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US Food and Drug Administration News
US Food and Drug Administration
N95 face masks decontamination tech to enable reuse gets US FDA nod
Mon, Mar 30, 2020
"Each Battelle CCDS Critical Care Decontamination System is capable of decontaminating up to 80,000 masks per day at full capacity. Because it is scalable, the system is capable of processing even more pieces of personal protective equipment (PPE) each day," Battelle said in a statement.
Aurobindo Pharma plant inspection: FDA team finds 'female mosquito' in its facility
Sun, Mar 11, 2018
Aurobindo Pharma facility inspection: The US FDA had issued nine observations after inspection of the drug maker's Unit 4 formulation facility near Hyderabad last month
Natco Pharma shares jump 20% as partner Mylan's injections get USFDA approval
Wed, Oct 04, 2017
With this blockbuster performance, the company's stock has reached nearly two-months high. The last time, Natco's share travelled over Rs 900-mark was on August 08, 2017.
Sun Pharma says sales may fall in 2018 as US market gets tougher for generic drugs
Sat, May 27, 2017
Sun Pharmaceutical Industries MD Dilip Shanghvi has said on Friday that the US sales might fall in 2018 because of pressure on drug prices, signalling tough market conditions in the United States (US) for generic drugmakers.
Sun Pharma shares rise as USFDA clears Mohali facility
Tue, Mar 14, 2017
Sun Pharma said, “It's subsidiaries or associate was informed by the US FDA yesterday, that it will lift the import alert imposed on the Mohali (Punjab) manufacturing facility and remove the facility from the official action initiated (OAI) status."
Wockhardt shares tank over 5% after US drug regulator warning
Thu, Mar 02, 2017
In a BSE filing on Wednesday, Wockhardt said, "The US Food and Drugs Administration (USFDA) has issued a warning letter to Morton Grove Pharmaceuticals, USA, a stepdown subsidiary of the company."
USFDA to re-audit Dr Reddy's three plants in first quarter of 2017
Thu, Jan 12, 2017
US Food and Drug Administration (USFDA) will re-audit three manufacturing facilities of Dr Reddy's Laboratories in the current quarter.