Ajanta Pharma today said it is focusing on creating a presence in the US by selecting niche and complex products in the oral solid space and plans to file over a dozen ANDAs with the regulator in the world's largest pharma market.
The Indian drugmaker said it plans to file 12-15 ANDAs (abbreviated new drug Applications) with the United States Food & Drug Administration (USFDA) in FY18.
"Our growth aspirations have inspired us to expand our presence to large and complex marketplaces that provide profitable opportunities. We have focused on creating a presence in the US by selecting niche and complex products in the oral solid space.
"We have filed 34 ANDAs of which we have received 17 final approvals and two tentative approvals. We are awaiting approvals for 15 ANDAs and plan to file 12-15 ANDAs in FY18 with the USFDA," the company disclosed in its annual report.
The company's exports grew at 12 per cent during FY17, driven by strong growth in the US market.
The strategy of the company of diversifying in different markets has helped it to maintain the growth momentum even after a subdued expansion in Africa and negative growth in Asia, the report said.
Ajanta Pharma said it has also established a strong presence in rest of Asia and Africa in branded generics business. Our major segments are anti-malaria, anti-bacterial, cardiovascular, orthopaedic, gynaecology and paediatric, among others.
The company said it had successfully entered the Philippines market six years ago and delivered a CAGR of 32 per cent over five years, driven by new product launches and increased traction in existing products.
The company said it is also strengthening its presence in the domestic market.
With focus on new drug delivery system (NDDS) and around 250-plus actively marketed brands, the company focuses on speciality therapies and niche products. It has registered CAGR of 25.6 per cent in branded generic business during FY 2013-17, the report said.
The company was able to grow its revenues from Rs 942 crore in FY13 to Rs 2,026 crore in FY17, at CAGR of 21 per cent.
During FY17, the drugmaker launched 25 products in the domestic market. A strong pipeline of products is in the offing in line with the company's plan, the report added.
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