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Us Food And Drug Administration

Mar 24, 2017 at 21:12 | Source: CNBC-TV18
An inspection by the US Food and Drug Administration took place at the sterile injectables manufacturing unit between March 9 and 17.
Mar 23, 2017 at 15:58 | Source: PTI
The company has received final approval from the US Food and Drug Administration (USFDA) for its Tobramycin Inhalation Solution, the Mumbai-based company said in a statement.
Mar 08, 2017 at 11:54 | Source: PTI
"The company has received final approval from the US Food and Drug Administration (USFDA) to market tizanidine hydrochloride capsules, USP in strengths of 2mg, 4mg and 6mg," Zydus Cadila said in a regulatory filing today.
Mar 07, 2017 at 13:34 | Source: PTI
The company "announced today the launch of generic paxil CR extended release tablets, 12.5 mg, 25 mg and 37.5 mg, having received an approval from the United States Food and Drug Administration (FDA) earlier", Lupin said in a BSE filing.
Mar 06, 2017 at 14:08 | Source: PTI
"The United States Food and Drug Administration (USFDA) inspected our facility at village Aroor from February 27, 2017 to March 3, 2017. There is only one observation," Everest Organics said in a filing to BSE.
Mar 02, 2017 at 14:39 | Source: Moneycontrol.com
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.
Mar 01, 2017 at 12:39 | Source: Moneycontrol.com
Analysts believe that Neuland Labs is a supplier of API (active pharma ingredient) to Teva for this drug, which is used in the therapy of Huntington Disease, a disorder related to tardive dyskinesia. If the new drug application is accepted, Neuland will be a key beneficiary.
Mar 01, 2017 at 11:41 | Source: Moneycontrol.com
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.
Feb 28, 2017 at 11:48 | Source: Moneycontrol.com
Suprep follows a split dose regime and Lupin has got approval for Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, all of which are taken to cleanse the colon before colonoscopy in adults. Suprep Bowel Prep Kit has a market of $207 mn in the USA.
Feb 28, 2017 at 11:24 | Source: PTI
The approved product is indicated for cleansing of the colon in preparation of colonoscopy in adults. Suprep Bowel Prep Kit had US sales of USD 207.2 million.
Messages on Us Food And Drug Administration »

kalpataru70

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Divis Labs  

The US Food and Drug Administration (USFDA) has added one more clause in its import alert given to the drug maker, Divi`s Laboratories Limited. The USFDA is alleging the Company of refusal for inspection . Divi`s Laboratories has been reeling under pressure due to USFDA s import alert. However

1.37 PM Mar 23rd

uuuthh

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6952 Followers

NIFTY NEXT 50  

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

Wire News

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725 Followers

News Now  

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

uuuthh

Platinum Member

6952 Followers

Sun Pharma  

, 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

Chari_2014

New Member

8 Followers

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

k.v.renga

Platinum Member

1471 Followers

Panacea Biotec  

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

Wire News

Platinum Member

725 Followers

News Now  

US Food and Drug Administration (USFDA) will re-audit three manufacturing facilities of Dr Reddy's Laboratories in the current quarter.

3.34 PM Jan 12th

bseguru17

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1 Followers

Natco Pharma  

Following the approval from the US Food and Drug Administration for its generic version of Bendamustine Hydrochloride powder for injection, 25 mg/vial and 100 mg/vial (singe-dose vial), Natco Pharma will launch the drug on November 1, 2019 or earlier in the US market.

4.38 PM Jan 10th

ahaslaltirm
a

Platinum Member

898 Followers

Wockhardt  

will continue to supply of APIs across European Union that contributed about 37 percent of company`s revenue in FY16. Three days back, the same active pharmaceutical ingredient plant had received a warning letter from the US Food and Drug Administration. The USFDA had imposed import alert on the company

2.03 PM Jan 9th

Wire News

Platinum Member

725 Followers

News Now  

Natco Pharma Ltd today said following the approval from US Food and Drug Administration for its generic version of Bendamustine Hydrochloride powder for injection, 25 mg/Vial and 100 mg/Vial (Singe-Dose Vial), it will launch the drug on November 1, 2019 or earlier in USA market.

2.22 PM Jan 6th

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