Hikal Limited, a leading API player with strengths in chemistry research in India has invested about Rs 25 crore as a part of its expansion plans in Bangalore. The plan includes commissioning a new facility for API production, upgrading of two existing manufacturing facilities and constructing a new cGMP pilot plant.

The investments come in the wake of the company's aggressive strategies to showcase its contract manufacture capabilities as global pharmaceutical majors are now keen to outsource custom synthesis of drugs and intermediates developed abroad to save cost and time. Hikal also plans to grab substantial orders in contract research in chemistry from international companies, Dr. K Nagarajan, corporate advisor, R&D Hikal Limited told Pharmabiz.com.

The new ISO 9001 compliant, WHO GMP and TGA (Australia) approved API production facility is now awaiting US FDA certification. The dedicated contract-manufacturing unit will produce generic and would-be-generic molecules with non-infringing patents
and in post 2005, hopefully, branded drugs under patent for multinational companies (MNCs) will be manufactured.

The existing multi-purpose API plant located at Jigani in the outskirts of Bangalore are highly automated and equipped with modern analytical instruments to manufacture complex drugs including those involving chiral chemistry and advanced intermediates for international customers.

The ISO 9001 accredited research centre on the Bannerghatta Road in Bangalore has 30 scientists under the supervision of Dr. I.V. Sankar and is working for in-house needs and global contract research assignments on process development of APIs and intermediates involving multi-step synthesis, chiral chemistry etc. Formulation development activity is also being taken up.

The Centre has a full-fledged pilot plant which has been upgraded to GMP standards and provided with a cryogenic facility with a fresh investment of around Rs. 50 lakh. Hikal has spent close to Rs. 1 crore for a sophisticated NMR instrument and budgeted a
similar sum in 2004 for LCMS equipment.

The new cGMP Kilo Lab to be commissioned in mid-2004 at its research center campus is expected to give a fillip to its contract research programme as when MNCs develop compounds, they require kilograms of materials manufactured under cGMP standards which they now want to outsource, e.g. from Hikal, to avoid the huge cost they would incur in making them in-house. Hikal has gauged the business potential in the area to attract such contract research jobs, which generate substantial revenues, Dr. Nagarajan explained.

Another offering by the company is the concept of Full Time Employees (FTE) for custom synthesis in chemical compounds as MNCs are on the look out for labs with good expertise and supervision. A new facility set up at the Research Centre at a cost of Rs. 80 lakh will now work for two US-based MNCs on FTE basis, informed Dr. Nagarajan.

All along Hikal was only in contract manufacturing; now after upgrading its research facility, it already has a New Chemical Entity (NCE) programme because of its expertise in synthetic medicinal chemistry and the opportunity for collaboration with a national facility in biological sciences.

Hikal, headed by Jai Hiremath, started off as an agro chemical company and entered the pharmaceutical arena in 2001. In 2003-2004, the Group turnover is projected to be Rs. 150 crore out of which pharmaceutical sales would be Rs. 30 crore where of over 6 percent is invested into pharma research and development.