ABOUT US
A&C is a global GMP manufacturer of excipients, buffers, process solutions and a select number of active pharmaceutical ingredients (APIs). We have been servicing the life science industry since 1966, and expanded our footprint globally through the years. We currently have offices and GMP production facilities in North America and Europe.
We are a service driven organization finding unique solutions to our customers’ GMP challenges. We are a privately owned company where flexibility, transparency and quality are at the core of all of our activities. This is demonstrated through the numerous quality certifications that A&C holds:
- ISO 9001:2015*
- EXCiPACT GMP and GDP for excipients
- Drug Establishment Licence for manufacture of APIs
- FDA and Health Canada audited
We remain committed to ensuring adherence to GMP and GDP and full compliance in meeting the international regulatory requirements which are key for our business decisions.
A&C works with a variety of products at our three GMP manufacturing facilities. We began with custom manufacturing of high purity solutions in 1966. The applications of our products include injectable, dermal, nasal, ophthalmic applications, preservatives, pH adjusters, cleaning solutions, solvents, flavours and aromatic compounds, lubricants, binders, antioxidants, process solutions and buffers. We offer GMP customized services for all our excipients and raw materials, including GMP custom ingredient development, GMP manufacturing and GMP custom packaging available in a wide range of FDA approved formats.
*A&C’s ISO 9001:2015 certified QMS manufacturing facilities are:
– Site A: 3010 rue de Baene, Montreal, 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, Co. Limerick, Ireland
2019
In 2019, A&C became member of North Carolina Biotech and of two separate Canadian biotech associations named BIOTECanada and BioAlberta.
2018
In 2018, we received the ISO 9001:2015 certification* and a Certificate of Suitability (CEP) for 2-Phenoxyethanol API grade awarded by EDQM.
2017
The expansion into Europe continued in 2017 with the opening of A&C Bio Buffer and a new state-of-the-art manufacturing facility in Limerick, Ireland
2016
In 2016, we built our second GMP manufacturing facility in Baie-D’Urfé, Canada.
2015
In 2015 we expanded into Europe and opened new offices in Ireland. Since 2015, we have been holding the Drug Establishment Licence for API manufacturing, labelling, testing and distribution issued by Health Canada.
2014
In 2014 we received the EXCiPACT certification for GMP and GDP. We were the first excipient manufacturer in North America to receive the certification from this world renowned accreditation body. In that same year, we completed our registration with FDA for pharmaceutical ingredient manufacturing and we received FDA approval.
2012
We received the ISO 9001:2008 certification in 2012, showing continuous commitment to quality, one of the core values of our company.
2011
In 2011 we completed all GMP facility renovations, as well as GDP warehousing at our main manufacturing site in Canada. A&C United States was launched and we opened a new sales office in North Carolina.
2008
In 2008, we held the first Ph. Eur 6th Edition training session in Canada with EDQM (European Directorate for the Quality of Medicines) which demonstrated our continuous focus and commitment on keeping high quality standards.
2007
In 2007, A&C continued our expansion and upgraded towards GMP environment for both our new and existing products.
2006
In 2006 we hosted the first USP Educational Forum Conference in Montreal. Keeping quality at the core of our business, in that same year, we successfully registered USDMF for Azelastine HCL with FDA, which included an FDA audit, a DMF review, and a Manufacturer approval.
1990
In 1990, buffer and cleaning solutions were introduced to the product range which led to a plant expansion as production and warehouse doubled.
1975
In 1975, following the distribution of USP Reference Standards, A&C was awarded the oldest USP distributor worldwide.
1966
Our first facility was built in Montreal, Canada in 1966 to accommodate an increase in sales and to allow new product development and growth. For over 25 years the business continued to grow yearly mainly with fine chemicals and laboratory chemical manufacturing.
