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The formulation, to be sold under the Zidavi brans for Rs 2,700 a vial, has been approved by US FDA, European Medicines Agency, and CDSCO
Enzene said it has built a highly experienced 400-person team under the leadership of Dr. Himanshu Gadgil, CEO at Enzene Biosciences Ltd
Stocks to watch today: LIC, M&M, Adani Power, Hindalco Industries will report the July-September (Q2FY23) quarter results on Friday, November 11
Alkem Laboratories on Thursday said the US health regulator has issued three observations after inspecting its St Louis-based manufacturing facility. The US Food and Drug Administration (USFDA) had conducted a pre-approval inspection at the plant from October 31, 2022 to November 9, 2022, the drug firm said in a regulatory filing. At the end of the inspection, the company received Form 483 with three observations, it added. "There is no data integrity observation. This pre-Approval Inspection is part of the routine business operations and the company shall submit to US FDA within the stipulated timeline, a detailed response to close out the said observations," the company said. As per USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Among individual stocks, Asian Paints, EIH and Alkem Laboratories can rally up to 18 per cent each. Hindustan Unilever and Metro Brands too are poised to log smart gains, indicate charts.
One injection will cost Rs 1.25 lakh with effects lasting for two years or more
Alkem Laboratories expects the Indian pharmaceutical industry to rebound to 8-11 per cent growth rate with normalcy in activities as the pandemic eases out
It was alleged that IIFL Wealth Management Ltd and IIFL Securities Ltd knowingly manipulated the reference price of Alkem Laboratories for a block deal
The pharma index had taken a breather over the past three months after displaying relative out-performance during CY20-21.
Companies may, however, report sequential drop in numbers as Q1FY22 coincided with outbreak of second Covid wave, say brokerages
The stock price of Alkem Laboratories has broken out on the daily chart
The stock price has already broken out on the daily chart to close at an all-time high with higher volumes
Higher chronic sales, US market could offset some of the weakness in sales growth
Alkem Laboratories has launched Favipiravir under the brand name 'Alfluenza' in India for the management of mild to moderate cases of Covid-19
Data from market research firm AIOCD-AWACS shows that sales of oseltamivir (common brand Tamiflu), used against the influenza virus and also for swine flu, went up by 35.8 per cent in April
The USFDA has now issued an EIR for the manufacturing facility, it added.
CCI said it has passed an order against the entities for violating provisions of the Competition Act by involving in anti-competitive business practices.
The board of directors of the company has declared an interim dividend of Rs 22 per equity share for the financial year 2019-20.
Any adverse outcome of the FDA's observations will impact the company's overall growth
The stock dipped 11% to Rs 1,858 on the BSE in intra-day trade on back of heavy volumes.