DST is a technology transfer firm with unique expertise in pharmaceutical and biotechnological product development, with a well defined strategy to tap into USA market. DST is engaged in investing into joint ventures with global generic drug manufacturers based on well structured scope and responsibilities. We partner with global pharmaceutical manufacturing companies and under a joint venture, we submit generic drug applications for USFDA approval.
DST investment comprises managing the ANDA process from start to finish, guiding and facilitating the partner plant’s USFDA certification, managing overall Quality for selected medicines. Moreover, DST oversees partner plant's manufacturing process of the subject drugs for the USA market while enabling global distributorship of their approved drugs.
DST is staffed by professionals with years of progressive working experience in USFDA regulatory environment, including extensive generic drug approval experience.
Our focus:
Sterile Injectables Pharmaceutical and biotechnology companies’ investments and innovation are yielding more promising treatments.Scientific breakthroughs, as well as regulatory approvals, have increased competition among a growing number of treatments, formulations, branded drugs and generic products.
Drug Shortages:
According to the FDA, in 2010, in the US, the top five manufacturers accounted for 80 percent of the volume of sterile drugs, and the top three alone accounted for 71 percent. Further, 342 of 569 sterile injectable drugs — 60 percent — were virtually single-sourced, with one supplier accounting for at least 90 percent of supply. With only six of the 569 drugs did the top two suppliers account for less than 50 percent of the supply.
More than half the critical drug shortages reported between Jan. 1, 2009, and June 20, 2011, involved generic injectable drugs. This is counterintuitive. A generic medicine is allowed on the market only after patents on the originally invented medicine that the generic copies have expired. (Mackinac Center for Public Policy, June 14, 2012).
Other Injectables
Currently manufactured products
Where applicable, DST will work with companies to gain USFDA approval for their manufactured product currently distributed outside the USA.
New product portfolio
Both DST and the manufacturer will bring potential products to the table that would add not only profitability but gain both US market share and growth to the company.