Dr. Reddy's Looking at More Product Launches in US This Fiscal

Dr. Reddy’s Laboratories expects to launch over 15 products in the US market in 2018-19, according to the company’s CFO, Mr. Saumen Chakraborty. “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,” he said.

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,” informed the company’s CEO, Mr. G.V. Prasad.

The Hyderabad-based drug major also remains optimistic for a double-digit growth in the domestic market in the ongoing financial year.

Dr. Reddy’s said the USFDA audit of the company’s API Srikakulam plant (SEZ) located in Andhra Pradesh, has been completed with no observations. Regarding the company’s formulation manufacturing facility at Duvvada in Visakhapatnam, Mr. 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 in the end of June or early July and then we will await a reinspection.”