Drug major Aurobindo Pharma is confident of growth in the key US market despite recent hiccups on the regulatory front. The company said that it expected all-round growth in the US market with a significant expansion in the company's injectables portfolio going forward.
Aurobindo Pharma's managing director N Govindrajan said that the optimism was based on the fact that 2018-19 had been a busy year for the company's US team.
Although Govindarajan's letter did not mention USFDA's warning letter dated June 20, 2019, which raised serious cGMP lapses in three of Aurobindo's API and formulation facilities, it stated that the company has a robust compliance framework and a dedicated quality assurance department that ensures complete compliance of its plants with various regulatory requirements.
Earlier, the company said that the impact of regulatory strictures passed on three of its manufacturing facilities will be negligible on US business as it has ample availability of production capacities on other sites to shift product manufacturing. The company added that new product approvals from those plants were also minimal.
"The US business contributed to 46 per cent of our revenue and registered a strong 21 per cent growth during the year at Rs 9,030.7 crore as all our key business segments, including orals, injectables, over the counter(OTC) drugs and dietary supplements performed well. It was a busy year for the US team as we launched 50 new products, including 12 injectables in the market. Also, in 2018-19, we received approvals for 48 abbreviated new drug applications (ANDAs) and filed for a total of 63 ANDAs with the USFDA. While these filings will drive organic growth in the US market, during the year we also had the opportunity to pursue inorganic growth that will help us enter into new therapeutic areas and segments including branded oncology products," Govindarajan said.
Govidarajan attributed the company's continued growth, often higher than its industry peers, on the fact that it was not dependent on a single product, or event, that determines the success of the company. "We are present in multiple geographies, across products, delivery mechanisms and therapeutic areas and our sustained growth over the years is a result of our actions in all these areas," he said.
According to him, the company's ability to produce affordable drugs and enter new therapeutic segments and geographies will be the key factors in expansion across growth markets. To support this growth, the company is investing in expanding capacities. The company commissioned Unit X - a green field oral solid manufacturing facility at Naidupet in Andhra Pradesh with a total installed capacity of 6 billion units annually.
Ranked as the tenth largest generics company globally, Aurobindo had reported Rs 19,563.6 crore in revenues in FY19 with an year-on-year growth of 18.5 per cent. The company is likely to touch the $3 billion revenue mark in the current year if it is able to maintain the double digit growth.