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Us Drug Regulator

Mar 29, 2017 at 13:48 | Source: PTI
The company had earlier received approval from the United States Food and Drug Administration (USFDA) for Abacavir and Lamivudine tablets 600 mg/300 mg, Lupin said in a statement.
Mar 28, 2017 at 14:54 | Source: PTI
National Pharmaceutical Pricing Authority (NPPA), after analysis of market data and associated reports of December 2016 submitted by AIOCD-AWACS, has identified 634 cases where non-compliance of notified ceiling price is suspected, Minister of State for Chemicals and Fertilisers, Mansukh L Mandaviya, said in a written reply to the Lok Sabha.
Mar 28, 2017 at 14:49 | Source: CNBC-TV18
We are hopeful that the approval will come through. Let us see how much time it takes. We are hoping the next 30 days we should have an answer either way, Amitabh Chaudhry of HDFC Life.
Mar 28, 2017 at 12:02 | Source: PTI
The company "has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Meropenem injection 500 mg/vial and 1g/ vial," Aurobindo Pharma said in a filing to BSE.
Mar 28, 2017 at 10:47 | Source: Moneycontrol.com
Aurobindo Pharma has received final approval from the US Food & Drug Administration to manufacture and market Meropenem Injection 500 mg/ vial and 1g/vial.
Mar 27, 2017 at 12:40 | Source: Moneycontrol.com
Company to seek exemption of more products
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 24, 2017 at 15:50 | Source: CNBC-TV18
Dr. Reddys said it spent about $35-40 million on remediation work that includes legal and professional charges.
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 13:29 | Source: Moneycontrol.com
Drug maker Dr Reddys Laboratories will be put to a crucial test in the second week of April as the company gears up for major USFDA audits at its facilities in Srikakulam located some 70 kms away from port city of Visakhapatnam.
Messages on Us Drug Regulator »

Dr Reddys Labs  

Published in Money Control dated "Mar 24, 2017 05:17 PM IST | Source: CNBC-TV18 US regulator set to begin inspection of Dr Reddy`s Srikakulam unit on March 27 Dr. Reddy%u2019s said it spent about $35-40 million on remediation work that includes legal and professional charges. The US drug

about 1 hr 15 min 1 sec ago

nicknamecha
nged98710

New Member

26 Followers

index  

a clean chit from the US drug regulator inspection. The company didn%u2019t specify the nature of these observations. The oncology formulation facility called Unit-7 is located in Visakhapatnam Special Economic Zone (VSEZ) at Duvvada. The site manufactures cytotoxic and hormonal injectables

9.15 PM Mar 8th

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

New Member

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

Platinum Member

22036 Followers

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

Platinum Member

22036 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

22036 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

545 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

New Member

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

New Member

0 Follower

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

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