The Chennai based bulk drug and contract research solution major Shasun Chemicals and Drugs Limited (SCDL) is likely to complete its ongoing Rs. 125 crore investment process for capacity development and R&D capabilities by next year end with a view to become a pharma conglomerate by year 2009, growing through vertical integration and leveraging the core competencies.
Growth strategy
The growth strategy of Shaun is multi-pronged and encompasses almost all main spheres of the pharmaceutical business. Company authorities say while bulk drugs and its derivatives would continue to be a main stay of the business in addition to the other revenue streams, Shasun would offer its vast experience, R& D capabilities, cGMP manufacturing facilities and cost-effective solutions for global pharma players to outsource services as part of the growth process. While the strategy for bulk drugs will be to offer finished dosage forms instead of developing own brands, the formulation business will revolve around multiple products for contract manufacturing.
CRM
Dedicated infrastructure and workforce has been created for contract research, done through Custom Synthesis Model and Contract Research Full Time Equivalent (FTE) programmes. The company already provides CRM activities to four global pharma majors, and negotiations are on with many other companies. Shasun has allied with three other companies to form a consortium - Life Sciences Alliance, along with a US based marketing and logistics partner to offer CRM capabilities. Since the major pharma companies in the west was likely to focus on research and drug development in future, the Indian companies having quality infrastructure and capacities would be able to grow through outsourcing, and Shasun would be in an advantageous position in this aspect, hope Shasun authorities.
Knowledge Management Centre
The Rs.234 crore odd SCDL hopes it could complete the first phase of the Rs 35 crore invested Knowledge Management Centre, a modern USFDA and EU complainant R&D centre coming up at Keelakottaiyur near Chennai ready by December, this year. The first phase is envisaged to accommodate all the R&D activities undertaken at the current Velachery premises of Shasun. Spread on an area of 8.74 acres, the facility envisages eight labs with quality control and analytical labs in the organic block, quality assurance and administration block, three cGMP complainant scalable kilo labs to carry out large-scale experiments, services and utility block, and zero effluent ETP facilities. The centre will have about 250 R& D personnel, instead of the present 90 people working in the
R& D labs.
Largest producer of ibuprofen
Shasun is the largest manufacturer of Ibuprofen in the world, and caters to 50 per cent of the domestic market. It contributes more than half of Shasun's overall sales turnover. The company is in the process of strengthening its presence in the US and European regulated markets with its main API ibuprofen. Company sources say the product has a growth rate of about 10 to 15 per cent every year in the US market for the last two years, and anticipates the growth rate to reach 30 to 35 per cent share of US market by next three years. Shasun estimates ibuprofen business will have a steady 10 to 12 per cent growth in the domestic market. However, the company is likely to exit in future from supplying ibuprofen to the small-scale domestic retail market.
New drugs
Shasun has filed Drug Master Files (DMF) with USFDA for two new APIs: Cox 2- inhibitor, an analgesic and pain management molecule and EIsradipin, a calcium beta-blocker in the cardio-vascular segment. Shasun is expected to be the only manufacturer and marketer globally for the cox-2 inhibitor and is believed to be the only filer of this particular drug so far in USA (filed in November 2003). Cox -2 inhibitor is expected to be in pre-generic or generic mode within the next 18 to 24 months.
Shasun has commenced commercial supplies of EIsradipin since August 2003 to the licensee of the innovator company for the US market. DMF for both the drugs were filed by adopting the non-infringing process. Shasun is expected to file more DMFs soon.
Shasun, which manufactures eight APIs is also working on some more molecules aimed to hit the markets within a few years. Shasun has secured the IP rights for Streptokizine a clot bluster drug, innovated under sponsorship programme 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. 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.