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US Food and Drug Administration

Dr Reddy's recalls over 3.3 lakh bottles of generic medication in US: USFDA

Dr Reddy's recalls over 3.3 lakh bottles of generic medication in US: USFDA

Sun, Nov 03, 2024

Dr Reddy's Laboratories is recalling over 3.3 lakh bottles of a medication used to treat high calcium levels in the blood and hyperparathyroidism in the US market due to manufacturing issues.

N95 face masks decontamination tech to enable reuse gets US FDA nod

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

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

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Natco Pharma shares jump 20% as partner Mylan's injections get USFDA approval

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

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

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

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.

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