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Food And Drug Administration

Feb 17, 2017 at 14:26 | Source: PTI
Drug firm Zydus Cadila has received approval from the US health regulator to market fluconazole tablets used for the treatment of fungal infections.
Feb 17, 2017 at 09:51 | Source: CNBC-TV18
Biocon Thursday announced the US Food and Drug Administration has accepted Mylans Biologics License Application (BLA) for biosimilar chemotherapy drug Pegfilgrastim for review. Sharing details on the development with CNBC-TV18 Biocon Chairperson and Managing Director Kiran Mazumdar Shaw said, "This is a very important acceptance."
Feb 16, 2017 at 15:24 | Source: PTI
"United States Food and Drug Administration (USFDA) inspected company's Moraiya facility from February 6, 2017 to February 15, 2017. At the end of the inspection no observation (483) is issued," Cadila Healthcare said in a filing to BSE.
Feb 16, 2017 at 12:51 | Source: Moneycontrol.com
Halol is an important plant for Sun Pharma and contributed 10-15 percent to its US sales before the factory received a warning letter from the US Food & Drug Administration for violation of manufacturing norms in December 2015.
Feb 14, 2017 at 15:36 | Source: CNBC-TV18
During his campaign, US president Donald Trump vowed to ease the burden of the healthcare industry in US by reducing taxes and government regulations. Two important decisions expected from the Trump administration is appointment of Food and Drug Administration (FDA) commissioner and drug price control.
Feb 03, 2017 at 16:00 | Source: Moneycontrol.com
Lupin has received final approval for its Triamcinolone Acetonide cream USP, 0.025 percent, 0.1 percent and 0.5 percent from the United States Food and Drug Administration to market a generic equivalent of Mylan Pharmaceuticals Incs Triamcinolone Acetonide cream.
Feb 02, 2017 at 16:50 | Source: PTI
Pharma firm Strides Shasun Limitedtoday announced that its subsidiary Strides Pharma Global PteLimited, Singapore has received tentative approval from theUnited States Food & Drug Administration (USFDA) for its ParaIV filing of Fingolimod capsules.
Feb 02, 2017 at 15:34 | Source: Moneycontrol.com
Strides Shasun subsidiary Strides Pharma Global Pte, Singapore has received tentative approval from the United States Food & Drug Administrative for its Para IV filing of Fingolimod Capsules, 0.5 mg.
Feb 02, 2017 at 09:43 | Source: Moneycontrol.com
The company has received the Establishment Inspection Report (EIR) from the United States Food & Drug Administration (USFDA) for its Bavla facility on February 01.
Jan 27, 2017 at 17:34 | Source: PTI
South Korean firm Mezzion Pharmahas filed a suit against Dr Reddy's Laboratories in the USalleging that the Indian company hid "significantdeficiencies" and misrepresented compliance with the Food andDrug Administration (FDA) cGMP practices.
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, by the United States Food and Drug Administration (USFDA), has been completed on February 21, 2017," Dr Reddy`s Laboratories said in a filing to BSE. The company has been issued a Form 483 with three observations, which is being addressed, it added. According to FDA, "Form 483 is issued to firm management

10.48 PM Feb 21st

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same was mentioned for last week . However, We feel that pharmaceutical shares may see some more gains as investors will once again look for bargain buys in the sector on positive news. Shares of Cadila Healthcare continued to rise and ended up 4.8% after it got approval from the US Food and Drug

12.44 PM Feb 19th

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South Korean firm Mezzion Pharma has filed a suit against Dr Reddy's Laboratories in the US alleging that the Indian company hid "significant deficiencies" and misrepresented compliance with the Food and Drug Administration (FDA) cGMP practices.

5.34 PM Jan 27th

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Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Dalfampridine Extended-Release Tablets, 10 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited s Dalfampridine Extended-Release Tablets, 10 mg to be bioequivalent and

12.55 PM Jan 26th

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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.

2.36 PM Jan 25th

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, and Waluj and Chikalthana in Maharashtra, which are under US Food and Drug Administration`s import alert. Timelines on the resolution of the regulatory issues would be a key issue to watch out for in the earnings. For time being avoid longs in Pharma stocks or consider as long term investment

5.21 PM Jan 21st

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Panacea Biotec  

in a sustainable manner in mid to long term. The Capital-based firm has received approval from the US Food and Drug Administration (USFDA) to market its generic product to treat migraine in strenghts of 5 and 10 mg, Panacea Biotec said in a statement. Panacea`s product is equivalent to Merck & Co`s Maxalt

12.27 PM Jan 19th

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the generic version of the drug upon receiving approval from the Food and Drug Administration.Mylan has further allegedly stated that it is working towards January 28, 2017 as its target date for Abbreviation New Drug Application approval.

11.08 AM Jan 19th

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Source:----BL:----) January 18, 2017: Panacea Biotec on Wednesday said the US Food and Drug Administration has approved the company s abbreviated new drug application for rizatritan benzoate orally disintegrating tablets of 5 mg and 10 mg strengths, which is the generic equivalent of Maxalt

9.26 PM Jan 18th

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Panacea Biotec announces that United States Food and Drug Administration (USFDA) has granted approval for ANDA to market a generic version of Rizatriptan Benzoate Tablets, Orally disintegrating, 5 mg and 10 mg.

12.39 PM Jan 18th

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