Karnataka bulk drug sector is gearing up to keep pace with the growing demand for a range of speciality chemicals in the country and globally. The bulk drug players in the state believe that the active pharmaceutical ingredient (API ) is heart and soul of formulation industry and hence the sector is on a growth trajectory. The state has already seen an investment of over Rs. 100 crore at the Bommasandra Industrial Area in the outskirts of Bangalore off the Hosur Road, which has attracted significant investment in the bulk drug sector.
Among the new API units include Apotex Research Pvt. Ltd., which is part of the Canadian generic pharmaceuticals and drug research company's new research and development unit at an investment cost of Rs, 24.20 crore. The facility is coming up on 8.20 acres at the 4th Phase of the Bommasandra Industrial Area and will employ 240 personnel. Primarily research will be done on the tablets and capsules. Siddhi Vinayaka Spechem Pvt. Ltd. is setting up a bio chemicals production units at an investment of Rs. 12 crore. The unit is coming up on two acre and will employ 140 personnel. Brantford Chemicals has completed almost 90 percent of its construction work.
The favourable factors for the growth of bulk drugs in the country and the in the state are the presence of a vast technical pool, well-established state-of-the-art manufacturing plants, low costs compared to western countries, expressed VR Kannan, pharma consultant.
The current trend for bulk drug sector is that units are seen to gear up to supply intermediates for multinational companies. Another lucrative business is the contract research of active pharmaceutical ingredients (APIs). In the wake of the two potential business opportunities, major expansion plans in the form of new plants and hiring additional scientific personnel are on among large companies in the state.
The major players headquartered in Karnataka - Biocon, Strides Arcolab, Micro Labs, Bal Pharma, RL Fine Chemicals and Resonance which have made a significant presence in the global markets.
The largest API player in the state and the country in the biotechnology sector , Biocon Limited continues to maintain a strong position in APIs for 2005-06 in the area of small and specialised molecules. The focus of the company right from the beginning has been fermentation based biotech products. Apart from its strong statin expertise, it also has diabetology products including insulin which is exported in bulk.
The company's r-human insulin uses proprietary recombinant technology and the product conforms to the highest international standards and specifications. "We are looking at other biologicals products like GCSF, EPO and streptokinase which will be on stream this year because of our new biological facility. We are sticking to our area of cardiology and diabetes apart from a range of immunosuppressants for organ transplants and auto immune diseases in APIs. Biocon has made major investments in statins which is now going off patent in the US and hopes to have a significant position in that market,'' stated Ajay Bharadwaj, president, Marketing Biocon Limited.
To capitalise the advantage of the regulated markets for APIs, the Rs. 500 crore Micro Labs has commenced construction of a dedicated bulk drug facility at Bommasandra in the outskirts of Bangalore on a land allotted by the Karnataka Area Industrial Board (KIADB). Micro has invested around Rs. 25 crore and has received the clearances from the State Pollution Control Board and the Ministry of Forests and Environments in New Delhi for the 'Consent for Establishment'. "The API investment is primarily a backward integration strategy and our strong marketing skills will allow us to enter the regulated regions of Europe and US," informed Suresh Khanna, president API, Micro Labs.
The Rs. 64 crore Bal Pharma is setting up a bulk drug unit on a 5 acre plot at an investment of Rs. 13.40 crore at Bommasandra where around 14 products would be manufactured for the regulated markets, stated Shailesh Siroya, managing director, Bal Pharma.
Hikal Limited, a leading active pharmaceutical ingredient (API) player with strengths in chemistry research in India has invested Rs. 25 crore as a part of its expansion plans in Jigani in the outskirts of Bangalore, which includes a new facility for API production, upgrade two existing facilities and a new contract research facility with a cGMP kilo-lab. "The investments come in the wake of the company's aggressive strategies to enter the regulated markets for its API in the post 2005 and also grab substantial orders in contract research orders from global majors, Dr. K Nagarajan, corporate advisor, R&D Hikal Limited.
The Hikal API facility is a multi-purpose plant capable of handling complex chemistry, chiral chemistry and has been inspected multinational companies for contract manufacture. From this unit, Hikal meets the demand for APIs and advanced intermediates for international customers. An ISO 9001 accredited research centre on the Bannerghatta Road in Bangalore has 30 scientists working for in-house needs and global contract research assignments for synthesis, process development of intermediates and APIs involving multi-step synthesis, chiral chemistry and natural products. In addition, research on pharmaceutical dosage forms and development of analytical methods and instrumentation is also there.