Quality Commitment

Spectrum's certification to ISO 9001:2015 and ISO 17025:2005 standards along with strict adherence to current Good Manufacturing Practices (cGMP) form the foundation of our Integrated Quality^SM (IQ) program. All raw materials and finished goods entering our facilities are subject to stringent in-house testing in our analytical laboratories to ensure all chemicals and ingredients meet our own high quality standards.

Spectrum’s extensive knowledge and experience in the changing global regulatory environment ensures that our products are compliant with the US FDA, DEA, ICH WHO and other worldwide regulatory entities.

Quality - #1 Priority

• All of Spectrum’s global manufacturing and distribution sites are FDA registered and operate under current Good Manufacturing Practices (cGMP).

• All Spectrum facilities are certified to the current ISO 9001:2015 quality standard.

• Spectrum’s Shanghai, China analytical laboratory is certified to the ISO 17025:2005 quality standard as an independent third-party testing laboratory.

• Spectrum is registered with the DEA as a manufacturer of Controlled Substances (Schedules II - IV).

• Spectrum regularly performs manufacturer site audits to ensure batch-to-batch consistency.