-lactam antibiotic manufacturing capabilities Include the following:

  • Tablets (uncoated, film-coated, enteric-coated and sugar-coated)
  • Capsules
  • Modified release tablets and capsules (extended release, delayed release and long acting)
  • Powders
  • Granules
  • Oral Suspensions
  • Injectables