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Custom Formulation Development

Process Development. Pilot Scale Production. Transfer and Scale Up.

CustomFormulationDevelopment

US Pharma Lab specializes in identifying and providing the solutions needed for any custom formulation challenge.  A verified assay accompanies each granulation formula, delivering on the promise of meeting all active ingredient claims and FDA product compliance standards.

The formulation team understands the product-development process and carefully analyzes the qualities of each ingredient before the formula is written.  This allows them to identify potentially problematic ingredients early on in the process that can lead to troublesome properties such as stickiness during production.

The process begins with a reputable raw material supplier. The Procurement department has solid relationships with a handful of suppliers from around the world. Because all raw materials received by US Pharma Lab are able to be traced back to their origin, each supplying vendor is held accountable to the highest standards. This ensures product compliance and ingredient uniformity for each batch of raw materials received.

Once a batch of raw materials enters US Pharma Lab, it goes through a series of rigorous steps to meet the strict requirements of the FDA.  Our in-house QA/QC laboratories are run by a team of accredited scientists who use the most modern instrumentation. In line with FDA guidelines, they perform the full range of assay testing required for each batch of raw materials received.

US Pharma Lab’s Formulation Scientists are experts at tackling a variety of granulation challenges. Working in partnership with each client, the R&D department provides the right solutions needed to deliver directly compressible granulations with a uniform distribution of active ingredients, even at the micro-nutrient level.

Special attention is given to inter-ingredient interactions when including multiple actives into high-speed press formulas. US Pharma Lab’s strategy is to improve powder flow and compression for dosage forms.  This promotes efficiency and productivity while running high speed presses, leading to accelerated commercialization.