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Food And Drug Administration

Jun 27, 2016 at 11:59 | Source: Moneycontrol.com
Sun Pharmaceutical Industries has received tentative USFDA nod for Dalfampridine tablets.
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 24, 2016 at 14:24 | Source: PTI
The company has "received abbreviated new drug application (ANDA) approval from the United States Food and Drug Administration (USFDA) for Donepezil Hydrochloride tablets USP," Unichem Laboratories said in a filing to BSE.
Jun 24, 2016 at 13:20 | Source: Moneycontrol.com
Unichem Laboratories Limited is pleased to announce that it has received ANDA approval fromthe United States Food and Drug Administration (USFDA) for Donepezil Hydrochloride TabletsUSP.
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 16, 2016 at 15:04 | Source: PTI
In a regulatory filing, the company said after inspection, the FDA has passed an order to suspend manufacturing licences at Mahad unit for 15 days, from July 1 to July 15, 2016.
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.
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BSE/NSE Announcer

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Glenmark  

Glenmark Generics Inc., USA a subsidiary of Glenmark Generics has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (US FDA) for Telmisartan Tablets. Glenmark will commence distribution of the product immediately.

12.04 PM Jul 8th 2014

BSE/NSE Announcer

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Glenmark  

the United States Food and Drug Administration (US FDA) for Telmisartan Tablets. Glenmark will commence distribution of the product immediately.

12.04 PM Jul 8th 2014

ahaslaltirm
a

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774 Followers

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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5345 Followers

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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409 Followers

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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805 Followers

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  

Reuters) - The U.S. Food and Drug Administration has expressed concerns over production processes at the U.S. unit of Wockhardt Ltd (WCKH.NS), a top executive said, possibly adding to a spate of regulatory troubles facing the Indian generic drugmaker. The United States is Wockhardt`s biggest

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

teeyen

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Natco Pharma  

before the patent on the medication expires. Teva’s lawsuit, accusing the Food and Drug Administration of improperly dismissing its calls for more testing of generic forms of Copaxone before they go on the U.S. market, was thrown out yesterday by a federal judge in Washington. Copaxone, the company

4.09 PM May 18th 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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