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Food And Drug Administration

Jul 24, 2014 at 12:57 | Source: Moneycontrol.com
After inspecting the companys active pharmaceutical ingredients (APIs) manufacturing unit at Raltam, US Food and Drug Administration (US FDA) has raised some concerns in Form 483. Hence the drug manufacturer will suspend shipments to the US markets till the issue is addressed.
Jul 23, 2014 at 11:35 | Source: Moneycontrol.com
Strides Arcolab today announced that it has received approval from the United States Food & Drug Administration (USFDA) for Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg.
Jul 22, 2014 at 09:39 | Source: CNBC-TV18
Currently 34 percent of Indocos sales come from exports, with 10 percent from the US.
Jul 22, 2014 at 09:35 | Source: Moneycontrol.com
The US Food and Drug Administration (US FDA) has approved the sterile facility (plant-II) and solid dosage facility (plant -III) located at Verna in the adjoining coastal state, a company release said.
Jul 21, 2014 at 22:18 | Source: PTI
The US Food and Drug Administration (US FDA) has approved the sterile facility (plant-II) and solid dosage facility (plant -III) located at Verna in the adjoining coastal state, a company release said.
Jul 15, 2014 at 15:59 | Source: PTI
Glenmark Generics Inc USA, the subsidiary of Glenmark Generics Ltd, has been granted final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Fluocinonide cream USP (0.1 per cent), Glenmark Pharmaceuticals said in a statement.
Jul 15, 2014 at 10:54 | Source: Moneycontrol.com
Fluocinonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses, says Glenmark Pharma.
Jul 15, 2014 at 10:28 | Source: Moneycontrol.com
Glenmark Generics Inc., USA, the subsidiary of Glenmark Generics Limited, has been granted final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Fluocinonide Cream USP 0.1 percent, the generic version of Vanos Cream by Medicis.
Jul 14, 2014 at 10:45 | Source: Moneycontrol.com
Credit Suisse expects higher Food and Drug Administration (FDA) scrutiny during next inspection at Sun Pharmaceutical Industries' Halol facility.
Jul 09, 2014 at 10:59 | Source: Moneycontrol.com
Ahmedabad-based pharmaceutical company Claris Lifesciences received approval from United States Food and Drug Administration (USFDA) for its finished dosage plant and API plant.
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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

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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

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

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

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

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

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

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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

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

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

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