Alkem seeks partnerships and licensing agreements to strengthen its presence in the American market

Alkem Laboratories’ new manufacturing facility in Indore awaits USFDA pre-inspection.

Pharmaceutical company Alkem Laboratories is considering partnerships and licensing agreements in the United States to strengthen its presence in the world’s largest pharmaceutical market. The Mumbai-based pharmaceutical company also remains positive about the company’s growth prospects in the domestic market with better access to healthcare facilities and growing medical insurance penetration expected to be key growth drivers.

“The company would also strategically review licensing opportunities, alliances and partnerships to enhance its capabilities and product portfolio, gaining more leeway for growth in the US market,” Alkem Laboratories said in its annual report for 2020-2021.

Despite the persistent challenges of price deflation due to increased competition and evolving regulatory controls, the company is confident it is countering them with regular and timely new product launches, the company informed its shareholders.

The pharmaceutical company said it has a healthy pipeline of more than 150 Abbreviated New Drug Applications (ANDAs) filed with the United States Food and Drug Administration (USFDA) with a good mix of Para IV opportunities. and first to file (FTF), which gives it good visibility of growth over the next few years.

In addition, in the medium to long term, the company’s investment in the areas of control substances from its US facilities and biosimilars through its subsidiary in Enzene will also help drive growth, he noted. “We have a strong biosimilar pipeline in the pipeline. This transformation of our product portfolio, while allowing us to deliver the products our patients need, also adds a longer term growth path for our business with the adoption of biosimilars expected to increase in the years to come ” , said Alkem Laboratories General Manager Sandeep Singh.

With a strong pipeline of cases pending approval, there is a significant opportunity to grow the company’s business in the United States in the years to come, he added.

Elaborating on comments received by its St. Louis plant from the US health regulator, Singh noted, “We are in the process of submitting our detailed response illustrating the corrective and preventive actions taken to ensure this plant can continue to remain compliant. with the directives of the CGMP.

He added that the company’s new manufacturing facility in Indore is awaiting USFDA pre-inspection. Developing in other international markets, the company said it is strengthening its position by focusing on selected markets and expanding its operations by creating a strong local presence and offering differentiated products.

Alkem is also open to strategic acquisitions and partnership agreements for the granting and licensing of products in order to capture greater market share, he added. Acquiring new customers, introducing new products and winning commensurate market share in existing products will remain growth drivers, the drugmaker said.

The company’s global footprint spans 40 international markets, in addition to India and the United States, with its key markets being Chile, Australia, Kazakhstan and the Philippines. In recent years, the share of international trade in the company’s overall turnover has increased considerably; it went from 17.4% in fiscal year 2012-2013 to 34.3% in fiscal year 2020-21.

One of the main engines of growth in international trade has been the US market, which has more than doubled in the past four years, Alkem noted. In fiscal year 2020-21, the company’s US operations recorded revenue of Rs 2,466 crore, compared to Rs 2,200 crore in the previous fiscal year, recording a growth of 12, 1%.

Commenting on the domestic market, the pharmaceutical company noted that despite the short-term impact of the COVID-19 pandemic, the future looks bright for the Indian pharmaceutical industry.

“Favorable demographics, growing disposable income, a sedentary lifestyle leading to an increasing incidence of lifestyle-related diseases, better access to healthcare facilities and increasing penetration of medical insurance are key growth factors.” , did he declare. These, coupled with low-cost production, high R&D capabilities and the availability of a skilled workforce, have the potential to catapult the industry to the next level, the pharmaceutical company said. .

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