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Us Drug Regulator

Feb 27, 2017 at 13:58 | Source: PTI
The company has received approval from the US Food and Drug Administration (USFDA) for Itraconazole capsules, a generic version of Janssen Pharmaceuticals' Sporanox, Jubilant Life Sciences said in a regulatory filing.
Feb 27, 2017 at 12:46 | Source: PTI
"Nesher Pharmaceuticals, a subsidiary of Zydus Pharmaceuticals USA has received the final approval from the United States Food and Drug Administration (USFDA) to market oseltamivir phosphate capsules in strengths of 30 mg, 45 mg, and 75 mg," Cadila Healthcare said in a BSE filing.
Feb 27, 2017 at 11:52 | Source: Moneycontrol.com
Cadilas subsidiary, Zydus Cadila, received regulatory approvals to launch tetravalent inactivated influenza vaccine for seasonal flu in India. Meanwhile, Zydus received the approval from US Food and Drug Administration (FDA) for Linezolid tablets. These are used to treat skin infections and pneumonia.
Feb 27, 2017 at 10:45 | Source: Reuters
Chinese authorities have taken a raft of steps in recent months to curb capital flight from the country to support the weakening yuan currency, while trying to attract more foreign investment.
Feb 25, 2017 at 17:02 | Source: PTI
No action will be taken against hospitals under the scanner for overcharging on stents if they refund the money to patients before receiving a demand notice, drug price regulator NPPA said.
Feb 25, 2017 at 14:30 | Source: PTI
US President Donald Trump has signed an executive order directing his administration to set up a task force to remove "job-killing regulations" in an effort to make the country a business-friendly destination.
Feb 25, 2017 at 09:34 | Source: Reuters
Citigroup Inc on Friday said that U.S. government and regulatory agencies are investigating the bank's hiring practices.
Feb 25, 2017 at 09:33 | Source: Reuters
Pfizer Inc on Thursday said it received subpoenas from the U.S. Attorney's Office for the District of Massachusetts related to the drugmaker's support for organizations that provide financial help to Medicare patients.
Feb 25, 2017 at 09:04 | Source: PTI
US President Donald Trump todaysigned an executive order directing various wings of hisadministration to establish a regulatory reform task force ina bid to remove "job-killing regulations" and "unleasheconomic opportunity".
Feb 24, 2017 at 21:20 | Source: Moneycontrol.com
Faced with increasing regulatory scrutiny -- Indian drug makers working more closely then ever before on Friday said they have been investing on automation, simplifying and standardizing systems and working on building culture of compliance within their organizations -- as they dont want to be seen as outliers in terms of regulatory compliance.
Messages on Us Drug Regulator »

mickeychike
y

New Member

16 Followers

Sun Pharma  

of manufacturing norms in December 2015. The warning letter was after the facility first inspected by the US drug regulator in September 2014 and since then no products have been approved from the plant by the US FDA.

3.28 PM Feb 16th

bapu_1964

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1 Followers

Divis Labs  

Divis has filed a detailed response to the Form 483 observations of the US FDA on corrective measures to be implemented after the company s Vizag facility got adverse observations from US drug regulator ! Is it accepted by the Authority ?

4.50 PM Jan 25th

BSE/NSE Announcer

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Wockhardt  

With reference to news appeared in Business Standard dated January 04, 2017 quoting "US drug regulator issues warning to Wockhardts Ankleshwar plant", Wockhardt Ltd has submitted to BSE a copy of Clarification is enclosed.

1.18 PM Jan 4th

BSE/NSE Announcer

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21441 Followers

Wockhardt  

The Exchange has sought clarification from Wockhardt Limited with respect to recent news item captioned "US drug regulator issues warning to Wockhardts Ankleshwar plant.". In this regard, Exchange have advised the Company to provide clarification/confirmation on the news item in detail including

11.11 AM Jan 4th

BSE/NSE Announcer

Platinum Member

21441 Followers

Wockhardt  

The Exchange has sought clarification from Wockhardt Ltd on January 04, 2017 with reference to news appeared in Business Standard dated January 04, 2017 quoting "US drug regulator issues warning to Wockhardts Ankleshwar plant".The reply is awaited.

10.29 AM Jan 4th

kalpataru70

Platinum Member

523 Followers

Aurobindo Pharm  

the development, a company official said they had received a minor observation from the US drug regulator in the month of October and it was not going to have any material impact going forward. Earlier in February, Aurobindo`s Unit VII in Mahaboobnagar district in Telangana received some Form 483 observations

10.21 PM Dec 21st 2016

porfavor

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3 Followers

Sun Pharma  

drug used to treat dry eye disease. The drug is currently undergoing late stage clinical trials (phase III) and about 16 million people in the US itself are believed to have been suffering from dry eye disease.Currently there are two drugs approved by the US drug regulator for this condition. Allergan

1.12 PM Dec 1st 2016

sanvad2016

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Sun Pharma  

Sun Pharma: The US drug regulator has found seven breaches of manufacturing standards at Sun Pharmaceutical Industries Ltd’s formulations plant in Mohali, Punjab, following a recent inspection.

10.07 AM Nov 25th 2016

premiumstoc
ktips

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99 Followers

Alkem Lab  

alkem laboratories has dipped 8% to rs 1,655 on the bse in early morning trade after the pharmaceuticals company said it has received 13 observations from the us drug regulator for its manufacturing facility at daman;

11.09 AM Sep 30th 2016

premiumstoc
ktips

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Marksans Pharma  

Marksans Pharma moved higher by 11% on the BSE after the company announced that it has got US drug regulator nod for loratadine liquid filed capsules 10 mg.

5.11 PM Sep 26th 2016

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