Menu
About us
Process solutions, buffers, excipients, and a restricted selection of active pharmaceutical ingredients (APIs) are all produced by A&C, a global GMP company. We have been offering services to the life science industry since 1966, and we have grown our global footprint over time. We currently run offices and GMP production facilities throughout North America and Europe.
We are a customer-focused company that comes up with creative solutions for our clients’ GMP issues. Since we are a privately held company, transparency, quality, and flexibility are key components of our operations. A&C’s multiple quality certifications serve as proof of this:
- ISO 9001:2015*
- GDP and EXCiPACT GMP for excipients
- Authorization to Produce Medicinal Items
- Health Canada and the FDA audited
As they are essential to our business decisions, we remain committed to ensuring that GDP and GMP are adhered to as well as that all international regulatory standards are met.
Choose AnItem &C produces a variety of goods at our three GMP manufacturing facilities. We began manufacturing high purity solutions on demand in 1966. Our chemicals are employed as buffers, lubricants, binders, antioxidants, process solutions, cleaning solutions, preservatives, pH adjusters, and aromatic and flavoring compounds, in addition to injectable, dermal, nasal, and ocular applications. We offer GMP customized services, including GMP custom ingredient creation, GMP custom manufacturing, and GMP custom packaging available in a range of FDA-approved formats, for all of our excipients and raw materials.
*A&C’s manufacturing locations having QMSs certified to ISO 9001:2015 are:
- Site A: 3010 rue de Baene, Montréal, QC H4S 1L2, Canada.
- Site B: 20325 avenue Clark-Graham, Baie-D’Urfé, QC H9X 3T5, Canada
- Site C: Grange Business Park, Skule Hill, Fedamore, County
2019
In 2019, A&C joined two distinct Canadian biotech associations, BIOTECanada and BioAlberta, as well as North Carolina Biotech.
2018
2018 saw the awarding of a Certificate of Suitability (CEP) for 2-Phenoxyethanol API grade by EDQM and an ISO 9001:2015 certification*.
2017
With the opening of A&C Bio Buffer and a brand-new, cutting-edge manufacturing facility in Limerick, Ireland, in 2017, the company’s European expansion continued.
2016
In Baie-D’Urfé, Canada, we constructed our second GMP manufacturing facility in 2016.
2015
We increased our presence in Europe in 2015 by setting up new offices in Ireland. We have been in possession of Health Canada’s Drug Establishment Licence for API manufacturing, labelling, testing, and distribution since 2015.
2014
We were granted the EXCiPACT certification for GDP and GMP in 2014. We were the first manufacturer of excipients in North America to be certified by this globally recognized accrediting body. We finished registering with the FDA to manufacture pharmaceutical ingredients that same year, and we were given approval by the agency.
2012
2012 saw us obtain the ISO 9001:2008 certification, demonstrating our unwavering dedication to quality—one of our company’s key principles.
2011
2011 saw the completion of GDP warehousing at our main manufacturing site in Canada, in addition to all GMP facility renovations. We established A&C United States and a new sales office in North Carolina.
2008
With the help of EDQM (European Directorate for the Quality of Medicines), we conducted the first Ph. Eur 6th Edition training session in Canada in 2008, demonstrating our ongoing dedication to upholding high standards of quality.
2007
A&C upgraded to a GMP environment in 2007 and proceeded with our expansion for both new and existing products.
2006
We held the inaugural USP Educational Forum Conference in Montreal in 2006. Maintaining quality as our first priority, we successfully registered the USDMF for Azelastine HCL with the FDA that same year, completing an FDA audit, a DMF review, and a Manufacturer approval.
1990
The product line was expanded in 1990 with the addition of cleaning and buffer solutions, which caused the plant’s production and warehouse to double.
1975
After USP Reference Standards were distributed, A&C was recognized as the world’s oldest USP distributor in 1975.
1966
In 1966, we constructed our first facility in Montreal, Canada, to handle a rise in sales as well as the development and expansion of new products. For more than 25 years, the company’s annual growth was mostly driven by the production of laboratory chemicals and fine chemicals.
Stay Connected With Us
A&C Canada
A&C Europe
A&C United States
