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About 238 results for "us food and drugs administration"

Sun Pharma asks for withdrawal of 28 drug applications

Panacea Biotec Limited

on Wednesday said the US Food and Drug Administration has approved the companys abbreviated new drug application for rizatritan benzoate orally disintegrating tablets of 5 mg and 10 mg strengths, which is the generic equivalent of Maxalt-MLT marketed by Merck ... Business Line, 1 month ago
Ajanta Pharma: USFDA nod adds strength Business Line, 1 month ago

1,397 images for us food and drugs administration

Reuters, 6 days ago, 2 weeks ago, 4 weeks ago, 2 weeks ago, 2 weeks ago
Reuters, 2 weeks ago
PharmaVOICE, 1 month ago
CNN, 2 weeks ago
Yahoo! News, 1 month ago
PharmaVOICE, 2 months ago
Money Control

USFDA bans drugs import from Badrivishal Chemicals' Pune plant

The US Food and Drug Administration (USFDA) has issued the alert under 'Import Alert 66-40', which authorises the health regulator "detention without physical examination of drugs from firms which have not met drug GMPs".
 Money Control1 month ago

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 Control5 days ago US nod for Biocon-Mylan biosimilar  Business Line1 month ago Biocon scales record high as USFDA accepts BLA for proposed biosimilar Trastuzumab  Business Standard1 month ago Biocon up 3% as USFDA accepts Trastuzumab license application  DNA1 month ago
Money Control

USFDA raises issues over Natco Pharma’s formulations plant

The US Food and Drug Administration (USFDA) has raised some issues after inspection of its Kothur formulations facility. The inspection was conducted in the Kothur plant near here during January 16-24, 2017. At the end of the inspection, the facility received ...
 Business Line4 weeks ago Hikal gallops as USFDA issues zero observations after inspection of Jigani plant  Business Standard1 month ago Wockhardt shares recover; ends marginally down  India Infoline1 month ago USFDA issues warning letter to Wockhardt's Ankleshwar plant  Money Control1 month ago
Money Control

Plants of Pharma major, Dr. Reddy's to be re-audited by USFDA

US Food and Drug Administration (USFDA) will re-audit three manufacturing plants of Dr. Reddy's Laboratories. After finding several violations with regard to current goods manufacturing practices (CGMPs), US Food and Drug Administration (USFDA) had sent them ...
 India Infoline1 month ago USFDA to re-audit three Dr Reddy's plants  Money Control1 month ago USFDA to re-audit Dr Reddy's 3 plants  Business Standard1 month ago
Money Control

FDA nod for anti-migraine drug to lift US revenues: Panacea

The company Wednesday received the US Food and Drug Administration (USFDA) approval for an anti-migraine drug for which it had filed the Abbreviated New Drug Application (ANDA) in 2012.
 Money Control1 month ago Alembic receives USFDA approval for Itraconazole capsules  Business Standard2 months ago Dr.Reddy’s launches anti-fungal cream in the U.S.  The Hindu2 months ago Alembic Pharmaceuticals Ltd drops 1.23%  India Infoline2 months ago
Money Today

Natco Pharma did not follow quality control measures: USFDA

The US Food and Drug Administration (FDA) has noted that city-based Natco Pharma did not follow quality control measures "fully" at its formulation plant in Telangana. The US drug regulator has made six observations after the completion of inspection of its ...
 Business Standard3 weeks ago U.S. FDA finds quality control problems at Sun Pharma's Halol plant  Business Standard2 months ago Sun Pharma stock closes 5.96% lower as US finds more concerns at Halol plant  Money Today2 months ago Sun Pharma up 3% as co may shift key products from Halol plant  Money Control5 days ago

US FDA observations on Natco Pharma's Hyderabad facility

on Wednesday said it has been handed six observations by the US Food and Drug Administration for its facility at Kothur, near Hyderabad. The observations follow an inspection of the facility between January 16 and 24, the company said. The observations were ...
 Business Line3 weeks ago Glenmark Pharma's Ankleshwar plant gets 4 FDA observations  Business Standard18 hours ago USFDA makes 6 observations at Natco Pharma's Kothur facility  Business Standard4 weeks ago Alkem Labs gets EIR from USFDA for Daman facility  Business Standard2 months ago

Indian American could be FDA head under Trump

Indian-American biotech entrepreneur Balaji Srinivasan is being considered for a role in the U.S. Food and Drug Administration (FDA) under President Donald Trump, the transition team said.Mr. Sriniva...
 The Hindu1 month ago Indian American on Trump probables list for USFDA chief  Business Line1 month ago
Money Today

Divi’s Labs: FDA notice may impact stock

Divis Laboratories on Wednesday said its Visakhapatnam unit-II received a Form 483 letter from the US Food and Drug Administration. Form 483 is issued to a firms management at the conclusion of an inspection where investigators observe any conditions, which ...
 Business Line2 months ago Vivimed Labs closes 8% higher post USFDA inspection at Alathur facility  Money Today2 months ago Vivimed Labs Alathur unit completes successful USFDA visit  Money Control2 months ago
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