New Delhi: Dr Reddy’s Laboratories expects to launch over 15 products in the US market in 2018-19, according to a top company official.
The Hyderabad-based drug major also remains optimistic for a double-digit growth in the domestic market in the ongoing financial year.
“Normally every year, based on our portfolio and R&D investments, we prepare for 10 to 15 launches. But this year (2018-19), it could be 15 plus,” the company’s CFO Saumen Chakraborty told analysts in a call.
The company, which launched three products in the US during March quarter of 2017-18, has over 100 abbreviated new drug applications (ANDAs) lined up for approval with the US Food and Drug Administration (USFDA).
“We have over 100 ANDAs pending, many of them first-to-file, many of them complex assets, both at the API level as well as the finished dosage level,” CEO GV Prasad said.
When asked about steps being taken by the company regarding regulatory issues at its two sites, Prasad said FDA has asked drug maker for information on Srikakulam (Andhra Pradesh) facility.
“We are working on providing that back. We hope to complete the request in June. And after that, we have to talk to them about going forward,” he said.
Regarding the company’s formulation manufacturing facility at Duvvada in Visakhapatnam, Prasad said: “The Duvvada site has to be inspected. We have done a lot of remediation work and the inspection request will go to them at the end of June or early July and then we will await a reinspection.”
Commenting on the company’s India operations, COO Erez Israeli said the drugmaker is witnessing progressive improvement in the business performance over the last few quarters.
“We strive to perform better than the market through 2018-19. Overall, we remain optimistic towards the double-digit growth rate in the current financial year,” he said.
The company generated revenues of Rs 2,332.2 crore from domestic business in 2017-18.