Dalton Pharma Services Announces Successful Completion Of Health Canada Inspection

TORONTO, Jan. 26 /PRNewswire/ - Dalton Pharma Services, a privately owned Canadian pharmaceutical services provider to leading pharmaceutical companies, today announced the Company has received a 'Compliant' rating from Health Canada following the completion of the regulatory agency's inspection of Dalton's facility. Formal licensing of the facility will allow Dalton Pharma Services to manufacture sterile products, test and ship commercial products for existing clients in Canada and the EU and to attract and fulfill other commercial pharmaceutical manufacturing relationships.

"Health Canada's recognition of the GMP compliance of our organization is a key milestone in the history of our state of the art manufacturing facility and is the accomplishment of a key strategic priority for our company," said Peter Pekos, President and CEO. "The successful completion of the audit is a confirmation of our commitment to meeting the current best practices in cGMP's that govern sterile manufacturing and testing of drug products. The culture of quality that our employees embody came through in the results of the inspection and the comments of the inspector," continued Peter Pekos.

For the past decade Dalton Pharma Services has been manufacturing as well as testing sterile products and API's under clinical development for customers. Now Dalton's clients can start with Dalton Pharma Services in clinical trial manufacturing and stay with Dalton through commercial manufacturing. This achievement will allow Dalton to continue to execute its vision to accelerate drug development and manufacturing of its clients pharmaceutical products. Dalton's ability to carry out the commercial manufacture of sterile pharmaceuticals and Active Pharmaceutical Ingredients increases the choices of the industry in North America and Europe.

"We are grateful to the hundreds of our clients' auditors that have assessed our cGMP compliance over the years. They have contributed to the excellent audit and helped shape our culture of Quality. The compliant rating is a confirmation of the confidence that many of our clients have put into Dalton's quality systems," said Natalie Lazarowych, Director of Quality.

About Dalton Pharma Services

Dalton Chemical Laboratories Inc. o/a Dalton Pharma Services is a contract pharmaceutical manufacturer that supplies chemistry and analytical services to the biotechnology and pharmaceutical industries in the areas of medicinal chemistry, fine chemical manufacture, custom peptides and antisense oligo production. Dalton provides cGMP manufacturing and sterile filling services to its customers at any stage of the regulatory process (Phase I, II, III or commercial). In its state of the art cGMP facilities, Dalton can produce active pharmaceutical ingredients (API), at the gram or kilogram scale. Dalton can carry out sterile fills to produce batches of finished drug product in vials or syringes, either aseptically filled or terminally sterilized, under fully validated conditions. In addition to drug testing, Dalton's analytical chemistry laboratory offers method development, validation, ICH stability programs and HPLC-MS services to its clients.

CONTACT: Peter Pekos, Dalton Pharma Services, Tel: (416) 661-2102, Fax:(416) 661-2108, ppekos@dalton.com