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About 966 results for "usfda"

Ipca Laboratories: Getting Back on its Feet
Value Research Online

Ipca Laboratories: Getting Back on its Feet

Having faced reprimands from the USFDA over regulatory violations, Ipca Labs is recovering from the setback and gearing up for a bull run By Vikas Vardhan | Apr 1, 2015 Ipca Laboratories is into pharmaceutical formulations and APIs (active pharmaceutical ... Value Research Online, 11 hours ago
Hold Ipca Laboratories: Sharekhan, 6 days ago
Hold Ipca Laboratories: ICICIdirect, 1 week ago

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India Infoline

Aurobindo Pharma receives USFDA Tentative Approval for Lacosamide Tablets

Posted On: 2015-03-22 21:28:20 Aurobindo Pharma Limited has announced that US Food & Drug Administration (USFDA) has granted the tentative approval for Lacosamide Tablets 50mg, 100mg, 150mg and 200mg (ANDA 204994). Lacosamide Tablets are the ...
 Equity Bulls1 week ago Aurobindo gets tentative nod from USFDA for Lacosamide tablets  ZeeNews.com1 week ago Aurobindo Pharma gets USFDA nod for Lacosamide tablets  MyIris1 week ago USFDA plans to shift to an incentive based from a penalty based audits  Economic Times2 weeks ago
India Infoline

Ipca Lab gets import alert from USFDA: What experts say

The USFDA has imposed import alerts on Silvassa and Indore (formulation facilities for US) for IPCA. However, Hydroxychloroquine Sulfate and Propanolol Hydrochloride, which accounted for around 45% of its total US sales in FY2014, are exempted from the ban.
 Myiris1 week ago IPCA Labs gets import alert from USFDA for Ratlam plant: Reports  India Infoline2 months ago

IPCA Labs plunges over 11% on USFDA alert

MUMBAI: Shares of IPCA Laboratories plunged over 11 per cent in early trade following reports that the company has received US FDA import alert at two manufacturing facilities. According to USFDA, IPCA Labs' unit in Pithampura (MP) and Piparia ...
 Economic Times1 week ago
Business Standard

Lupin hits new high on USFDA nod for anti-inflammatory drug

Shares of Lupin touched a record high of Rs 1,958 on Thursday, up 4.5 percent intraday. The US subsidiary received approval from US Food and Drug Administration (USFDA) for anti-inflammatory drug Celecoxib.
 Money Control1 week ago Granules India scales record high  Capital Market2 weeks ago Granules India hits new high, up 12% post USFDA inspection  Money Control2 weeks ago Granules India hits record high post USFDA inspection of Gagillapur facility  Business Standard India2 weeks ago
Money Today

Wockhardt's Chikalthana plant to regain the lost ground soon

In 2013, the USFDA had issued an import alert on the company's Aurangabad-based Waluj and Chikalthana facilities Wockhardt Pharma's Chikalthana facility in Maharashtra recently underwent a 10-day-long inspection by the USFDA and the company ...
 Financial Express1 week ago USFDA did not find issues with Wockhardt's Chikalthana plant  Money Today2 weeks ago Granules soars 12% as USFDA gives clean chit to unit  Economic Times2 weeks ago Wockhardt up 5%, USFDA gives clean chit to Chikalthana unit  Money Control1 week ago
Money Today

We should be able to recover 50-60% sales from Chikalthana: Habil Khorakiwala, Wockhardt

A day after Wockhardt said that the recent USFDA's follow-up inspection was to assess the progress made in areas of good manufacturing practices remediation and robust quality management, founder chairman and group CEO Habil Khorakiwala told FE's ...
 Financial Express1 week ago Wockhardt Ltd clarifies on USFDA concern over Waluj plant  Equity Bulls1 month ago Addressing USFDA concerns over Waluj unit, says Wockhardt  Business Standard1 month ago USFDA raises fresh concerns about Wockhardt's Waluj plant  Money Today1 month ago

Expect US FDA to visit remaining facilities soon: Wockhardt

H Khorakiwala said the company will respond to queries on Form 483 in next few months. The USFDA is expected to visit the remaining facilities soon. Watch video for the entire press conference Wockhardt stock price On March 19, 2015, at 12:54 ...
 Moneycontrol.com1 week ago No grave observations made in USFDA Waluj visit: Wockhardt  Money Control1 month ago

Will USFDA'S new proposals help Indian pharma companies?

Posted by Equitymaster The spate of import alerts, warning letters on the Indian pharma manufacturers by US Food and Drug Administration (USFDA) have been increasing over last few years . More recently, there have been just few companies who have received ...
 Equitymaster.com1 week ago Pharma companies will soon be rated by USFDA  Hindu Business Line2 weeks ago

Aurobindo gets US FDA nod for Lacosamide tablets

Aurobindo Pharma Ltd has received tentative approval from the US Food and Drug Administration (USFDA) for Lacosamide tablets. They are the generic equivalent of USB Inc's Vimpat tablets and are used in the treatment of partial-onset seizures in ...
 Hindu Business Line1 week ago
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