Dr. Reddy’s Labs Launches Generic In The US; Telangana IPDO Clears USFDA Inspection

Dr. Reddy’s Laboratories on Thursday announced the first generic launch of Naproxen and Esomeprazole Magnesium delayed-release tablets in the US market.

Dr. Reddy’s Laboratories announced the first-to-market launch of Naproxen and Esomeprazole Magnesium delayed-release tablets, a therapeutic equivalent generic version of Vimovo (Naproxen and Esomeprazole Magnesium) delayed-release tablets approved by the US Food and Drug Administration (USFDA).

The Vimovo brand had US sales of approximately $414 million MAT for the most recent twelve months ending in December 2019 according to IQVIA Health.

Dr. Reddy’s Naproxen and Esomeprazole Magnesium delayed-release tablets are available in 375 mg/20 mg and 500 mg/20 mg tablets in bottle count sizes of 60.

In a separate announcement on Thursday, the drug maker announced that the USFDA completed the audit of Integrated Product Development Organization (IPDO) at Medchal-Malkajgiri, Telangana. No Form 483 was issued at the closure of inspection, the company said.

Shares of Dr. Reddy’s Laboratories were up 0.06% at Rs 3077.45. The stock is trading below its 20 days and above its 50 days simple moving averages placed at 3186.31 and 3052.87 respectively. These levels will act as resistance and support levels in near term.

Dr. Reddy’s Laboratories is an India-based pharmaceutical company with headquarters and registered office in Hyderabad, Telangana, India. Through its three businesses – pharmaceutical services and active ingredients, global generics and proprietary products – the company offers a portfolio of products and services, including active pharmaceutical ingredients (API), custom pharmaceutical services (CPI), generics, biosimilars, differentiated formulations and new chemical entities.

On a consolidated basis, the drug major recorded net loss of Rs 569.70 crore in Q3 December 2019 compared with net profit of Rs 485.20 crore in Q3 December 2018. Consolidated revenues rose 14% to 4383.80 crore in Q3 December 2019 over Q3 December 2018.-Business Standard