Unique solutions to our customer GMP’s challenges
Successful biopharmaceutical manufacturing strategies depend on the quality of raw materials. While much effort is spent to develop active ingredient specifications, excipients and other non-active raw materials could be taken for granted. Thus, raw material qualification is extremely important in ensuring process control and final product quality and we understand that each customer has unique product needs requiring tailored solutions.
Through our integrated centers of excellence facility network in North America, Europe and India, Aceto is a global GMP manufacturer of excipients, buffers, process solutions, and a select number of active pharmaceutical ingredients suitable biopharmaceutical applications. Should you require a specific excipient or other raw material to be manufactured within a fully compliant GMP process, Aceto offers this service with full supporting documentation. Our R&D team has over fifty years of experience in problem-solving for customer ingredient development.
Aceto is renowned for our high quality standards and provides full transparency in the supply chain, which is vital for compliance with GMP and GDP. We provide regulatory support for all products by having a detailed supply chain statement. Customers are notified of significant changes through a strict change control program.Our Biopharma manufacturing facilities hold all the major certifications and applicable licences from the main accreditation bodies and agencies:
- ISO 9001:2015 certified*
- GMP and GDP EXCiPACT certified for excipients
- Health Canada Drug Establishment Licence for Active Pharmaceutical Ingredients manufacturing
- FDA and Health Canada audited
- Process Solutions
- Raw Material
- GMP Custom Ingredient Development
- GMP Manufacturing
- GMP Custom Packaging
- Analytical Services