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About 122 results for "us fda"

Strides Shasun gets US FDA approval for HIV treatment drug Efavirenz
Business Standard

Strides Shasun gets US FDA approval for HIV treatment drug Efa...

Efavirenz tablet is the generic version of Sustiva tablets of Bristol-Myers Squibb Company Last Updated at March 14, 2018 17:27 IST Strides Shasun on Wedneesday said it has received approval from the US health regulator for its generic Efavirenz tablet used ... Business Standard, 4 days ago
Strides Shasun gains after FDA nod for generic drug Business Standard, 4 days ago

58 images for us fda

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Business Standard

Dr Reddy's gets 5 observations from US FDA for API unit at Hyderabad

The company said plant-3 at Bollaram on the city outskirts has recieved these observations upon completion of an inspection Last Updated at March 9, 2018 17:02 IST
 Business Standard1 week ago Dr Reddy#39;s expects US FDA re-audit of Duvvada plant in next 3-6 months  Money Control1 month ago Dr Reddy's gets 5 observations for its API plant at Medak  Business Standard1 week ago
Business Standard

US FDA finds 'female mosquito' in Aurobindo Pharma's unit during inspection

FDA also observed that Aurobindo Pharma employees lack the training required to perform their assigned functions Press Trust of India | Hyderabad Last Updated at March 11, 2018 18:53 IST US Food and Drug Administration officials found a 'large female ...
 Business Standard1 week ago Aurobindo Pharma's unit gets 9 USFDA observations  Business Standard1 week ago US inspectors cite serious quality issues at Aurobindo Pharma's Unit 4  Business Standard2 weeks ago
Money Control

Panacea Biotec clears US FDA inspection for Baddi formulation facility

The company#39;s Baddi facility manufactures anti-cancer injectables and oral solid dosage formulations.
 Money Control1 week ago
Money Control

Credit Suisse expects US FDA nod for Sun Pharma Halol unit in 4-6 months as stock trades lower

The firm expects the company to get clearance for the Halol plant in the next 4-6 months adding that the US FDA observations are not very serious. It is of the view that observations 2 and 3 are procedural in nature while observation 1 relates to aseptic ...
 Money Control1 week ago
Money Control

Sun Pharma falls 3% post Halol observations; Nomura remains neutral

The US FDA conducted Good Manufacturing Practices (GMP) inspection of Sun Pharma#39;s Halol facility from February 12 - 23.
 Money Control2 weeks ago Sun Pharma Halol facility gets three observations by US FDA  Business Standard3 weeks ago
Money Control

Cadila Healthcare plans to file biosimilar Neulasta in US by 2019 end

If everything goes well, the company expects a possible approval from the US FDA a year after filing.
 Money Control2 weeks ago
Money Control

Root cause analysis and lab controls prove to be new compliance headaches for Indian drug makers

Among import alerts or import bans issued by US FDA for more serious compliance issues, Indian sites constituted 30 percent, while China#39;s share was 50 percent in 2017.
 Money Control3 weeks ago
Business Standard

Warning letters to Indian pharma companies from US FDA declining: Study

The number of cases of data integrity violations too is showing a decline, says study by IPA and consultancy firm McKinsey Aneesh Phadnis | Mumbai Last Updated at February 22, 2018 00:02 IST Investment in automation, staff training and collaboration with ...
 Business Standard3 weeks ago
Money Control

Sun Pharma recalls over 17.5 K bottles of nasal spray from US

As per the enforcement report for week of February 21, 2017 of the US FDA, Sun Pharmaceutical Industries Inc is recalling 17,554 bottles of Azelastine HCl Nasal Solution (Nasal Spray) 0.1 per cent (137 mcg per spray), 30 ml.
 Money Control3 weeks ago Sun Pharma recalls two batches of diabetic drug from US market  Business Standard2 months ago
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