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About 257 results for "us fda"

Ipca to seek US FDA re-audit of Pithampur and Ratlam facilities
Money Control

Granules India gains 10% after US FDA gives no observations to...

The company received the Establishment Inspection Report (EIR) for an inspection that was carried in October 2016. Money Control, 2 days ago

268 images for us fda

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Sun Pharma says it sought re-inspection of its Halol facility, awaiting US FDA response

Shanghvi said the drug maker is giving top priority to bring back Halol unit under compliance
 Money Control1 week ago FDA approves AbbVie's hepatitis C drug  Reuters2 weeks ago FDA rejects Eagle Pharmaceuticals' heat stroke treatment  Reuters3 weeks ago FDA Approved Drug for Hepatitis C: New Fixed-Dose Combination - Sofosbuvir, Velpatasvir and Voxilaprevir  Med India3 weeks ago
Money Control

Claris Lifesciences loses 5% as US FDA issues 18 observations at Ahmedabad plant

The site was inspected by the US drug regulatory between July 27 and August 4, 2017.
 Money Control1 week ago US FDA conducts surprise audit at Claris Life#39;s Ahmedabad unit  Money Control2 weeks ago Vista Pharma#39;s Telangana plant gets warning letter from US FDA  Money Control1 month ago Torrent Pharma's Dahej unit gets five US FDA observations  Business Standard1 month ago
Money Control

Glenmark Pharma gets USFDA approval for skin cream generic

"Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food Drug Administration (US FDA) for Desonide Cream, 0.05 per cent, the generic version of Desonide Cream, 0.05 per cent of Perrigo New York Inc," Glenmark ...
 Money Control3 weeks ago Aurobindo Pharma jumps after FDA approval for generic drug  Business Standard1 month ago HDFC Securities expects Aurobindo Pharma to touch Rs 760  Money Control1 month ago US FDA approves Glenmark Pharma's drug for overactive bladder  Business Standard1 month ago
Money Control

FDA approves leukemia treatment developed by Celgene, Agios

(Reuters) - The U.S. Food and Drug Administration (FDA) on Tuesday approved Celgene Corp and Agios Pharmaceuticals Inc's oral treatment for acute myeloid leukemia (AML) patients with a rare genetic mutation.
 Reuters2 weeks ago Indian pharma gets US FDA booster dose  Business Standard3 weeks ago Roche leukaemia drug gets FDA breakthrough therapy designation  Reuters3 weeks ago Lupin, Sun Pharma gain nearly 2% as USFDA approves Armodafinil, Paroxetine  Money Control1 month ago

Biocon slides on reports of US FDA observations

Shares of Biocon Ltd fall as much as 7.6 pct to 346.70 rupees - its biggest intraday pct loss since March 2. U.S. FDA issued 10 observations pointing at aseptic practices after an inspection at the drugmaker's plant in Bengaluru, media reports said citing a ...
 Sify2 weeks ago Indian shares fall; Reliance Industries, pharma stocks drag  Sify2 weeks ago BUZZ-India's IPCA Labs slumps; FDA bars U.S. entry of certain drugs  Sify2 months ago Nifty, Sensex fall; Reliance Industries, pharma stocks drag  Sify2 weeks ago
Money Control

Amgen gets fast FDA review for adding heart benefits to cholesterol drug label

Amgen Inc said on Thursday the U.S. Food and Drug Administration granted priority review to the company's request to add important heart safety data to the label of its expensive injectable cholesterol drug Repatha. The FDA will decide by Dec. 2 whether to ...
 Reuters3 weeks ago Biocon hits record high after US FDA approves new breast cancer drug  Business Standard1 month ago US FDA approves Biocon's biosimilar trastuzumab- a breast cancer drug  Business Standard1 month ago Biocon in focus as breast cancer biosimilar gets US FDA advisory panel’s endorsement  Money Control1 month ago
Money Control

Cadila Healthcare rises 3% on Mesalamine launch in US, FDA nod for Pitavastatin

Moneycontrol News Cadila Healthcare shares rallied 3 percent intraday Wednesday after the launch of drug that used for the treatment of mild to moderate ulcerative colitis, in the US and the FDA approval for cholesterol drug. Subsidiary Zydus Cadila has ...
 Money Control1 month ago Cadila rises 4% on Mesalamine launch in US, FDA nod for Tranexamic Pitavastatin  Money Control1 month ago Zydus Cadila gets US FDA approval to market generic Hepatitis B drug  Business Standard1 month ago Cadila Healthcare aims to double US business to $1 billion in 3 years  Business Standard1 month ago
Money Control

Lupin gains nearly 3% post US FDA nod to infection drug

Pharma major got the regulator’s nod to market a generic version of Valeant Pharma’s Ancobon capsules.
 Money Control1 month ago Cadila gains after US arm gets FDA nod to attention deficit, sleep disorder drug  Money Control1 month ago Zydus' Nesher Pharmaceuticals gets FDA nod for antifungal drug  DNA2 months ago Zydus' Nesher Pharma gets US FDA nod for antifungal drug  Business Standard2 months ago
Money Control

US FDA steps add to pricing woes of pharma firms

FDA measures are part of its Drug Competition Action Plan
 Business Standard1 month ago USFDA to lift barriers on generic drug competition to address pricing problem  Money Control1 month ago As antidote to rising drug prices, US FDA working on plan to increase generic competition  Money Control1 month ago
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