1200 USP Chemicals

Spectrum Chemical Mfg. Corp. is unique in the chemical industry, providing one of the largest selections of fine chemicals while also remaining a family-owned business for nearly fifty years. We are an FDA registered manufacturer and we are registered with the DEA as a manufacturer of Controlled Substances (Schedules I - V). Spectrum has the largest selection of USP, NF, FCC, BP, EP & JP chemicals for manufacture of food, drug and personal care products available from a single source. Our multi-decade progress and continued business success stems from our dedication to providing more for our customers each year.

Spectrum has the largest selection of monograph chemicals available for manufacture of food, drug and personal care products, with more than 1,200 USP, NF, FCC, BP, EP & JP Chemicals. Products are available in laboratory and production quantities, with more than 700 USP chemicals in bulk sizes.

View all our Pharmaceutical Chemical Ingredients:

• USP- NF - FCC - BP - EP - JP Grade Chemicals

• USP & NF Grade Chemicals

• Controlled Substances (Schedules I - V)

• Excipient Chemicals

• Pharmaceutical Research Chemicals

• Active Pharmaceutical Ingredients

• Analytical Reagents For USP Testing

All monograph products are manufactured, packaged and stored under current Good Manufacturing Practices (cGMP) per 21CFR parts 210 and 211 in FDA registered and inspected facilities in California and New Jersey. Spectrum’s change control capabilities ensure that your specifications and requirements remain locked in, providing a seamless transition from process development through pilot, scale-up and production.

The Spectrum Difference? Documentation and Change Control.

Spectrum's certification to ISO 9001:2015 standards along with strict adherence to current Good Manufacturing Practices (cGMP) form the foundation of our Integrated QualitySM (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 ensure that our products are compliant with the US FDA, DEA, ICH WHO and other worldwide regulatory entities. We provide the documentation and change control you need.

Here are some of the ways Spectrum is committed to providing you the highest quality raw materials:

• 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 is registered with the DEA as a manufacturer of Controlled Substances (Schedules I - V).

• Spectrum performs manufacturer site audits to ensure regulatory compliance and batch-to-batch consistency.