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Fda

Sep 01, 2014 at 12:03 | Source: Moneycontrol.com
Wockhardt's New Drug Discovery Programme in Anti-Infective research received a major boost after two of its drugs, WCK 771 and WCK 2349, received the coveted Qualified Infectious Disease Product (QIDP) status from the US FDA.
Sep 01, 2014 at 11:06 | Source: CNBC-TV18
"Marketing partner in the USA, Mylan Inc has filed an abbreviated new drug application (ANDA) for a three-times-a-week generic Copaxone (glatiramer acetate injection, 40 mg/ml) and has been accepted by the US Food and Drug Administration (US FDA)," said the company in its filing.
Aug 21, 2014 at 15:35 | Source: CNBC-TV18
Arvind Bothra picks Aurobindo Pharma as his favourite bet among midcaps and Sun Pharma and Lupin among large caps.
Aug 16, 2014 at 15:38 | Source: PTI
The recalled drug bottles were distributed by Caraco Pharmaceutical Laboratories, Ltd in the US while manufactured in India by Sun Pharmaceutical Industries Ltd.
Aug 13, 2014 at 19:04 | Source: Moneycontrol.com
CRISIL Ratings has come out with its report on pharma. "Drug makers capex to surge 40% on sharper global focus, but despite the increase, credit quality is expected to remain stable", says the report.
Aug 13, 2014 at 13:08 | Source: Moneycontrol.com
Citi recommends to sell it, though it sees a potential for a strong bounce back once the issues are resolved.
Aug 12, 2014 at 13:01 | Source: Reuters
The United States is Wockhardt's biggest market and the FDA has banned the import of generic drugs from two of the company's plants in India, citing quality lapses in the manufacturing process.
Aug 08, 2014 at 10:02 | Source: Moneycontrol.com
The form details two severe data integrity issues in plant observed in the inspection done between July 14 and July 18 of the Ratlam API facility. Observations also point senior staff involvement in data falsification. Lab analyst sais they were "forced" to falsify the record by a direct supervisor.
Jul 31, 2014 at 13:28 | Source: Reuters
The FDA has not expressed concerns over the entire facility, said the sources. The US agency communicated its concern to Cadila in a Form 483, a letter in which the agency typically outlines violations of standard manufacturing practices.
Jul 24, 2014 at 12:57 | Source: Moneycontrol.com
After inspecting the companys active pharmaceutical ingredients (APIs) manufacturing unit at Raltam, US Food and Drug Administration (US FDA) has raised some concerns in Form 483. Hence the drug manufacturer will suspend shipments to the US markets till the issue is addressed.
Messages on Fda »

BSE/NSE Announcer

Platinum Member

4027 Followers

Glenmark  

Glenmark Generics Inc., USA a subsidiary of Glenmark Generics has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (US FDA) for Telmisartan Tablets. Glenmark will commence distribution of the product immediately.

12.04 PM Jul 8th

BSE/NSE Announcer

Platinum Member

4027 Followers

Glenmark  

the United States Food and Drug Administration (US FDA) for Telmisartan Tablets. Glenmark will commence distribution of the product immediately.

12.04 PM Jul 8th

BSE/NSE Announcer

Platinum Member

4027 Followers

Shasun Pharma  

Shasun Pharmaceuticals Limited has informed the Exchange regarding a press release dated July 08, 2014, titled "Sucessful completion of US FDA and Mexican COFEPRIS inspection".

11.41 AM Jul 8th

BSE/NSE Announcer

Platinum Member

4027 Followers

Shasun Pharma  

Shasun Pharmaceuticals Ltd has informed BSE regarding a Press Release dated July 08, 2014, titled "Successful completion of US FDA and Mexican COFEPRIS inspection"

11.30 AM Jul 8th

hemal85

Silver Member

12 Followers

ITC  

how FDA (food & drug authority) is related with Mr. Modi?? & if u mean FDI....how will that make any difference to HUL or ITC??? kuchh bhi....

6.55 PM Jul 7th

teeyen

Silver Member

2 Followers

Natco Pharma  

Natco is an excellent stock with good prospects. However think of following before buying now. 1)Teva has filed a citizen petition before FDA which may delay copaxone generic approval by about 5-6 months 2) Teva has filed a petition in delhi high court for stopping production and export

6.38 PM Jul 7th

AlphaView

Gold Member

88 Followers

Granules India  

talking this even after discounting for risks such as FDA approvals et al.

6.13 PM Jul 7th

niftynewbie

Platinum Member

136 Followers

Ranbaxy Labs  

Spoiler could be sunpharma`s plants getting red-flagged by FDA ;)

5.10 PM Jul 7th

Sharon Bio Medicine  

Profit to fo up 3 fold! US FDA approval to come next qrtr!

3.22 PM Jul 7th

shivamparik
h

Platinum Member

38 Followers

ITC  

HUL doesnt deal in Cigarettes and FDA will be welcome by Mr. Modi. ITC may get benefits of Tourism ... HUL still wins out with a higher chance of UL bidding for complete or more control through buy out of shares. ITC will have issues with Govt. regulations in my opinion.

1.18 PM Jul 7th

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Aug 31, 2014 at 20:00 | Source: NDTV Profit
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