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About 257 results for "us fda"

Zydus receives US FDA approval for anti-viral drug oseltamivir
Business Standard

Lupin receives US FDA approval for tobramycin inhalation solution

The product is Lupin's first generic approval in the inhalation space March 24, 2017 Last Updated at 17:22 IST Lupin Limited has received final approval for its tobramycin inhalation solution (300 mg/5 ml) from the US Food and Drug Administration (FDA). The ... Business Standard, 11 hours ago

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Business Standard, 1 month ago
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Pfizer#39;s Hospira receives 11 FDA observations for Vizag unit

An inspection by the US Food and Drug Administration took place at the sterile injectables manufacturing unit between March 9 and 17.
 Money Control8 hours ago FDA warns Pfizer over contaminated drugs at Kansas plant  Reuters3 weeks ago

Divis Laboratories: Updates on USFDA alert

The company has already initiated necessary measures to address the concerns raised by the US-FDA and is making all efforts to fully meet the compliance requirements.
 Money Control1 day ago Divis Lab: Update on USFDA inspection of Unit-II at Visakhapatnam  Money Control2 months ago

USFDA adds one more clause to import alert on Divi's Labs

BS ReporterHyderabad, 22 March: The US Food and Drug Administration(US FDA) has invoked one more clause with regard to the import alert issued to Unit-2 of Hyderabad-based Divis Laboratories Limited, this time charging the company with 'refusal for ...
 Business Standard2 days ago Divi's Labs barred from exports to US after FDA import alert on Vizag unit  Business Standard3 days ago Divi’s Labs plunges 17% on US FDA import alert on Vizag unit  Money Control3 days ago

Divis Laboratories receives import alert 66-40 from USFDA

We wish to state that US-FDA has issued an Import Alert 66-40 on 20th March 2017 on the products manufactured at the company's Unit-II at Visakhapatnam, Andhra Pradesh.
 Money Control3 days ago Mfg norms, inspection issues led to USFDA alert on Divis Labs  Business Standard2 days ago
Money Control

Here’s what analysts feel about Dr Reddy’s Labs post US FDA observations

Typically, the US drug regulator conveys its concerns on manufacturing practices through Form 483. Companies that receive its observations must respond in writing with a corrective action plan and implement it quickly
 Money Control2 days ago Dr Reddy's gets 13 observations from USFDA for Duwada facility  Money Control2 weeks ago How Dr Reddy's plans to win the US market  Rediff.com1 week ago USFDA concludes inspection of Dr Reddy's Miryalaguda facility  Money Today1 month ago

FDA Woes: Pharma Companies feel the US FDA heat

The US drug regulator off late, has been a cause of headaches for many domestic pharmaceutical companies. Today, shares of Divis Laboratories tanked 20 percent after an import alert was issued its on Vizag unit. The Dr Reddy#39;s Laboratories shares also hit ...
 Money Control3 days ago Alembic Pharma shares rise over 3 %; mcap rises by Rs 403 cr  Business Standard2 weeks ago Alembic Pharma's Baroda facility completes USFDA inspection  Business Standard2 weeks ago

US FDA ban on Sun Pharma unit lifted after over 3 years

The US Food and Drug Administration (FDA) said it would remove the nearly three-year old import sanction on Sun Pharma's Mohali plant which would allow the company to resume exports from the plant. India's largest drug maker informed the exchanges about the ...
 Business Standard1 week ago Sun Pharma's Mohali plant out of US FDA's Import Alert list  Prokerala1 week ago US FDA lifts import alert imposed on Sun Pharma's Mohali facility  Business Standard1 week ago Alkem's Baddi manufacturing facility receives 3 observations from US FDA  Business Standard1 week ago
Money Control

Biocon, Alkem Labs surge on US FDA nods to products

Biocon surged after Mylan got a nod for breast cancer tablets, while Alkem Labs rose due to a nod for an ointment to treat ventricular tachycardia.
 Money Control1 week ago Biocon at new high; FDA accepts BLA for biosimilar Pegfilgrastim  Money Control1 month ago US FDA accepts application of Mylan & Biocon for biosimilar pegfilgrastim  Business Standard1 month ago FDA accepts Mylan's BLA for proposed biosimilar Pegfilgrastim  DNA1 month ago
Money Control

Glenmark rises 4% on receipt of inspection report from US FDA

The drug firm received establishment inspection report (EIR) from the US Food and Drug Administration on closure of inspection of its Ankleshwar plant in Gujarat.
 Money Control1 week ago Dishman Pharmaceuticals and Chemicals provides updates on USFDA inspection  India Infoline1 month ago Dishman Pharma receives EIR from USFDA for Bavla facility  Money Control1 month ago Dishman Pharma receives EIR report from USFDA  Business Standard1 month ago
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