Red River

National Leadership in Medical Food
Development and Manufacturing

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Production

 

Case Studies

FDA Inspections and Compliance
"We envision compliance enforcement as the next big wave of change
Within food, Drug and Dietary Supplement manufacturing."

- Charlie Wiggins, CEO, Red River Pharma

Our plant has been inspected by the FDA. We've had no 483 observations and are completely 111 CFR, 210 CFR and 211 CFR compliant. We also operate with full e-pedigree capabilities. Red River Pharma hasn't waited to correct problems – we've invested our time and resources to be successfully positioned out in fornt of regulatory change. Several companies have contacted us simply because their traditional manufacturing sources have fallen behind the new era of regulatory enforcement. This will be a competitive advantage for the next decade.

Solving the Mystery of a “New” Ingredient
"When Cerefolin wanted to add N-acetylcysteine (NAC), we faced one tremendous challenge – no one knew how it would react with L-methylfolate."

- Dale Scotten, VP, Red River Pharma

A proprietary ingredient can present a wildcard challenge when considering new formulations. NAC itself was a challeneg as a large, coarse (like sugar) active that needed significant compression. Further, we faced a sulphur component that could create an odor risk. Finally, we needed to understand and master the risk of interaction degradation between the actives. We were able to achieve the proper rate of disintegration while masking the odor properties and achieving a very stable final product. The client was thrilled and the product has become the sales leader in their brand family.

New Product Development
"We've delivered new products to market ahead of schedule regardless of the active ingredient profile."

- Dale Scotten, VP, Red River Pharma

New products always carry a degree of uncertainty...and a desire to accelerate the launch schedule. We work with a lean staff that maintains a keen focus to compress working timelines. In many cases, we've completed the process in half the normal market expectation. (i.e. 6 months rather than a full year from concept to market launch). In this way, our competitive advantage can become your competitive advantage.

Methods Development
“The making of a quality tablet is a true art form, and multiple actives present unique challenges. Not everything is compressible.”

- Charlie Wiggins, CEO, Red River Pharma

Testing for multiple "actives" is always difficult. Perhaps no example is more complicated than a prenatal vitamin with more than a dozen active ingredients and another dozen inactive ingredients. Recently RRP was asked to incorporate new (previously unused, untested) proprietary ingredients to an established prenatal formula. The result was not only success during bench analysis – the product has also become a national leader in market sales.