SENSEX NIFTY

Usfda

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.
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 08, 2017 at 11:00 | Source: PTI
Glenmark said it plans to initiate clinical development with a phase two study of GSP 304, a new orally administered formulation, in subjects with mild to moderate COPD, as determined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
Mar 08, 2017 at 10:56 | Source: Moneycontrol.com
Cadila Healthcare has received final approval from the USFDA to market Tizanidine Hydrochloride capsules, USP in strength of 2 mg, 4m g and 6 mg.
Mar 08, 2017 at 09:25 | Source: Moneycontrol.com
The US drug regulator cleared the companys investigational new drug application to begin phase two study of GSP 304 that will be used to treat chronic obstructive pulmonary disease.
Mar 07, 2017 at 22:38 | Source: CNBC-TV18
The US drug regulator USFDA has issued a warning letter to the Mumbai-based pharma company Wockhardt for its Morton Grove facility in the country.
Messages on Usfda »

cindrella20
04

Platinum Member

1965 Followers

Torrent Pharma  

Dear San, DIVIS is among the best pharma stocks,what was shocking in the case of DIVIS,was overwhelming faith the market and the investors have on this stock.The USFDA issue was like a bolt from the blues for DIVIS. I do not need to say any encouraging words,past performance and the track record

about 2 hrs 4 min 1 sec ago

PANIC-PANIC

New Member

1 Followers

Nectar Life  

divis labs effect seen on most pharma companies... its not easy to get thru USFDA... this is heading to 32-33 in next week... inspite of having good results for last qtr, it has continued its downward journey which has flummoxed many investors... can expect some move only after next qtr results

about 4 hrs 23 min 51 sec ago

PANIC-PANIC

New Member

1 Followers

Divis Labs  

it seems 600 might be breached on Monday... situation don`t seem to be rosy for DIVIL... better to wait & watch till it stabilizes & see how the management is going to tackle USFDA concerns/reservations... in any case, max of 10 % slip can be expected, because its impossible that every investor

about 7 hrs 18 min 1 sec ago

ravisk

Silver Member

127 Followers

Wockhardt  

will move in the days ahead. Take Divis Labs crash as the most recent example of this point. Wockhardt is actually no better, it may even be worse, compared to Divis in terms of USFDA adverse observations, hence, my PUTs in the stock.

about 7 hrs 46 min 42 sec ago

savera_patn
a

Platinum Member

40 Followers

Biocon  

Thereafter September/October timeline for Trastuzumab/Pegfilgrasim by USFDA...exiting times ahead

about 8 hrs 48 min 14 sec ago

aishvaraya7
5

New Member

14 Followers

Divis Labs  

through the conference call the management may try to assuage the investor concerns though I feel it may be of limited use since the mgmt itself is caught unawares why the alert is issued under section 91-32 which is a very serious statement & also the upcoming USFDA inspection of Unit 1 which

8.15 PM Mar 24th

BSE/NSE Announcer

Platinum Member

21943 Followers

Divis Labs  

Notice is hereby given that, the Analyst/ Investor Conference call is scheduled at 11.00 am IST on March 27, 2017 where Companys Management will discuss and answer questions from participants w.r.t Import Alert received by the Company from US-FDA. The operator will provide instructions on asking

6.13 PM Mar 24th

CHANAKYA 123

New Member

12 Followers

Aurobindo Pharm  

This is One of the best Drug USFDA`s Auro has received till date most commercially viable and high yielding drug

5.30 PM Mar 24th

San1220

New Member

0 Follower

Torrent Pharma  

Dear Cindrellaji....Namaskar..would like to have encouraging words on Divis..I entered into divis following your relentless appreciation and kept on adding till today. How do you see the issue especially with usfda clause 99-33? thanks

4.38 PM Mar 24th

kalpataru70

Platinum Member

540 Followers

Aurobindo Pharm  

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture Guaifenesin and Dextromethorphan Hydrobromide extended-release tablets, 600/30 mg and 1200/60mg (OTC). Aurobindo s Guaifenesin

4.02 PM Mar 24th

News across the web »
Follow us on
Available On