Food And Drug Administration

Jun 20, 2015 at 13:48 | Source: PTI
FMCG firm RB said it will do a thorough investigation and collaborate with authorities after the UP Food and Drug Administration alleged a lesser weight in its Dettol soap.
Jun 19, 2015 at 13:10 | Source: Moneycontrol.com
"US Court of Appeals for Federal Circuit has again found Teva's US 808 patent for Copaxone to be invalid as indefinite. The company awaits approval from the US Food and Drug Administration (US FDA) to launch the product," said Natco in its filing to the exchange.
Jun 18, 2015 at 10:12 | Source: Moneycontrol.com
"Orchid has received approval from the USFDA for the abbreviated new drug application (ANDA) for Gemifloxacin Mesylate tablets (320 mg) with 180 days of generic drug exclusivity," said the drug maker in its filing.
Jun 17, 2015 at 21:42 | Source: PTI
A day after the UP Food and Drug Administration said it had found detergent in one of the milk samples of Mother Dairy, the co-operative said the tested was done on "loose milk samples collected at village level" which were yet to be accepted by it.
Jun 17, 2015 at 18:50 | Source: PTI
The company has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Gemifloxacin Mesylate tablets in the strength of 320 mg, Orchid Chemicals & Pharmaceuticals said in a filing to BSE.
Jun 16, 2015 at 20:43 | Source: PTI
A UP FDA official said that the results showed samples were of sub-standard quality and one of the two samples contained detergent in it.
Jun 16, 2015 at 11:18 | Source: Moneycontrol.com
Hyderabad-based Aurobindo Pharma has received the final approval from the USFDA to manufacture and market extended Phenytoin sodium capsules USP, 100mg.
Jun 15, 2015 at 17:46 | Source: PTI
Glenmark Pharmaceuticals USA has been granted final approval by the United States Food & Drug Administration (USFDA) for the "extended-cycle oral contraceptive Levonorgestrel and Ethinyl Estradiol tablets USP 0.15 mg/0.03 mg," Glenmark Pharmaceuticals said in a statement.
Jun 15, 2015 at 17:28 | Source: PTI
The product has an estimated market size of USD 125 million for 12 months ended April 2015, Aurobindo Pharma said quoting IMS data.
Jun 15, 2015 at 17:27 | Source: PTI
The Department of Agriculture of the Australian government has issued a "holding order" against Maggi as a precautionary measures on June 11. "The purpose of this notice is to advise that the department has applied a holding order to Maggi brand noodles (Maggi noodles) from India".
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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

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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
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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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416 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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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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