The Chennai based pharma major Shasun Chemicals and Drugs Limited (SCDL), one among the leading bulk drug manufacturer and Contract Research And Manufacturing (CRAM) solution provider in India, has filed Drug Master Files (DMF) with US FDA for two new Active Pharmaceutical Ingredients (APIs), and will file more applications in near future.
With the launch of Cox 2- Inhibitor, an analgesic and pain management molecule, Shasun will become the only manufacturer globally to manufacture and market this product. Shasun has filed the DMF for Cox-2 Inhibitor in USA and is believed to be the only filer of this particular drug so far. DMF has been filed by adopting the non-infringing process. It was expected that this drug would be in pre-generic or generic mode within the next 18 to 24 months and DMF for this molecule was filed with US FDA during November 2003, informed S.Vimal Kumar, finance director and N. Govindarajan, chief executive officer of Shasun, in an exclusive talk with Pharmabiz.
Further, the company has already field DMF for EIsradipin, a calcium beta-blocker in the cardio-vascular segment and has commenced commercial supplies since August 2003 to the licensee of the innovator company, for supplies in the US market. Both the molecules will be in pre-generic or generic mode of manufacturing within the next 18 to 24 months. While the former is already off patent, the second will become off patent only by year 2011.
Shasun, which manufactures eight APIs and the largest manufacturer of Ibuprofen in the world, was also working on some more molecules aimed to hit the markets within a few years, said Vimal Kumar and Govindarajan.
They said Shasun has secured the IP rights for Streptokinase, a clot bluster drug, innovated under sponsorship program by IMMTECH, Chandigarh. The drug is currently undergoing pilot trials and validation process after the technology transfer and is likely to be ready for commercial validation and launch within the next 18 to 20 months.
Similarly, Shasun hopes to commercially launch a Multi Drug Resistant (MDR) TB drug by June 2005. The innovator Eli Lilly has transferred the technology about six months ago, and the validation process is going on. DMF for the drug will be filed with US FDA during September 2004.
SCDL, which has technology license from Eastman Chemical Company of USA to manufacture and market excipient Hydroxy Propyl Methyl Cellulose Phthalate (HPMCP) and MAP, has plans to launch more excipients in near future in association with the technology partner, said senior management members.