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Food And Drug Administration

Dec 16, 2014 at 16:41 | Source: PTI
The company has launched Valganciclovir tablets, USP in the strength of 450 mg in the US market on December 15, 2014 and the product has been approved by the United States Food and Drug Administration (USFDA), Dr Reddy's Laboratories said in a filing to the BSE today.
Dec 09, 2014 at 08:38 | Source: PTI
As per information available on the USFDA website, Zydus Pharmaceuticals USA Inc, the US-based arm of the company, is recalling the drug due to "discoloration".
Dec 08, 2014 at 21:14 | Source: PTI
The nationwide recall has been initiated by the company on October 1 this year and has been initiated under Class-III which FDA defined as "a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences".
Dec 04, 2014 at 20:32 | Source: Reuters
European authorities inspected all units at Ranbaxy's Dewas plant, in Madhya Pradesh, in June and did not approve the manufacturing practices at the unit that makes injectable cephalosporin antibiotics, Ranbaxy said in a stock market filing on Thursday.
Dec 02, 2014 at 08:34 | Source: Moneycontrol.com
Sun Pharma Advanced Research Company announced that the US Food and Drug Administration (FDA) has issued a Complete Response letter to its New Drug Application (NDA) for Latanoprost BAK-free eyedrops.
Nov 26, 2014 at 13:38 | Source: CNBC-TV18
The Vizag plant, which manufactures active pharmaceutical ingredient (API) and bulk drugs, was visited by the US Food and Drug Administration last week.
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.
Messages on Food And Drug Administration »

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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

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

ahaslaltirm
a

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221 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

Neha-Diwan

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805 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

Amrita Gaba

New Member

402 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

Willwin

Platinum Member

296 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

Platinum Member

296 Followers

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

Silver Member

2 Followers

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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3 Followers

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