In order to further strengthen its presence in the Active Pharmaceutical Ingredient (API) space, Karnataka’s Micro Labs is now spearheading its efforts to file 12 Drug Master Files in the US and seven DMF’s in EU by end of FY 2011.
Presently, Micro Labs has filed seven DMFs in the US and four DMFs in EU. “We are engaged in filing of drug master files of our product in the regulated markets. Since Micro Labs already has a presence in the regulated markets, we intend to develop APIs which will be used internally for our own filings. Apart from the regular products we are also developing niche or complex APIs that would be offered to various strategic partners in the US, EU and Japan”, N Balachandra Shenoy, senior general manager, API, Bommasandra Plant, Micro Labs told Pharmabiz in an email interaction.
Currently, the company is engaged in the production of APIs in segments of Antihistamines, Ophthalmology, Anti-hypertensives, Anti malarial, Anti inflammatory, Anti depressants, Anti diabetics, Anti ulcerant and Nootropics.
Specific to API research, the company is developing and synthesizing compounds of global standards involving innovative and non-infringing process. “Our research focuses on creating core competency in few therapeutic segments involving complex chemistry,” he added.
As part of the corporate social responsibility, Micro Labs has been concentrating considerably in the area of green chemistry efforts in the wake of environmental concerns and global warming. Some of the initiatives being viewed are in the areas of extensive reduction in waste generation, optimization of yields, minimizing and avoiding or substituting metals involved processes. Further, to reduce carbon foot prints, optimum usage of utilities are being assessed and incorporated into process at the development stage itself.
The growing dependence of high quality and fast turnaround sourcing of APIs by the companies in the regulated markets, Micro Labs future strategy in the space would be to develop innovative process which are cost- effective and environment-friendly, maintain the facility compliance to highest regulatory standards, scout for strategic partnership opportunities. This would be supported with increased efforts raising the quality standard bar, service and safety parameters, stated Shenoy.
For the period 2009-10, Micro Labs registered an earning of Rs.1,400 crore, out of which Rs.1,000 crore was accounted from domestic market with remaining coming in from exports.
Commenting on the API industry scenario in India, Shenoy stated that companies here are able to succeed in the market through quality production and research abilities. The increasing scientific capability together with the advanced processes and state-of-the art manufacturing plants have led to a quantum jump in the number of Drug Master Files. Today, India is among the top three manufacturers of API in the world after China and Italy.
The size of API industry is estimated between Rs.32,000 crore to Rs.35,000 crore of the total Rs.78,000 crore Indian pharma sector. Out of the Rs.35,000 crore, almost Rs.18,000 crore comes from exports. The industry has registered around 15 per cent growth both in API and its exports.