About McGuff Pharmaceuticals, Inc.

It is an immutable law in business that words are words, explanations are explanations, promises are promises, but only performance is reality.

– Harold Geneen

Contract Manufacturing

Why Choose McGuff

Our current FDA Inspection Classification is "No Action Indicated (NAI)". An NAI inspection classification occurs when no objectionable conditions or practices were found during the inspection or the significance of the documented objectionable conditions found does not justify further actions.

At McGuff Pharmaceuticals, we listen to you first. Success of any outsourcing project depends on a close, flexible relationship between both parties at the highest levels to achieve mutual success. We have a proven capability of developing a process that is robust, transferable, and scalable to meet your contract manufacturing requirements.

We focus on quality and compliance. These topics are now "top of mind" across the industry. The bar is being set higher for every pharmaceutical manufacturer and especially sterile fill pharmaceutical manufacturers. FDA and EMA have created a working environment that is witness to daily changes in regulations and guidelines resulting in increased costs and pharmaceutical plant closures.

McGuff Pharmaceuticals has a well-established facility and standard operating procedures to meet both cGMP and ISO 9001:2008 requirements. Our policies and procedures encompass all of the training, validation, manufacturing and testing that provide our drug manufacturing outsource customers a cohesive regulatory compliance environment they can trust.

As your contract manufacturing organization, McGuff Pharmaceuticals can leverage its capital investment and investment in human resources to reduce your cost, time-to-market and risk to bring a new drug to market or to maintain your current product.

McGuff Pharmaceuticals can also provide our knowledge in regulatory affairs and the facility/production capability to submit ANDAs on your behalf.

McGuff Pharmaceuticals is much more than a "white powder, white pill" Contract Manufacturing Organization. We offer many services that other Contract Manufacturing Organizations do not.

Learn more about the contract manufacturing services we provide.

We are here to help. Let us show you how.

Additional Information Request

Thank you for contacting McGuff Pharmaceuticals, Inc.

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Please call (800) 603-4795 with any immediate questions.