 "US market offers opportunity to grow rapidly: Rajesh Agrawal")
Ajanta Pharma, the Rs 840-crore domestic pharmaceuticals major, has planned a slow and steady entry into the US market, beginning a year earlier. Ranked 45th in Indian pharma, it has strong presence in the areas of ophthalmology, dermatology and cardiology. Rajesh Agrawal, joint managing director, speaks to Reghu Balakrishnan on the plan for raising the presence abroad. Edited excerpts:
What’s the latest update on ANDA submissions in the US with the FDA (the regulator)?
We have filed 15 abbreviated new drug applications (ANDAs) as on date, of which two are approved. These two belong to the therapeutic segment of CNS (central nervous system), anti-depression and anti-psychiatric. For the generics, the focus on the therapeutic segment is not so relevant. Currently, our focus is on solid dosage forms – tablets, capsules and powders. Our product portfolio is a blend of high-volume basic generics and niche products, difficult to develop and manufacture.
Was there a delay in entering the US market?
Ajanta always aspired to be part of the world’s largest pharma market, the US. After creating an outstanding brand image in the domestic as well as many emerging markets of Asia, Africa and Latin America, the company saw itself in a position to take the next leap. Besides, the US pharma market offers an opportunity to grow rapidly for any company which is able to overcome the associated challenges.
What are the marketing plans there?
For our first product launch, we have tied up with Breckenridge Pharmaceutical for marketing our product. We have also set up our front-end sales and marketing team in the US. All product approvals that we receive hereafter will be commercialised by us through our own team.
What’s the US revenue expectation in the next two-three years?
We would not like to put a number yet on sales and profits. The US market will add to our balance sheet, as we are in the initial stage of setting up and getting ANDA approvals. We expect revenue from the US in the current year to be very small, in view of only one product being available in the market. However, it should pick up early next year, with a few additional approvals in hand. We estimate that in the next three to five years, once we have a decent number of 10-12 products approved by the FDA, we should see significant contribution from the US. Five years down the line, we expect to see Ajanta anchoring itself firmly in this important market.
What are the future strategies in the US market?
We are targeting a minimum of five-six ANDAs every financial year and look forward to be one of the meaningful players in the years to come. We are expecting two to three 3 ANDA approvals in the current year and some more in the next year.
We already have one FDA-approved manufacturing facility in Aurangabad and are building one more dedicated facility in Gujarat, at an investment of about Rs 200 crore. This will ensure availability of manufacturing capacities to meet the growth requirement of the US market.
Plans in other global markets?
We are an established player in emerging markets, with presence in a little more than 35 countries spread across Africa, Asia and Latin America. About 65 per cent of the present revenue is generated from international business, most of which is sustainable branded generics. The strategy is to increase business from existing markets by increasing the market share from existing products and new products awaiting approval. Our focus on Europe at this point is limited to one product approval we have and our manufacturing facility is approved by the UK MHRA (the country drug regulator).
What’s the latest update on ANDA submissions in the US with the FDA (the regulator)?
We have filed 15 abbreviated new drug applications (ANDAs) as on date, of which two are approved. These two belong to the therapeutic segment of CNS (central nervous system), anti-depression and anti-psychiatric. For the generics, the focus on the therapeutic segment is not so relevant. Currently, our focus is on solid dosage forms – tablets, capsules and powders. Our product portfolio is a blend of high-volume basic generics and niche products, difficult to develop and manufacture.
Was there a delay in entering the US market?
Ajanta always aspired to be part of the world’s largest pharma market, the US. After creating an outstanding brand image in the domestic as well as many emerging markets of Asia, Africa and Latin America, the company saw itself in a position to take the next leap. Besides, the US pharma market offers an opportunity to grow rapidly for any company which is able to overcome the associated challenges.
What are the marketing plans there?
For our first product launch, we have tied up with Breckenridge Pharmaceutical for marketing our product. We have also set up our front-end sales and marketing team in the US. All product approvals that we receive hereafter will be commercialised by us through our own team.
What’s the US revenue expectation in the next two-three years?
We would not like to put a number yet on sales and profits. The US market will add to our balance sheet, as we are in the initial stage of setting up and getting ANDA approvals. We expect revenue from the US in the current year to be very small, in view of only one product being available in the market. However, it should pick up early next year, with a few additional approvals in hand. We estimate that in the next three to five years, once we have a decent number of 10-12 products approved by the FDA, we should see significant contribution from the US. Five years down the line, we expect to see Ajanta anchoring itself firmly in this important market.
What are the future strategies in the US market?
We are targeting a minimum of five-six ANDAs every financial year and look forward to be one of the meaningful players in the years to come. We are expecting two to three 3 ANDA approvals in the current year and some more in the next year.
We already have one FDA-approved manufacturing facility in Aurangabad and are building one more dedicated facility in Gujarat, at an investment of about Rs 200 crore. This will ensure availability of manufacturing capacities to meet the growth requirement of the US market.
Plans in other global markets?
We are an established player in emerging markets, with presence in a little more than 35 countries spread across Africa, Asia and Latin America. About 65 per cent of the present revenue is generated from international business, most of which is sustainable branded generics. The strategy is to increase business from existing markets by increasing the market share from existing products and new products awaiting approval. Our focus on Europe at this point is limited to one product approval we have and our manufacturing facility is approved by the UK MHRA (the country drug regulator).
Plans in Indian market? Product launches, inorganic growth plans etc?
We are a strong speciality player with focus on therapeutic segments of ophthalmology, dermatology and cardiology. We are growing much faster than the industry average as well as the average of therapeutic segments wherein we operate. Today about 60% of our portfolio of domestic products is of first time launches in the market. Last year alone we launched 19 products out of which 4 were first to market ahead of the competition. We continue to remain focused on existing three therapeutic segments and launch newer brands with a clear focus to keep increasing the productivity in domestic market.