cGMP Manufacturing

cGMP Manufacturing means more than just the FDA regulations—it is the culture at Puritan Products. We have proven strong quality management systems that ensure quality from the start. From raw material selection to robust operating procedures to investigation of quality deviations to reliable analytical laboratories, we all contribute to providing chemical raw materials that meet the needs of the pharmaceutical and biopharmaceutical industries.

Our brands of cGMP manufactured and compendial products are PharmaPUR® and MultiPUR®.

  • PharmaPUR® — cGMP-manufactured chemicals, cGMP-manufactured solutions and blends, and products with single compendial designations.
  • MultiPUR® — Regulated compendial chemicals that are cGMP-manufactured and meet more than one compendia such as any product that is USP/NF and meets EP, BP, or JP.

If you need to reduce your internal costs of manufacturing, improve your supply chain security or minimize the risks of your supply chain, you can rely on Puritan Products. In business for over 28 years, our processes have been challenged by some of the world’s largest companies and our confidence comes from knowing that we have consistently met or exceeded their demanding requirements.

Puritan Products provides you with peace of mind: documented, traceable processes and supply chains, management of change with notification, and flexible risk mitigation planning. As a cGMP compliant and FDA registered and inspected company, we understand your needs and have the capabilities to manufacture the products you need for your critical applications. Our quality systems have been proven time and again with a 100% successful audit rate by many of the top Fortune 500 pharmaceutical companies.

If you are looking for a supplier who prides itself on being responsive, reliable, and easy to do business with, then choose Puritan Products. At Puritan Products, we leverage our vast analytical capabilities and extensive quality management systems to ensure that your products are consistent from lot-to-lot and year-to-year.

Get what you want, how you want it, when you want it. It’s just that simple.

What does this mean to you?

  • Peace of Mind: Documented, traceable processes, supply chain security, management of change (MOC) with notification, and flexible risk mitigation planning.
  • Understanding your needs: The experience in manufacturing the products you need for your critical applications with all of the necessary documentation and traceability.
  • Proven: Our quality systems have been proven time and again with a 100% successful audit rate by many of the top Fortune 500 pharmaceutical companies as well as by the FDA. These audits help us keep up with industry needs and facilitate continuous improvements.
  • Service: Responsive, Reliable, Flexible
  • Analysis: Analytical capabilities in concert with our quality management systems to ensure your products are consistent from lot-to-lot and year-to-year.
  • Confidence: Full regulatory compliance. Each and every one of our employees receives detailed annual training on cGMP. In business for over 28 years, our processes have been challenged by some of the world’s largest companies and our confidence comes from knowing that we have consistently met or exceeded their demanding requirements.

We encourage you to review our comprehensive Quality Overview, designed as a self-audit, prepared by our Director of Quality using questions routinely received from customer and regulatory agent audits. This audit will provide you with a glimpse into our Quality Management System and answer many of your questions—from both an ISO and cGMP perspective.

Quality Overview Self Audit

cGMP Manufacturing Form

Thank you for your interest in our Sodium Hydroxide Solutions. To start qualifying any of these products or for more information, please fill out the form below and one of our knowledgeable sales staff will contact you within one business day.

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