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About 288 results for "us food drug administration"

Lupin launches pain relief drug in US
Money Control

Aurobindo Pharma get USFDA approval for Meropenem Injection

Aurobindo Pharma has received final approval from the US Food Drug Administration to manufacture and market Meropenem Injection 500 mg/ vial and 1g/vial. Money Control, 10 hours ago
Glenmark gets USFDA nod for skin ointment Business Standard, 1 week ago
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1,402 images for us food drug administration

Reuters, 18 hours ago
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NBCNews.com, 1 month ago
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PharmaVOICE, 2 months ago
Reuters, 1 month ago
Money Control, 1 week ago

Aurobindo Pharma up 1% on US FDA nod to anesthesia drug

The company received the nod from US Food and Drug Administration (FDA) for Etomidate injectable or Amidate generic. Edomidate is used for induction of general anesthesia and sedation.
 Money Control3 weeks ago USFDA clears Glenmark's investigational new drug application  Business Standard2 weeks ago BUZZ-India's Dishman Pharmaceuticals hits all-time high on FDA nod for cancer drug  Sify10 hours ago FDA nod for anti-migraine drug to lift US revenues: Panacea  Money Control2 months ago
Reuters

FDA approves Tesaro's ovarian cancer drug

The U.S. Food and Drug Administration on Monday approved Tesaro Inc's drug, niraparib, for the treatment of recurrent ovarian cancer. Epithelial ovarian, fallopian tube or primary peritoneal cancer affects the tissue covering the ovary or lining of the ...
 Reuters18 hours ago Merck's Keytruda wins FDA nod for treating blood cancer  Reuters1 week ago FDA approves Lexicon Pharma's carcinoid syndrome diarrhea drug  Reuters3 weeks ago FDA to expedite review of Teva drug for movement disorder  Reuters4 weeks ago
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Money Control

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 Control4 days ago Glenmark rises 4% on receipt of inspection report from US FDA  Money Control1 week ago FDA warns Pfizer over contaminated drugs at Kansas plant  Reuters3 weeks 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 Standard6 days ago Divi’s Labs plunges 17% on US FDA import alert on Vizag unit  Money Control1 week ago
Money Control

USFDA issues warning letter to USV Pvt over Daman plant

In a warning letter, the US Food and Drug Administration (USFDA) said the firm failed to establish laboratory controls designed to make sure components, drug product containers, closures, in-process materials, labeling, and drug products conform to ...
 Money Control5 days ago Badrivishal Chemicals gets USFDA warning for Pune plant  Business Standard1 week ago Wockhardt Shendra plant yet to get Irish regulator's nod  Business Standard2 weeks ago USFDA issues warning letter to Megafine Pharma for Vapi plant  Money Control2 weeks ago
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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 Standard2 weeks ago Sun Pharma's Mohali plant out of US FDA's Import Alert list  Prokerala2 weeks ago Sun Pharma soars 6% on US FDA’s plan to lift import alert at Mohali  Money Control2 weeks ago Sun Pharma up 3% as co may shift key products from Halol plant  Money Control1 month ago

Cadila Healthcare falls 7% on US FDA observations at Baddi plant

The US Food and Drug Administration (FDA) gave three observations under Form 483 for its formulations manufacturing facility at Baddi. These were related to pre-approval inspections for a specific product filed.
 Money Control3 weeks ago Alembic Pharma shares rise over 3 %; mcap rises by Rs 403 cr  Business Standard2 weeks ago US FDA observations on Natco Pharma's Hyderabad facility  Business Line2 months ago Alembic Pharma's Baroda facility completes USFDA inspection  Business Standard2 weeks ago

BUZZ-India's Dr. Reddy's Labs hits 2-1/2-yr low on U.S. FDA observations

** Shares of Dr. Reddy's Laboratories Ltd fall asmuch as 4.21 pct to their lowest since Aug 13, 2014 ** U.S. Food and Drug Administration (U.S. FDA) completesaudit of drugmaker's formulation manufacturing unit near thecity of Vishakapatnam in the southern ...
 Sify2 weeks ago Dr Reddy's fails one more US FDA test  Business Standard2 weeks ago Dr. Reddy's Labs hits 2-1/2-year low on US FDA observations  Sify2 weeks ago
DNA

Biocon chief sees anti-cancer biosimilar launch in FY19

Biocon Thursday announced the US Food and Drug Administration has accepted Mylan’s Biologics License Application (BLA) for biosimilar chemotherapy drug Pegfilgrastim for review. Sharing details on the development with CNBC-TV18 Biocon Chairperson and ...
 Money Control1 month ago Biocon scales record high as USFDA accepts BLA for proposed biosimilar Trastuzumab  Business Standard2 months ago US nod for Biocon-Mylan biosimilar  Business Line2 months ago Biocon up 3% as USFDA accepts Trastuzumab license application  DNA2 months ago
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