Active Pharmaceutical Ingredients
Active Pharmaceutical Ingredients
Aceto manufactures and supplies a wide range of active pharmaceutical ingredients (APIs) to many generic drug companies in the pharmaceutical industry. Active pharmaceutical ingredients are the active components of a drug product. Aceto is a valued partner in our clients' effort to develop and market generic drugs. Our GMP APIs are currently employed in numerous applications, including dermal, ophthalmic, nasal and OTC drug formulations.
One of our acquisitions holds a DEL (Drug Establishment Licence) for active pharmaceutical ingredients manufacturing, labelling, testing and distribution issued by Health Canada. We also hold a CEP (certificate of suitability) to the monograph of European Pharmacopeia (EP) for 2-Phenoxyethanol Multi-compendial API grade. Our APIs are available with all associated supporting documentation.
API DEVELOPMENT
Aceto's process of introducing a new API from pipeline to market spans a number of years and begins with:
- Aceto partnering with a generic pharmaceutical manufacturer by selecting an API, several years before the expiration of a composition of matter patent, for future market sales;
- Manufacturing the API or identifying the appropriate supplier;
- Concurrently utilizing our global technical network to ensure they meet standards of quality to comply with regulations.
Aceto has a pipeline of APIs at various stages of development both in the United States and Europe.
Additionally, we can focus on developing API opportunities to provide alternative second-source options for existing generic drugs. By leveraging our worldwide sourcing, regulatory and quality assurance capabilities, we provide to generic drug manufacturers an alternative, rugged supply chain for existing API products.
