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Food And Drug Administration

Nov 18, 2014 at 14:55 | Source: Reuters
In the suit filed in the District Court for the District of Columbia, Ranbaxy said the FDA's move violated constitutional rights, exceeded the agency's statutory authority, and was "arbitrary, capricious, and otherwise contrary to law."
Nov 12, 2014 at 12:42 | Source: Reuters
Cadila Pharmaceuticals is the latest Indian drugmaker to face US regulatory rebuke, as the FDA intensifies its scrutiny of the generic drugmakers.
Nov 12, 2014 at 08:34 | Source: Reuters
India's USD 15 billion pharmaceutical industry, which has been hit by a spate of regulatory sanctions in the past year due to concerns about production processes, supplies about 40 percent of generic and over-the-counter drugs to the United States.
Nov 07, 2014 at 11:21 | Source: Reuters
The US Food and Drug Administration (FDA) said it has granted final approval to Indian drugmaker Dr Reddy's Laboratories and US firm Endo International Plc to make cheaper copies of Roche Holding AG's antiviral Valcyte.
Nov 05, 2014 at 11:52 | Source: Moneycontrol.com
According to the Credit Suisse, Form 483 for the Indore SEZ suggests Food and Drug Administration (FDA) observations are critical and could delay recovery of US sales.
Sep 16, 2014 at 14:23 | Source: Moneycontrol.com
"Zydus Cadila has received tentative approval from the US Food and Drug Administration (US FDA) to market (anti-diabetic drug) Glipizide extended release tablets in the strength of 2.5 mg, 5 mg and 10 mg," said the company in its filing.
Sep 11, 2014 at 09:56 | Source: Moneycontrol.com
Sources say Sun Pharma was taken by surprise when a team of 5 inspectos of United States Food and Drug Administration (US FDA) walked in on Monday morning for inspection that is still ongoing.
Sep 01, 2014 at 12:08 | Source: Moneycontrol.com
Two drugs -- WCK 771 and WCK 2349 -- have received QIDP status, which allows fast-track review of the drug application by the US Food and Drug Administration (USFDA), Wockhardt said in a statement. This is the first instance of an Indian pharmaceutical company receiving QIDP status, it added.
Sep 01, 2014 at 11:06 | Source: CNBC-TV18
"Marketing partner in the USA, Mylan Inc has filed an abbreviated new drug application (ANDA) for a three-times-a-week generic Copaxone (glatiramer acetate injection, 40 mg/ml) and has been accepted by the US Food and Drug Administration (US FDA)," said the company in its filing.
Aug 31, 2014 at 19:07 | Source: PTI
Two drugs -- WCK 771 and WCK 2349 -- have received QIDP status, which allows fast-track review of the drug application by the US Food and Drug Administration (USFDA), Wockhardt said in a statement. This is the first instance of an Indian pharmaceutical company receiving QIDP status, it added.
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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
a

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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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282 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

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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