PRINCETON, N.J. — Dr. Reddy’s path to excelling in the manufacture of complex generics and biosimilars depends on its successful filing for new drugs — be these formulations or active pharmaceutical ingredients (APIs).
In fiscal 2020, the company filed eight new Abbreviated New Drug Applications (ANDAs) with the Food and Drug Administration. As of March 31, Dr. Reddy’s had 99 generic filings pending approval from the FDA, consisting of 97 ANDAs and two New Drug Applications (NDAs). It believes that 30 of the ANDAs have First to File status.
The company also filed 98 Drug Master Files worldwide for APIs during the fiscal year, including 10 in the U.S.
In the face of the coronavirus pandemic, Dr. Reddy’s has risen to the occasion with timely and proactive initiatives supported by its strong digital infrastructure.
“Well before COVID-19, we had been working at rapidly building various digital platforms not only across our businesses but also with our suppliers, buyers and doctors,” said K. Satish Reddy, chairman, and G.V. Prasad, cochairman and managing director. “Thanks to this digital backbone, we managed to continue most of our business operations despite the initial challenges. Going forward, we will be using our digital channels even more actively to enable working from home and to reach out to doctors, customers and vendors.”
A range of measures have been undertaken to ensure that manufacturing operations continue unhampered. Across all manufacturing and R&D facilities, offices and canteens, Dr. Reddy’s rigorously imposed social distancing, masks at work and frequent hand sanitizing.
In the initial period, the company experienced two opposite developments. On the one hand, there were incremental sales in certain markets, including the U.S., as a result of stockpiling of medications. On the other hand, some sales were deferred in the API business, and in India and a few emerging markets. “Overall, however, there was no major impact of the pandemic on either in Q4 FY2020 or the full year,” said Reddy and Prasad. “Equally, there is no denying that we may face many COVID-19-related uncertainties in FY2021.”
Pharmaceutical players worldwide have been hugely dependent on China for their supply of intermediates and APIs, but Reddy and Prasad believe this will change. Global drug makers will want to reduce their dependence on China, and there ought to be more backward integration as companies attempt to establish themselves as end-to-end manufacturers. Here, Dr. Reddy’s has an advantage, thanks to its significant in-house API facilities.
The company also expects to see greater outlays in preventive health care and for public health emergencies. While that is good for all nations, it is not certain how it will directly benefit pharmaceutical companies. And if the pandemic continues for several more months there will be increasing delays in the treatment of other diseases. Hospitals and nursing homes all have already begun to push back admission of non-COVID-19 patients. Delays could lead to worsening health conditions, as well as reduced demand for o-face interaction between medical representatives and doctors. Given its importance, one might see some negative impact on pharmaceutical sales. Here, Dr. Reddy’s is at an advantage, given its strong digital platforms.
Despite these significant uncertainties, Reddy and Prasad believe that successful execution of the company’s strategy — leadership in chosen spaces, operational excellence, continuous improvement and patient-centric product innovation — “will create the necessary levers to deal with this uncertain business environment.”
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Chief Executive Officer, North America Generics
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