APIs
A&C manufactures and distributes a select number of active pharmaceutical ingredients (APIs) for the pharmaceutical industry. Active pharmaceutical ingredients are the active components of a drug product. Our GMP APIs are currently used for numerous applications including dermal, ophthalmic, nasal and OTC drug formulations.
A&C holds a Drug Establishment Licence for active pharmaceutical ingredients manufacturing, labelling, testing and distribution issued by Health Canada.
The active pharmaceutical ingredients list above also includes 2-Phenoxyethanol, for which A&C holds a CEP (certificate of suitability) to the monograph of European Pharmacopeia (Ph. Eur.). All products listed are readily available with all associated supporting documentation.
If you would like A&C to manufacture or distribute an API on your behalf, please Contact Us
Active pharmaceutical ingredients represent the side of our business that has the most demanding requirements for A&C’s quality and regulatory functions. Our other lines – excipients, buffers and process solutions benefit from our participation in the APIs business since our overall quality management system is raised to meet the highest GMP standards. Active pharmaceutical ingredients require the strictest standard for manufacturing, testing, packaging, labelling, importing and distributing.
In order to meet requirements for our APIs, A&C is routinely audited by Health Canada for all of the aforementioned activities related to APIs. 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 uses fully qualified, validated, and calibrated testing and measuring equipment. It also means that we rigorously comply to data integrity requirements. Necessarily, our manufacturing and cleaning procedures are fully validated and maintained according to our validation master plan. We have validated and qualified container closure systems for our products supported by long-term stability testing. Furthermore, our products are warehoused and distributed in compliance with GDP guidelines.
We are registered with the FDA as a foreign Drug Establishment. While meeting these requirements, A&C does not sit still and our quality management system is constantly improving by ongoing self-auditing, by periodic regulatory audits, certification audits and audits by our major international customers.
At A&C, we view our quality management system in a holistic way. The manufacturing controls, methods, product handling, rigorous testing, continuous improvement, verification and validation activities are all interconnected and interdependent. One direct example of this is our new product development process validation report. The CTD compliant format is used for all of our newly developed products. This allows us, when developing APIs, to easily file a Drug Master File (DMF) or ASMF. This approach was developed when we filed to obtain the certificate of suitability (CEP) for Phenoxyethanol Multi-Compendial API grade. Thus, our licenced business in actives offers the benefit of meeting the highest standards for all of our products – active pharmaceutical ingredients, excipients, buffers and process solutions. Our customers can rest assured, if it’s made by A&C, it is actively GMP.
Contact Our Technical Support Team if you have a query regarding DMF registration of one of our products.
