Aurobindo Pharma on track to develop complex products, expand global footprint
The facility will start filing new injectable products in FY23 with earliest possible commercialisation in FY24, the drugmaker added.
Hyderabad: Aurobindo Pharma remains focussed on developing complex and differentiated products in multiple areas comprising oncology, hormonal products, biosimilars, depot injections and vaccines to drive the next phase of growth, as per its Annual Report for 2021-22. The Hyderabad-based firm also said it is in the process of commissioning the capacities for some of the complex therapeutic areas, adding that it is committed to grow in its key geographies of the US, Europe and other growth markets.
"In the US, around 220 abbreviated new drug applications (ANDAs) are awaiting final approval..With the pandemic situation easing, your company will resume its development trajectory, with a focus on developing a product range of complicated injectables," it informed shareholders.
In Europe, the company has filed applications for 58 products and is awaiting approval, the drug major said.
Additionally, there are nearly 200 products under development in general oral/ general/ oncology product categories, which will be launched in the next two to three years.
The drug firm is also building a dedicated injectable facility for Europe and growth markets to strengthen its presence in the hospital segment.
The facility will start filing new injectable products in FY23 with earliest possible commercialisation in FY24, it added.
Aurobindo Pharma Vice Chairman and Managing Director K Nithyananda Reddy said the company has been consistently growing its presence in China, which is one of the largest healthcare markets in the world, besides being a dominant supply base.
"We are creating an oral formulation facility in China and plan to fulfil our international demand apart from domestic contribution. We began local manufacturing in that country from January 2022 and aim to shift 30 products from India into China," he noted.
Of these, two have been approved and the company expects another 10-15 products to receive their approvals in this year, Reddy said.
"We also intend to transfer a few products from Europe to the China facility. With a total target of reaching 40 products in China, if we are successful in realising our plans then there should be significant accretion to both our topline and bottomline spreads," he said.
The company would also continue to drive its injectables business where it envisages strong growth and healthy margins, and a working model that premiumises value addition, he added.
Besides, the biosimilars portfolio growth has been gaining steady momentum, Reddy said.
"In FY22, we filed two oncology biosimilars with the European Medicine Agency. Additionally, three more are at Phase 3 licensure clinical trials stage, of which one is expected to complete these trials by early FY23. As we build our biosimilars pipeline, we are optimistic about the new revenue streams starting in the next 1-2 years," he added.
Reddy said in India, it has been working consistently on the opportunities unleashed by the government's Production Linked Incentive (PLI) scheme, with the penicillin and allied areas throwing up some very attractive prospects.
"We have initiated building capacities in these areas and invested this year (FY22) Rs 2,677.7 million and the total capital for this project is expected to be around Rs 18,500 million to Rs 19,000 million which will help us to significantly enhance our backward integration, make our production value chain more resilient and improve control over costs and sustainable profit margins," he said.
Reddy noted that its strong background in generic formulations has created an overdependence on raw material procurement, input prices and logistical performance -- all of which are factors beyond its control.
"Unpredictability in any of these dimensions can potentially corrode overall growth. We are keen to moderate this impact over time," he said.
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