The preclinical contract research organization Absorption Systems, a global leader in pharmacokinetic testing of drugs, announces that it has entered into a partnership with the Indian pharmaceutical consulting firm Synerzys Lifecare Pvt Ltd. The intent of the partnership is two-fold: to sell Absorption Systems' services in India and, more broadly, to expand the use of the Biopharmaceutics Classification System (BCS) throughout the world.
The BCS, first implemented by the US Food and Drug Administration (USFDA) in 2000, is a scientifically sound regulatory pathway that classifies drugs in such a way as to eliminate the need for human testing or provide further scientific evidence supporting human testing. As a result, drug sponsors can save significant time and money in the development of their products, especially for generics. For developing nations in general, it also means that more-affordable generic drugs can be made available sooner to patients who need them but cannot afford most new drugs. Regulatory authorities around the world are embracing the BCS in various capacities, and as the dissemination of more scientific evidence emerges the drive to further embrace the BCS is clear.
Absorption Systems is the world leader in the measurement of drug permeability for BCS classification. As a result, the company has been audited several times by the USFDA and is registered with the agency as a GDUFA (Generic Drug User Fee Amendments) testing facility. In spite of the trend of American drug companies outsourcing drug research, manufacturing, and clinical trials to China and India, Absorption Systems has established a growing business in the opposite direction. Expertise has no boundaries.
Synerzys is a pharmaceutical consulting and advisory firm based in Mumbai, India. Its team has broad experience in all aspects of drug development and strong connections with all major Indian drug companies. Synerzys is ideally situated due to the fact that India is the world's fourth-largest producer of pharmaceuticals by volume, accounting for roughly 8% of global production. Of the 2,244 abbreviated new drug applications (generics) approved by the USFDA in the 5-year period from 2007-2011, 31% (694) were for Indian sponsors.
Patrick Dentinger, President and CEO of Absorption Systems, commented that, "The growing acceptance of the BCS has created the need for a more strategic view of India. In the low-margin, first-to-file world of generic drug products, companies will either use the BCS approach or compete with it."
Kaushal Shah, COO of Synerzys, added, "We are very happy to partner with Absorption Systems in an endeavour that has the potential for mutual commercial success as well as real benefits to patients in many countries."