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Apr 22, 2017 at 13:26 | Source: CNBC-TV18
In a setback for Divi's Lab, the US FDA has issued a warning letter for the company's unit-II at Visakhapatnam. Ekta Batra has more details.
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.
Apr 17, 2017 at 12:42 | Source: Moneycontrol.com
Alembic Pharma's Bioequivalence facility located at Baroda was inspected by USFDA between March 6 & 10 2017, between March, 13 & 17 2017 and between April 10, to April 12, 2017 for a)Bioequivalence Clinical b)Bioequivalence Bioanalytical c)Pharmacovigilance. There were no 483s issued by US FDA at the end of the inspection.
Apr 17, 2017 at 12:42 | Source: Moneycontrol.com
Alembic Pharma's Bioequivalence facility located at Baroda was inspected by USFDA between March 6 & 10 2017, between March, 13 & 17 2017 and between April 10, to April 12, 2017 for a)Bioequivalence Clinical b)Bioequivalence Bioanalytical c)Pharmacovigilance. There were no 483s issued by US FDA at the end of the inspection.
Apr 17, 2017 at 10:12 | Source: CNBC-TV18
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Apr 15, 2017 at 12:13 | Source: Moneycontrol.com
The US FDA audit was conducted at its active pharmaceutical ingredient (API) Srikakulam special economic zone plant, from April 10 14.
Apr 14, 2017 at 15:50 | Source: CNBC-TV18
The US FDA has recorded 11 observations at Sun Pharmaceutical's Dadra based formulations manufacturing site.
Apr 13, 2017 at 20:59 | Source: PTI
During the inspection, the FDA investigator observed specific violations such as the quality system not fully ensuring data integrity, the regulator said.
Apr 13, 2017 at 16:12 | Source: CNBC-TV18
Lupin's Goa plant have had two inspections earlier which have resulted in nine observations each for both of those inspections. They have managed to successfully resolve that. Now, CNBC-TV18 learns that this particular facility got re-inspected by the US-FDA the inspection ended last week - and they have received an approval for an anti-depressant Wellbutrin XL generic and is a difficult drug to manufacture right after the inspection got over.
Apr 12, 2017 at 11:40 | Source: Moneycontrol.com
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Messages on Fda »

News Flash

Platinum Member

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Just Posted  

Strides Shasun : US FDA Inspected API Facility At Cuddalore With Zero Observations

about 2 hrs 41 min 49 sec ago

BSE/NSE Announcer

Platinum Member

22585 Followers

Strides Shasun  

Strides Shasun Limited has informed the Exchange regarding Completion of US FDA inspection at the API Facility of the Company at Cuddalore with Zero 483 observations.

about 2 hrs 44 min 10 sec ago

BSE/NSE Announcer

Platinum Member

22585 Followers

Strides Shasun  

Completion of US FDA inspection at the API Facility of the Company at Cuddalore with Zero 483 observations

about 2 hrs 50 min 14 sec ago

Vik11

New Member

1 Followers

Aurobindo Pharm  

no matter what you do the fda will always find issues. it`s how grave the issues raised are that matters. promoters still hold >50% stake. pharma is doing badly because of unfavorable conditions in us and not because these companies have suddenly become ill managed. same as it. it`s a good time

about 3 hrs 24 min 52 sec ago

viru.sonu

Silver Member

6 Followers

Orchid Pharma  

US FDA approved .nowwww multyyyy begggerrrr

about 3 hrs 36 min 2 sec ago

Infosys  

Infy ever green no NPA fda issue only cash rich

about 4 hrs 25 min 1 sec ago

StockDrifte
r

New Member

56 Followers

Divis Labs  

A warning letter cannot be worse than an import alert. Makes no sense that FDA issues a warning letter after giving an import alert. Rightly so, market has not reacted.

about 4 hrs 31 min 24 sec ago

prashantk87

New Member

1 Followers

Divis Labs  

entire pharma is down today.. basis to fda result it will surely go down...time to move our of it..

about 5 hrs 46 min 40 sec ago

vicks76

New Member

0 Follower

Vikas Ecotech  

in their pipes. vikas has fda approvals in place. they can export to usa with no issues. india will also follow suit by adopting lead free chemicals in pipes manufacturing. the pipes segment will continue to grow in the coming years. i will not be surprised if the stock trades around 200 in 5 years time

about 7 hrs 11 min 25 sec ago

nik76

New Member

2 Followers

Syncom Formula  

i really dont care whether you believe me or not. i dont come here everyday and confuse people. i am not a big player and 75% of my investment in sf and thats why i am tracking this company my own way... just remember my 4 points%u2026.1) third and final visit of us fda is due in 2017 2) recently

about 7 hrs 25 min 48 sec ago

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