Dr Reddy's Laboratories received the establishment inspection report (EIR) from US Food and Drug Administration (USFDA) for the inspection conducted at the company's formulations manufacturing plant in Duvvada, Visakhapatnam.
The receipt of the EIR indicates the closure of the USFDA's audit at the said facility, the company said after trading hours on Thursday, 20 February 2020.
On 20 August 2019, the company had announced that the US drug regulator had issued a Form 483 with 8 observations for the inspected conducted at the said facility.
The drug maker had informed on 16 August 2020 that the inspection classification of the facility located at Duvvada has been determined as voluntary action initiated (VAI).
Shares of Dr Reddy's Laboratories were currently down 0.65% at Rs 3235.35.
Dr Reddy's Laboratories is an integrated pharmaceutical company. Through its three businesses - pharmaceutical services & active ingredients, global generics and proprietary products - Dr. Reddy's offers a portfolio of products and services including APls, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology and the company operates in markets across the globe.
The drug maker's reported a consolidated net loss of Rs 538.40 crore in Q3 December 2019 as compared to a net profit of Rs 500.30 crore in Q3 December 2018. Net sales rose 13.9% to Rs 4383.80 crore in Q3 December 2019 over Q3 December 2018.
Co-chairman and MD GV Prasad had informed, "The profits were impacted due to trigger based impairment charge taken on a few products including gNuvaring. We continue to focus on execution and have made significant progress on quality systems and operational efficiencies."
Powered by Capital Market - Live News
Disclaimer: No Business Standard Journalist was involved in creation of this content
