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Dr. Reddy’s Initiates Process for Emergency Use Authorization of Sputnik V
February 19, 2021 GMT
HYDERABAD, India (BUSINESS WIRE) Feb 19, 2021
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced that it has initiated the process with the Drugs Controller General of India (DCGI) for Emergency Use Authorization (EUA) of the well-studied human adenoviral vector-based platform vaccine candidate, Sputnik V.
As part of the review process, Dr. Reddy’s will present the safety profile of the phase 2 study, and interim data of the phase 3 study, which is expected to complete by 21 st February 2021.
Dr Reddy s Laboratories along with its subsidiaries announced the launch of Fluphenazine Hydrochloride Tablets, USP, in the U.S. market.
The company along with its subsidiaries today announced the launch of Fluphenazine Hydrochloride Tablets, USP, a therapeutic equivalent generic version of Prolixin Tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, approved by the U.S. Food and Drug Administration (USFDA).
The Prolixin brand and generic had U.S. sales of approximately $134 million MAT for the most recent twelve months ending in December 2020 according to IQVIA Health.
Dr Reddy s Fluphenazine Hydrochloride Tablets, USP are available in 1 mg, 2.5 mg, 5 mg, and 10 mg tablets in 100 bottle count sizes.
On a consolidated basis, Dr. Reddy s Laboratories posted a net profit of Rs 19.80 crore in Q3 FY21 as against a net loss of Rs 569.7 crore in Q3 FY20.The drug maker s consolidated revenue increased 12% year on year to Rs 4930 crore in Q3 FY21. Dr. Reddy s registered a profit before tax of Rs 284.3 crore in Q3 FY21 compared with pre-tax loss of Rs 527.40 crore posted in the same period last year. Tax expense surged to Rs 264.5 crore in Q3 FY21 as against Rs 42.30 crore in Q3 FY20.
The company reported impairment charge of about Rs 600 crore during the quarter. In January 2021 there has been an additional generic launch for the product Nuvaring, which has led to considerable erosion in the value of this product for the company, and accordingly the firm took an impairment charge of Rs 320 crore. In addition, considering the current market dynamics, the firm took an additional impairment charge of Rs 280 crore on the intangibles pertaining to other products. The firm had an impairment
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Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY along with its subsidiaries together referred to as “Dr. Reddy’s”) and Global Response Aid FZCO (GRA) today announced the termination of Avigan Trial Study conducted in Kuwait focused on moderate to severe COVID patients in a hospital setting.
The hospitalized patient study, conducted in Kuwait, on moderate to severe patients was one of the studies in the overall clinical program for Avigan, spanning the spectrum of Asymptomatic to severe cases of COVID in both outpatient and in-patient setting. The Phase-III study, being conducted in an outpatient setting on patients with mild to moderate symptoms in North America by Dr. Reddy’s, in partnership with Appili Therapuetics and Global Response Aid, shall continue.