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.

 

 

QUALITY COMPLIANCE FOR APIs

 

Active pharmaceutical ingredients represent the side of our business that has the most demanding requirements for Aceto's quality and regulatory functions. Our quality management system is designed to meet the highest GMP standards as APIs require the strictest standards for manufacturing, testing, packaging, labelling, importing and distributing.

 

In order to ensure we continuously meet the regulatory requirements for our APIs, our facilities are routinely audited by regulators. We also meet the requirements for pharmaceutical manufacturing, set out by ICH Q7 and associated guidance. Meeting the ICH guidance means our testing is validated and employs fully qualified, validated, and calibrated testing and measuring equipment. It also means that we rigorously comply to data integrity requirements.

 

Our manufacturing and cleaning procedures are fully validated and maintained according to our validation master plan. Furthermore, our products are warehoused and distributed in compliance with GDP guidelines.

 

If you would like Aceto to manufacture or distribute an API on your behalf, please Contact us