SENSEX NIFTY

Food And Drug Administration

Jan 23, 2015 at 15:12 | Source: Moneycontrol.com
Investors offloaded a huge chunk of shares of Ipca Laboratories on Friday. The stock fell nearly 9 percent intraday. The pharmaceutical firm received import alert from US Food and Drug Administration for its Ratlam unit due to violations of standard production practices.
Jan 07, 2015 at 09:59 | Source: Moneycontrol.com
"Aurobindo received final approval from the US Food & Drug Administration to manufacture and market Valsartan tablets USP, 40mg, 80mg, 160mg and 320mg. The product is ready for launch," said the pharmaceutical company in its filing to the exchange.
Jan 06, 2015 at 18:47 | Source: PTI
The companies have received final approval from the US Food and Drug Administration (USFDA) for their abbreviated new drug applications for Valsartan tablets USP in multiple strengths of 40 mg, 80 mg, 160 mg and 320 mg, domestic firms said in separate statements.
Jan 06, 2015 at 11:09 | Source: Moneycontrol.com
"Jubilant received abbreviated new drug application (ANDA) final approval from the US Food and Drug Administration (US FDA) for Mycophenolate Mofetil USP and Rizatriptan," said the pharmaceuticals and life sciences company in its filing to the exchange.
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.
Messages on Food And Drug Administration »

BSE/NSE Announcer

Platinum Member

6171 Followers

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

Platinum Member

6171 Followers

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

Platinum Member

253 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

Platinum Member

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 2014

Amrita Gaba

New Member

401 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

Platinum Member

315 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

Platinum Member

315 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 2014

Web Messenger

Platinum Member

266013 Followers

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

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 2014

shakira9

New Member

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 2014