Dalton Pharma Services Announces Successful Completion of Health Canada Inspection

Dalton announces successful completion of Health Canada Inspection and Compliance with European Directive for Manufacture and Testing of Drug Products Imported to the European Union.

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Dalton Pharma Services

Feb 01, 2010, 12:46 ET

TORONTO, Feb. 1 /PRNewswire/ -- Dalton Pharma Services, a privately owned Canadian pharmaceutical services provider to leading pharmaceutical companies, today announced successful completion of its recent Health Canada audit. The Company has received a 'Compliant' rating following the regulatory agency's inspection of Dalton's GMP manufacturing facility.

The Establishment License issued by Health Canada will enable Dalton Pharma Services to continue to manufacture, test and ship sterile commercial products for its existing clients. In addition, Dalton's solid dose manufacturing suites were also inspected and found to be compliant for formulation, granulation and encapsulation of drug products.

In separate audits by Qualified Persons, Dalton Pharma Services was also found to be compliant with GMP API manufacturing, sterile filling and testing standards for pharmaceutical products in the European Union.

"These successful inspections will allow us to continue to execute on our vision to accelerate drug development for our clients' pharmaceutical products globally. Dalton's ability to carry out commercial manufacture of sterile, solid dose pharmaceuticals and API provides integrated drug development and manufacturing solutions. Dalton's reputation for its ability to complete complex drug manufacturing projects in GMP compliant facilities enhances our clients' success in bringing the medicines of the future to the market," said Peter Pekos, President and CEO.

Many of Dalton's international clients have capitalized on the tremendous advantage of dealing with one CMO from start to finish; from clinical trial manufacturing through to commercial production. Dalton is strategically poised for growth within the EU as the Company adds new commercial pharmaceutical manufacturing relationships.

About Dalton Pharma Services

Dalton Chemical Laboratories Inc. o/a Dalton Pharma Services is a Health Canada approved contract pharmaceutical manufacturer that supplies chemistry, analytical and formulation development services to the biotechnology and pharmaceutical industries in the areas of chemistry, medicinal chemistry and fine chemical manufacture. Dalton provides cGMP manufacturing of solid dosage forms 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 produces active pharmaceutical ingredients at the gram or kilogram scale. Dalton conducts 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, Dalton's analytical chemistry laboratory offers method development, validation and ICH stability programs to its clients.

About Dalton Medicinal Chemistry

Dalton Medicinal Chemistry Incorporated (DMC) was established to offer select partners medicinal chemistry capabilities in design and synthesis of new chemical entities.

DMC focuses on quality, creativity and speed in the delivery of innovative, high quality medicinal chemistry capabilities for the identification of new chemical entities which advance our clients' drug discovery programs. Our contributions to clinical development candidate selection include SAR elucidation, design and synthesis of focused compound arrays, hit to lead, lead optimization and generation of intellectual property. DMC has full access to Dalton Pharma Services (DPS) and its world class synthetic laboratories equipped with the latest technology in modern synthetic chemistry, structural determination and purity assessment.