Dalton Pharma Services Rated Compliant with New Health Canada API Regulations

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Dalton Pharma Services today announced that a recent Health Canada inspection of its API manufacturing operations resulted in a “Compliant” rating against the newest Health Canada API manufacturing guidance.

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Dalton is very pleased that Health Canada has implemented the new rules to support a safer drug supply chain, and has found Dalton to be compliant with these important regulations.

Dalton Pharma Services today announced that a Health Canada inspection of its API manufacturing operations resulted in a “Compliant” rating against a recently created Health Canada API manufacturing guidance.

In November of 2013, Health Canada implemented Guidance GUI-0104, Good Manufacturing Practices (GMP) Guidelines for Active Pharmaceutical Ingredients (API). The recent inspection was the first time Dalton’s API operations had been inspected under the new guidance.

GMP API production has been a core focus for Dalton throughout most of its 29-year history.

A wide range of GMP small molecule APIs is manufactured for its global customer base on a contract basis. The Company conducts cGMP manufacturing of API's from bench top to multi-kilo scales in its API suites rated at Class 10,000 (Class C). Its upgraded cGMP manufacturing areas can support reactor sizes up to 300L.

“Ensuring quality and consistency in all aspects of drug product manufacturing is a priority at Dalton, and naturally extends to our API manufacturing processes”, said Karina Lahnakoski, Director of Quality, Dalton Pharma Services. “We are very pleased that Health Canada has implemented new rules to support a safer drug supply chain, and has found Dalton to be compliant with these important regulations.”

About Dalton:
Dalton Chemical Laboratories Inc. o/a Dalton Pharma Services is a leading cGMP contract service provider of integrated chemistry, drug development and dosage form manufacturing services to the pharmaceutical and biotechnology industries. Dalton provides expertise in medicinal chemistry, process development and reaction optimization, as well as formulation development, analytical testing and development, and cGMP manufacturing including cGMP API production and cGMP Sterile Filling Services including Sterile Powder Filling. Dalton brings nearly 30 years of experience to every customer project, at virtually any stage of development or commercialization.

http://www.dalton.com

Dalton Contact
Peter Pekos
Dalton Pharma Services
416-661-2102
ppekos(at)dalton(dot)com

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Peter Pekos