Outsourcing Generic Formulation Development Can Improve Your Bottom Line

Demand for outsourcing pharmaceutical formulation development and manufacturing is on the rise for drug developers at all levels. The significant number of new innovator drug patents coupled with exclusivity protections expiring or expired has resulted in many products and product categories with limited or no generic competition. This unique combination of events has created significant new opportunities in the generic drug market. Taking advantage of the combination of foresight & marketing research from a strategic partnership with an experienced Contract Development Manufacture Organization (CDMO) will unlock a winning formula to fill these gaps in the generic drug market.

Cost Efficiency of Paramount Importance

The lower profit margins and fierce competition in generics makes cost efficiency of paramount importance. Below is a simplified formulation development process for bringing a generic to market:

  • Characterization of Reference Product
  • Design of Generic Product and Process
  • Pivotal Biobatch
  • Bioequivalence Study
  • Commercial Product Manufacture

Unlike new drugs, total failure to bring a generic drug to market is minimized because the safety and efficacy of an Active Pharmaceutical Ingredient (API) has already been established. However, inefficiencies in the formulation development process will still reduce the bottom line. By partnering with a top quality experienced pharmaceutical CDMO you can minimize this risk. Adding the unique perspective of the CDMO on the pulse of the pharmaceutical markets creates a win win scenario.

Faster, More Efficient with Lower Costs

Most importantly, it is in the CDMO’s best interest to become expert in bottleneck avoidance throughout the entire formulation development process. Top quality CDMO’s have already made the large scale investments in developing & building efficient processes. By building strategies to circumvent costly & duplicative clinical trials, and by recruiting top personnel, experienced with final scale-up for manufacture, pharmaceutical companies are bringing generics to market faster, more efficiently and at a lower cost.

Building a solid relationship with a proven CDMO backed by a positive quality record with regulatory agencies can result in a long term strategic alliance benefiting all parties involved.