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Us Food And Drug Administration

Jun 27, 2016 at 10:08 | Source: Moneycontrol.com
This is depite the fact that exports revival in its US and institutional businesses seems distant as the US- Food and Drug Administration (FDA) regulatory issues are likely to remain unresolved in the next two years.
Jun 23, 2016 at 10:18 | Source: Moneycontrol.com
Share prices of Natco Pharma rose 8 percent intraday Thursday on the back of approval received from USFDA for Glycopyrrolate oral tablets.
Jun 23, 2016 at 09:32 | Source: PTI
Company's US subsidiary Gavis Pharmaceuticals LLC has received final approvals to market "its Voriconazole tablets, 50 mg & 200 mg and Voriconazole Oral Suspension, 40 mg/mL from the United States Food and Drug Administration (FDA)," Lupin said in a filing to BSE.
Jun 18, 2016 at 10:36 | Source: PTI
The pact would "allow EIC (Export Inspection Council) to conduct quick cause analysis in time to support the Indian exporter," the commerce and industry ministry said in a tweet.
Jun 14, 2016 at 11:58 | Source: PTI
The US Food and Drug Administration (USFDA) has so far granted final approvals for 10 abbreviated new drug applications (ANDAs) and 2 tentative approvals, it said, adding that an additional 14 ANDAs are under review.
Jun 14, 2016 at 11:39 | Source: Moneycontrol.com
United States Food & Drug Administration has granted Ajanta Pharma 10 final approvals and 2 tentative approvals for its abbreviated new drug application, it said, adding another 14 ANDAs are pending approval from the USFDA.
Jun 13, 2016 at 15:54 | Source: PTI
Gupta said in the eventuality of FDA holding back approvals from the Goa facility, it will not affect its business as majority of the 100 approvals pending with the FDA now are from non-Goa sites.
Jun 07, 2016 at 14:05 | Source: Moneycontrol.com
"Oral dosage forms manufacturing site in Bangalore has received the establishment inspection report (EIR) from the US Food & Drug Administration, thereby confirming the closure of the inspection. The facility continues to be US FDA Approved," the pharma company said in its filing.
Jun 06, 2016 at 12:52 | Source: Moneycontrol.com
"The US Food & Drug Administration has approved company's plan to initiate a phase 2 clinical trials of Saroglitazar (Lipaglyn) in patients with non-alcoholic steatohepatitis (NASH) of the liver in USA," the Ahmedabad-based pharma company says in its filing.
Jun 03, 2016 at 14:44 | Source: PTI
The company's marketing partner Mylan Inc has received a tentative approval from the United States Food and Drug Administration (USFDA) for abbreviated new drug application (ANDA) for Sorafenib tablets in the strength of 200 mg, Natco Pharma said in a filing to BSE.
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ahaslaltirm
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Wockhardt  

Jun 05, 2014, 04.15 PM IST | Source: PTI Wockhardt recalls 8712 hypertension drug bottles in US mkt According to US Food and Drug Administration (USFDA), Wockhardt USA Inc, a subsidiary of Mumbai-based firm is voluntarily recalling 8,712 bottles of the drug in the American market.

10.30 AM Jul 7th 2014

Neha-Diwan

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Ranbaxy Labs  

Ranbaxy Laboratories Ltd has received approval from the US Food and Drug Administration (FDA) to launch a cheaper copy of Novartis AG`s blood pressure pill Diovan. Ranbaxy will be the first rival drug maker to launch a copy of Diovan in the United States and will be entitled to six months

10.20 AM Jun 30th 2014

Amrita Gaba

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Strides Arcolab  

Strides Arcolab has received regulatory approval to market a skin disease drug in the US. The US Food and Drug Administration (FDA) has allowed the company to sell Methoxsalen capsules of 10 mg strength, Bangalore-based Strides Arcolab said in a statement. The US market for generic Methoxsalen

12.33 PM Jun 9th 2014

Willwin

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Wockhardt  

he U.S. Food and Drug Administration has expressed concerns over production processes at the U.S. unit of Wockhardt and there is a real possibility that its USA unit is banned by USFDA. If that happens the share will sink below 400. For the time being IMO,it will go down to 450-500 range.

10.16 AM May 29th 2014

Willwin

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Wockhardt  

1.01 PM May 28th 2014

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Wockhardt  

Source:NDTV Profit - Mumbai: The US Food and Drug Administration (FDA) has made some observations about the production process of the US unit of Indian generic drugmaker Wockhardt Ltd, the company said on Tuesday. The FDA last year banned Wockhardt's two Indian ...

7.12 PM May 27th 2014

shakira9

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Sun Pharma  

to increased scrutiny from regulators concerned that the quality of drugs made in that country aren’t up to US standards. The concerns prompted Margaret Hamburg, the commissioner of the US Food and Drug Administration (FDA), to go to India in February to meet with pharmaceutical makers there about production

12.14 PM May 15th 2014

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News Now  

Source:Money Rediff News Report - New Delhi: India is launching a campaign to repair its reputation as a global supplier of cheap high-quality drugs, responding to bans imposed by US Food and Drug Administration (FDA) on several suppliers, two top officials said on Tuesday. As part of

2.34 PM May 7th 2014

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News Now  

Source:Calcutta Telegraph News - New Delhi, May 6: Problems faced by Indian drug makers in the US are not related to quality but to documentation and data maintenance, a senior government official said today. Stressing that India is already engaged with the US Food and Drug Administration (USFDA

1.48 PM May 7th 2014

arvinddhaka
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of Fall in the gearing level, Higher earnings growth, Removal of US Food and Drug Administration. We would like to assigned Buy rating to APL with a target price of Rs700 in one to two months.

6.33 PM Apr 23rd 2014

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