Who owns the work product, formulas and intellectual property?

Axcentria owns all product formulas and intellectual property unless there is a licensing agreement where we use your formulas and processing protocols.

What are Axcentria’s manufacturing capabilities and capacity?

We can fill any size between 5ml and 480ml, and can manufacture any size from a pilot batch to commercial scale.

Does Axcentria have a documented Quality Management System?

Absolutely! In accordance with cGMP standards we use a SOP system that controls all our business processes.

What is USP?

USP stands for United States Pharmacopeia. This is an official public authority that sets standards for raws materials used in prescription and over–the–counter medicines and other health care products manufactured or sold in the United States.

What is cGMP?

cGMP refers to the current Good Manufacturing Practice regulations devised by the FDA which require that manufacturers, processors and packagers of drugs, medical devices and some foods and beverages take proactive steps to ensure that their products are safe, pure and effective. cGMP regulations require a quality approach to manufacturing, enabling companies to minimize contamination, mix-ups and errors. This is all designed to protect consumers from purchasing products that are not effective or possibly unsafe.

What licenses or certifications does Axcentria hold?

Axcentria is FDA registered (Pharmaceuticals #961871501 and Medical Devices #3008062657) and inspected. Axcentria holds a DEA license.

Do FDA regulations for pharmaceuticals differ for foods, supplements and other products?

There are big differences. FDA pharmaceutical regulations are the highest standards for any of the above categories. Pharmaceutical standards require manufacturers like Axcentria to follow current Good Manufacturing Practice (cGMP), analyze all incoming and finished goods and document all work performed. While foods and supplements also have standards set by the FDA, they are not as rigorous, and don’t require pharmaceutical-level standards for testing or manufacturing.

What is a contract manufacturing services company? What services do you provide?

Axcentria is a full service Contract Manufacturing Organization. That means we can be your “virtual” partner for product development, procurement, manufacturing, product testing, warehousing, inventory management and customer fulfillment.  This gives you the freedom to focus on what’s most important: the marketing and sales of your products.

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