GMP Manufactured Chemical Blends

Puritan Products offer solutions for custom chemical blends using compendial raw materials.

GMP Manufactured Chemical Blends using Compendial Raw Materials

• USP – United States Pharmacopeia
• NF – National Formulary
• FCC – Food Chemical Codex
• EP – European Pharmacopeia
• BP – British Pharmacopeia
• JP – Japanese Pharmacopeia

cGMP Manufacturing Capability for Pharmaceutical and Biotechnology

In late 2009, Puritan Products completed a growth initiative that raised the level of our quality management system to include compliance with 21 CFR Part 211. This accomplishment places us in a select group of companies that have achieved this goal. As a cGMP compliant company, Puritan Products, by definition, has the quality systems and documentation that make us a viable supplier to those markets that are monitored and regulated by the federal government. We also chose to distinguish ourselves further by validating our ultrapure water system, which now produces water to the USP standard. Current pharmaceutical and biotechnology customers are working with Puritan Products to manufacture bulk pharmaceutical chemicals, custom blended solutions and dilutions, process intermediates, and cleaning chemistries among others. We have been successful in providing a value proposition that makes outsourcing these products an attractive alternative to “in-house” production. Our laboratory staff has the expertise to validate analytical methods to meet the stringent demands of these customers while offering the flexibility to customize the certificate of analysis. We enjoy many long-standing supplier relationships that address the continuing needs for transparency in supply chain management. Call us today to discuss how these high quality systems and processes can be made to work for you!