It is difficult to predict how long pricing pressures in the US market will continue, according to K Satish Reddy, Chairman, Dr Reddy’s Laboratories Ltd.

In a joint letter to the investors along with Co-Chairman and CEO GV Prasad, Reddy said the company’s task is to overcome this reality.

“The only way of doing so is to have a strong pipeline of difficult to manufacture complex formulations that address key therapeutic needs,” he said, adding that such launches should step-up to combat the price erosion in some products.

During FY2018, the Hyderabad-based drug-maker filed 19 new Abbreviated New Drug Applications (ANDAs) and new drug application with the US Food and Drug Administration (USFDA).

As on March 31, 2018, the company had 110 generic filings pending approval from the US regulator comprising 107 ANDAs and three NDAs. “Out of these 107, 63 are Para IV of which we believe 30 have first-to-file status,” he said.

Regulatory issues

While saying that the company was “fully committed” to standards of quality, Reddy said in the recent past the company had “significantly enhanced” the standards and procedures.

It has also requested the USFDA to schedule an inspection of the oncology formulation manufacturing facility at Duvvada.

Dr Reddy’s sees opportunities in the emerging markets which are now on the long-term upswing.

“We should be able to increase revenues from these geographies through greater sales of simple and complex generics as well as hospital and institutional sales of oncological biosimilars,’’ he said.

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