Biocon has now ventured into new segments within its Active Pharmaceutical Ingredient (API) Strategic Business Unit. The API portfolio now includes ophthalmics, peptides, cytotoxics and Multiple Sclerosis(MS). Globally, these are fast growing segments and they also come with high entry barriers.


The company is in the process of getting qualified in the customers’ filings for regulated markets. It has also submitted dossiers and is the process of getting its approval in the emerging markets for APIs in nephrology space.


The company has set specialized facilities for these products. Though niche, all of these new API segments are high potential ones with a good global potential. The objective is to target the both regulated and emerging markets, Akash Puranik, vice president- Marketing, Biocon Limited told Pharmabiz.


The focus is on APIs which are technology intensive. “Here our R&D expertise together with a comprehension of the regulatory framework help us to establish a global presence. In the bio-pharma space, we are recognized as a high quality manufacturer of technology intensive products. Our product mix and R&D and differentiates our approach to the market, he added.


The range of Ophthalmic APIs are latanoprost, travoprost, bimatoprost, dorzolamide, and brinzolamide.


According to the company, latanoprost and travoprost are a prostaglandin analogue used for controlling the progression of glaucoma or ocular hypertension by reducing intraocular pressure. Biocon is developing a sterile solution for ophthalmic use.


Bimatoprost and dorzolamide are indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. The company is developing sterile solution of various strengths for opthalmic use.


Brinzolamide is a carbonic anhydrase inhibitor used to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Biocon is developing suspension for ophthalmic use.


The existing range of APIs include cholesterol-lowering agents, reversible inhibitor of lipases, immunosuppressive agent and anti diabetic agents continue to garner growth. For Q1, 2011, the bio-pharmaceuticals business registered 7.7 per cent growth with revenues of Rs.354.28 crore.


According to Puranik, APIs in bio-pharma are high growth products but not devoid of challenges. The right products, technologies and quality manufacturing will make the difference.


A new trend is that companies manufacturing formulations are now looking at production of APIs to capitalize on economies-of- scale. The industry is in the process of ramping up infrastructure capacities, increasing investments in R&D and infusing new technologies. Also global chemical and active pharma ingredient manufacturers are keen to have India for the production and research of a range of chemicals and bulk drugs. The country’s chemical and API expertise and competitive pricing are factors driving the opportunities. As a part of cost cutting measures by regulated regions many multinational players have started sourcing bulk drugs from cost competitive destinations and Indian companies have emerged as the preferred supplier for APIs.