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Food And Drug Administration

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 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 19, 2017 at 15:15 | Source: PTI
The United States Food and Drug Administration (USFDA) had conducted an inspection at the company's Unit III, a formulations manufacturing facility at Bachupally, Hyderabad from April 10, 2017 to April 18, 2017, Aurobindo Pharma said in a filing to BSE.
Apr 19, 2017 at 11:34 | Source: PTI
"Glenmark Pharmaceuticals Inc, USA has been granted tentative approval by the United States Food & Drug Administration (USFDA) for Dabigatran Etexilate Capsules, 75 mg, 110 mg and 150 mg," Glenmark Pharmaceuticals said in a BSE filing.
Apr 19, 2017 at 11:28 | Source: PTI
"The company has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for vilazodone hydrochloride tablets, 10mg, 20mg and 40mg," Alembic Pharma said in a BSE filing today.
Apr 18, 2017 at 13:02 | Source: Moneycontrol.com
Orchid Pharma received the establishment inspection report from the US Food & Drug Administration.
Apr 17, 2017 at 13:31 | Source: PTI
The bio-equivalence facility was inspected by US Food & Drug Administration (USFDA) from March 6-10; March 13-17 and April 10-12, Alembic said in a filing to BSE.
Apr 17, 2017 at 12:40 | Source: PTI
In a BSE filing, Unichem Laboratories said "it has received ANDA approval from the United States Food and Drug Administration (USFDA) for Piroxicam Capsules USP 10mg and 20mg".
Apr 12, 2017 at 11:40 | Source: Moneycontrol.com
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Messages on Food And Drug Administration »

makeprofitz

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Sun Pharma  

and Drug Administration (USFDA) recently. This inspection was completed on April 13, 2017, Sun Pharmaceutical Industries said in a BSE filing on Saturday. "A Form-483 observation letter was issued by the USFDA post the inspection, listing 11 observations," it added. The company, however, did not provide

9.32 PM Apr 22nd

makeprofitz

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index  

and Drug Administration (USFDA) recently. This inspection was completed on April 13, 2017, Sun Pharmaceutical Industries said in a BSE filing on Saturday. "A Form-483 observation letter was issued by the USFDA post the inspection, listing 11 observations," it added. The company, however, did

9.31 PM Apr 22nd

porfavor

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Sun Pharma  

Angel Broking maintained its BUY rating on Sun Pharmaceutical Industries with a price target of Rs 847, even as the pharma major received 11 observations the US Food and Drug Administration (FDA) for its Dadra unit, saying that these observations will not lead to any negative impact on the earnings

10.13 PM Apr 21st

porfavor

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Sun Pharma  

The U.S. Food and Drug Administration noted incomplete laboratory records among potential manufacturing violations it observed during an inspection of Sun Pharmaceutical Industries Ltd. s Dadra unit this month, according to an inspection report obtained by Bloomberg News. Other observations

9.36 PM Apr 21st

protraderin
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Tata Motors  

the company has received tentative approval from the us food and drug administration (usfda) for its abbreviated new drug application for vilazodone hydrochloride tablets, 10mg, 20mg and 40mg, alembic pharma said in a bse filing today.

12.59 PM Apr 20th

stockpicks2
017

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Alembic Pharma  

the company has received tentative approval from the us food and drug administration (usfda) for its abbreviated new drug application for vilazodone hydrochloride tablets, 10mg, 20mg and 40mg, alembic pharma said in a bse filing today.

12.58 PM Apr 20th

signalsindi
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Aurobindo Pharm  

the united states food and drug administration (usfda) had conducted an inspection at the company s unit iii, a formulations manufacturing facility at bapally, hyderabad from april 10 to april 18, 2017, aurobindo pharma said in a filing to bse.

12.09 PM Apr 20th

kalpataru70

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Aurobindo Pharm  

Drug firm Aurobindo Pharma today said the US health regulator has issued six observations for its Unit III formulations facility in Hyderabad. The United States Food and Drug Administration (USFDA) had conducted an inspection at the company s Unit III, a formulations manufacturing facility

3.23 PM Apr 19th

damanimarke
t

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Alembic  

the company has received tentative approval from the us food and drug administration (usfda) for its abbreviated new drug application for vilazodone hydrochloride tablets, 10mg, 20mg and 40mg, alembic pharma said in a bse filing today.

11.59 AM Apr 19th

lizzy

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Claris Life  

a significant majority of net cash proceeds from the sale, post expenses and taxes, with shareholders. Claris operated the global generic injectables business through several wholly-owned subsidiaries. It has a total of 40 abbreviated new drug applications filed with the US Food and Drug Administration (FDA

10.28 AM Apr 18th

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