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Apr 25, 2017 at 22:14 | Source: CNBC-TV18
CNBC-TV18 accessed the form 483 which includes the two observations. While the first observation says that the pharma major's Srikakulam lab records do not include a complete record of all data, the second reads that the Srikakulam site does not always maintain complete records.
Apr 25, 2017 at 14:36 | Source: PTI
The company has received "final approval from the United States Food and Drug Administration (USFDA) to market olmesartan medoxomil tablets in the strengths of 5 mg, 20 mg and 40 mg", Cadila Healthcare said in a filing to BSE. The drug is an anti-hypertensive and will be produced at the group's formulations manufacturing facility in Ahmedabad, it added.
Apr 25, 2017 at 13:54 | Source: Moneycontrol.com
Zydus Cadila has received final approval from the USFDA to market Olmesartan Medoxomil tablets in strength of 5 mg, 20 mg and 40 mg.
Apr 25, 2017 at 11:30 | Source: PTI
"The company has received abbreviated new drug application (ANDA) final approval for olmesartan medoxomil tablets, 5 mg, 20 mg, and 40 mg and olmesartan medoxomil with hydrochlorothiazide tablets 20/12.5mg, 40/12.5mg and 40/25mg," Alembic Pharmaceuticals said in a BSE filing today.
Apr 25, 2017 at 11:15 | Source: PTI
In a BSE filing, the company said it has received abbreviated new drug application (ANDA) final approval for olmesartan medoxomil tablets - 5 mg, 20 mg, and 40 mg.
Apr 25, 2017 at 11:05 | Source: Moneycontrol.com
This is second approval that company has received from the USFDA during the current financial year.
Apr 25, 2017 at 10:32 | Source: Moneycontrol.com
Alembic Pharmaceuticals has received final approvals from the USFDA for its ANDAs for Olmesartan Medoxomil tablets, 5 mg, 20 mg, 40mg and Olmesartan Medoxomil with Hydrochlorothiazide tablets 20/12.5 mg, 40/12.5 mg and 40/25mg.
Apr 22, 2017 at 15:19 | Source: PTI
Drug firm Divis Laboratories today said the US health regulator has issued a warning letter to the company for its Vishakhapatnam facility.
Apr 21, 2017 at 09:57 | Source: Moneycontrol.com
Dadra site is the biggest unit for the compay after Halol plant, for supplying drug in the United States.
Apr 19, 2017 at 15:31 | Source: Moneycontrol.com
Aurobindo Pharma on Wednesday said it has received a Form 483 with six observations from United States Food and Drug Administration (US FDA) for its Unit-III formulation facility located at Bachupally in Hyderabad.
Messages on Usfda »

hushaam1

Gold Member

4032 Followers

Bayer CropScien  

of 1.5% SL triggerred if any, boarders creates tantrums with loud horns. Hence, I stopped providing any more multi baggers, so please donot insist for same in future. Regarding Sun Pharma has recently received 11 critical observations from USFDA on its Dadra unit due to which pressure can be seen

10.15 PM Apr 25th

mohveer

New Member

1 Followers

Marksans Pharma  

Hi, thanks for your clarification. i was just wondering about the USFDA Warning. Now, the picture is clear and i think the stock will witness huge up move shortly.

8.15 PM Apr 25th

vipul939

Gold Member

225 Followers

Jubilant Life  

Jubilant life science is also in process to get approval for USFDA for their Dahej SEZ plant......... So very soon within 6 month they will get the approval..... So be ready for 1000 very soon.....

7.58 PM Apr 25th

techsa1

New Member

88 Followers

Syncom Formula  

tomorrow who is taking over syncom formula? i think usfda reached syncom office?

5.27 PM Apr 25th

steve74

New Member

149 Followers

Lupin  

Generic Temovate Clobetasol Propionate Scalp application in the US. feb 28: Lupin receives FDA approval for Generic Percocet tablets. Also receives FDA approval for Generic Suprep Bowel Prep kit. feb 27: Astellas and Lupins subsidiary Kyowa enter into an agreement. feb 16: Lupin receives final USFDA

2.18 PM Apr 25th

nidhiarora-
2019

New Member

19 Followers

Just Posted  

aurobindo pharma aims to achieve the goals of wider access to hiv treatment, care and support, halting and reversing the spread of hiv and contributing to the aurobindo pharma gets usfda nod for hiv treatment drug

1.58 PM Apr 25th

nidhiarora-
2019

New Member

19 Followers

Aurobindo Pharm  

aurobindo pharma aims to achieve the goals of wider access to hiv treatment, care and support, halting and reversing the spread of hiv and contributing to the aurobindo pharma gets usfda nod for hiv treatment drug

1.57 PM Apr 25th

ammarcool

New Member

14 Followers

Syncom Formula  

hahahaha biocon naye story.....usfda story....hahah.....

1.49 PM Apr 25th

i4insignia

New Member

4 Followers

Aurobindo Pharm  

usfda inspection may have untoward observations in aurobindo`s unit iv hyderabad plant. a lot of us sales is dependent on this plant which will have a severe dent on the next 2 quarter numbers and overall profitability

1.41 PM Apr 25th

deltafol

New Member

2 Followers

Torrent Pharma  

there is no move expected till usfda news come out. it can then reach 1550 or 1200 based on that. result is not a trigger anymore.

12.56 PM Apr 25th

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