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Aug 27, 2016 at 18:30 | Source: PTI
Drug firm Claris Lifesciences has received approval from the US health regulator for generic Flumazenil injection used for reversal of the sedative effects of benzodiazepines in the America market.
Aug 26, 2016 at 15:58 | Source: Reuters
This is one of a series of quality concerns tied to the Philadelphia, Pennsylvania factory that the FDA highlighted in an Aug. 15 "warning letter" issued to the site's current owner, US firm Frontida BioPharm Inc.
Aug 26, 2016 at 13:10 | Source: Moneycontrol.com
Lupin has received tentative approval for its Paroxetine Extended-Release Tablets USP, 12.5 mg, 25 mg and 37.5 mg from the United States Food and Drug Administration (FDA) to market a generic version of Apotex Technologies, Inc.s Paxil CR Tablets, 12.5 mg, 25 mg and 37.5 mg.
Aug 25, 2016 at 10:14 | Source: Moneycontrol.com
The company has received a successful establishment inspection report (EIR) from the US food and drug administration (FDA) for its chemical division, Chennai, India.
Aug 25, 2016 at 09:55 | Source: Moneycontrol.com
Natco Pharma is pleased to announce receipt of successful Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for the inspection conducted, during the period February 8 - February 12, 2016, at its chemical division, Chennai, India.
Aug 25, 2016 at 08:46 | Source: PTI
Failure to correct these deviations may also result in FDA refusing admission of articles manufactured at Vapi and Bavla facilities into the United States, it added.
Aug 23, 2016 at 13:11 | Source: CNBC-TV18
The healthcare sector is facing many US Food and Drug Administration (FDA) hurdles. This is only a temporary turmoil, he says. The big Pharma names from India have huge opportunities in the US as the demand for generic drugs from India steadily rises.
Aug 17, 2016 at 17:32 | Source: PTI
Drug firm Lupin today said itssubsidiary Gavis Pharmaceuticals has received final approvalfrom the US health regulator to market potassium chlorideextended release capsules, used for treating potassiumdeficiency in the bloodstream, in the American market.
Aug 17, 2016 at 15:27 | Source: Moneycontrol.com
Lupin's US subsidiary, Gavis Pharmaceuticals LLC., USA has received final approval for its Potassium Chloride Extended Release Capsules USP, 8 mEq (600 mg) and 10 mEq (750 mg) from the USFDA to market a generic equivalent of Actavis Labs FL, Inc's Potassium Chloride Extended Release Capsules USP, 8 mEq and 10 mEq.
Messages on Fda »

koppik

Gold Member

9 Followers

Biocon  

it says Nov 2016 is when final data comes in. So give a few months more, it should be Q1-18 before an EMA or FDA submission. unless the Japanese approval helps speed things up.

11.55 PM Aug 27th

analystnash
aq

Silver Member

2 Followers

Sun Pharma  

The US FDA is a one year old matter, aleardy resolved . Will not affect Sun Pharma in any way now....

4.23 PM Aug 27th

holybull

Silver Member

2 Followers

Claris Life  

US FDA related issues strikes Claris again. This time however management is confident of addressing FDA concerns within a fortnight.

1.30 PM Aug 27th

raregem

Platinum Member

724 Followers

Aurobindo Pharm  

One addl. point the management communicated on the conference call was that they have withdrawn 14 ANDA`s ( something similar to what Lupin did) in the pipeline with FDA as they felt the total cost of approval and the potential revenue and profits were not worth it. Good to see

6.52 PM Feb 9th 2013

raregem

Platinum Member

724 Followers

Aurobindo Pharm  

the fundamentals don`t change. Don`t look at the price movements on an hourly basis. And in 2 months, the fundamentals have only improved as FDA inspection is over of unit 4 and 6 and few approvals have come through. Give a single negative that has taken place fundamentally in the last few months? Lastly, Trade

1.59 PM Feb 7th 2013

RAJ BHATIA

Platinum Member

368 Followers

Aurobindo Pharm  

raregem,result is one day event,we should see future prospects of company,which looks very good to me.in q3 i am expecting 1500 cr sales and 250cr profit,but this is just bigning of story,we will see huge up move in sales and profit in coming quaters,lot of fda approvals and unit vi approval

3.15 PM Feb 6th 2013

RAJ BHATIA

Platinum Member

368 Followers

Aurobindo Pharm  

some of borders want to create fear of going blow 180,u r right nobody is afraid seeing to huge fda approvals,interm dividend and expecting good results in q3 and q4.long term investors will be rewarded nicely,some of members may ask why 231 before march and why 393 before deepawali,but hold

12.55 PM Feb 5th 2013

vcch

Silver Member

0 Follower

Aurobindo Pharm  

sun pharma upmove after us fda approval today... hope auro also follows suit.

11.40 AM Feb 5th 2013

arpitchinx

Silver Member

2 Followers

Strides Arcolab  

That`s my expectation. Results this quarter should be very good with the FDA approvals received in the last year, plus 3 new facilities commissioned. And whether it`s Pfizer or someone else, Agila will be sold before march

8.32 PM Jan 29th 2013

raregem

Platinum Member

724 Followers

Aurobindo Pharm  

it earlier too. This has no consequence on the price of Auro. Every pharma company gets these approvals on a routine basis. Your messages on price movements, unit 6 approval have all turned wrong! Lame excuses were given like FDA on vacation etc. Hence it is time to think for all boarders if you are meaning

12.53 PM Jan 28th 2013

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