cGMP API Services

cGMP API Customers

Dalton provides GMP API manufacturing to meet regulatory requirements including U.S. FDA, Health Canada and EMA standards.

The following quotes are examples of the feedback we have received from our API customers.

“I was most impressed by your operation from both a GMP and regulatory perspective.”
- GMP Compliance Manager, Corporate Quality

“I was particularly impressed with the knowledge of the staff that were present during the visit and the continuous improvement approach....”
- Director of Quality and QP

“There is a very knowledgeable team at Dalton. The level of GMP compliance of the facility was considered satisfactory for the continued manufacture of API and for Drug Products to be imported to EU.”
- CEO, QP

“....Dalton Pharma Services had a well functioning and effective quality system
....All involved personnel gave a very competent impression.”
- ISO/GMP Lead Auditor