The role of the contract manufacturer (CM) involves more than manufacturing and supplying ingredients.

The CM plays a critical role producing a compliant quality product for your label that stands up to all regulatory scrutiny and consumer safety parameters. As such, they should function as a reliable extension of your organization.

The real value the CM brings is building a dependable lasting partnership with you and bringing you peace of mind.

Here are valuable questions helping you choose the right Contract Manufacturing Partner.

Pharmachem Laboratories, LLC is seeking new markets for its Phase 2 carb controller ingredient with the North American release of DietSpice, a line of functional seasonings that can be sprinkled on food to help weight watchers absorb fewer calories from the starches in their meals.

Phase 2 is already featured in a number of dietary supplement brands from companies like Now Foods, GNC and The Vitamin Shoppe. DietSpice has already been introduced to the market in Europe, where the Phase 2 ingredient is known as Starchlite, and has also been available in Japan. The plan for the new delivery mode in North America includes co-packaging opportunities in prepared foods such as frozen pizza or mac and cheese, said Pharmachem managing director Mitch Skop.

Since its licensing agreement with Probiotical, S.p.A., Novara, Italy, in 2009, Pharmachem Laboratories, LLC has been able to introduce Microbac™ microencapsulated probiotics into a growing variety of products in virtually every channel of trade, as well as international markets, according to Gregory Bonfilio, business development manager at Pharmachem.

“The future of probiotics is in delivery forms,” says Bonfilio. “Microbac effectively protects the bacteria in a complex formulation from other ingredients that might previously have destroyed the bacteria. This technology enables us to experiment with a much larger number of delivery forms than we were previously able to imagine, including chocolates, sprinkles, chewable tablets and instant beverages.”

The contract manufacturer plays a key role in providing a quality product produced according to cGMPs, one that will stand up to all regulatory scrutiny and consumer safety parameters.

As a raw material contract manufacturer/supplier producing premixes and drum to hopper formulations there are three pathways that a customer can pursue: 1) a total turnkey product; 2) a product where the ingredients/raw materials are customer provided; or 3) a combination of the above.

FDA issued a generally recognized as safe (GRAS) notice to Pharmachem Laboratories, LLC for its Phase 2 Carb Controller® white kidney bean extract.

The FDA notice stated: “Based on the information provided by Pharmachem, as well as other information available to FDA, the agency has no questions at this time regarding Pharmachem’s conclusion that white kidney bean extract is GRAS under the intended conditions of use.”