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Food And Drug Administration

Mar 27, 2017 at 13:05 | Source: Reuters
Tagrisso is designed to help cancer patients with certain genetic mutations that are very common in China and the regulatory green light boosts the British drugmaker's prospects in a key therapy area.
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 13:17 | Source: Moneycontrol.com
Unichem Laboratories has received ANDA approval from the United States Food and Drug Administration (USFDA) for Rizatriptan Benzoate ODT 5mg & 10mg and Rizatriptan Benzoate Tablets USP, 5mg & 10mg which are therapeutically equivalent to Maxalt MLT Tablets 5mg & 10mg and Maxalt Tablets 5mg 10mg of Merck & Company, Inc.
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.
Messages on Food And Drug Administration »

cindrella20
04

Platinum Member

1968 Followers

Torrent Pharma  

their hiccups in a 5-10 years cycle, they will have one such large hiccups but as you saw in the Food and Drug Administration (FDA) notification, their market share is so large that in spite of all the issues 8 products in which they are market leaders FDA had to exempt them. That tells you the story

5.09 PM Mar 25th

kalpataru70

Platinum Member

542 Followers

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

koppik

Gold Member

11 Followers

Biocon  

proposed biosimilar trastuzumab with the U.S. Food and Drug Administration (FDA), Mylan anticipates potentially being the first company to launch a biosimilar to Herceptin in the U.S." "Mylan`s proposed biosimilar trastuzumab is one of the six biologic products co-developed by Mylan and Biocon

9.06 PM Mar 13th

biomagic

New Member

19 Followers

Alkem Lab  

any of the following side-effects, especially if they do not go away. Restlessness Headache Sore Throat Blurred Vision Hives Feeling Of Discomfort If you notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug

2.22 PM Mar 8th

BSE/NSE Announcer

Platinum Member

21983 Followers

Wockhardt  

This is to inform the Exchanges that U.S. Food and Drug Administration (USFDA) has issued a Warning Letter to Morton Grove Pharmaceuticals Inc., USA, a stepdown Subsidiary of the Company. This would mean that current portfolio of the Company will continue to be made available in the market

5.36 PM Mar 1st

nicknamecha
nged98710

New Member

23 Followers

index  

, 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

uuuthh

Platinum Member

6954 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

Platinum Member

725 Followers

News Now  

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

kalpataru70

Platinum Member

542 Followers

Aurobindo Pharm  

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

Wire News

Platinum Member

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

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