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Food And Drug Administration

Mar 25, 2015 at 14:26 | Source: Reuters
The company will look to invest more than USD 300 million in research and development and is not considering any job cuts post the close of the deal, Managing Director Dilip Shanghvi told reporters in Mumbai.
Mar 24, 2015 at 12:14 | Source: Moneycontrol.com
Shares of Aarti Drugs plunged nearly 17 percent intraday on Tuesday after the US Food and Drug Administration (USFDA) issued an import alert on companys Palghar unit in Maharashtra. However, the stock recovered some losses post clarification by the company saying this import alert won't have major impact on earnings.
Mar 19, 2015 at 18:25 | Source: PTI
Drug firm Aurobindo Pharma has received tentative approval from the US health regulator USFDA for its generic Lacosamide tablets used in treatment of partial seizures in epilepsy patients.
Mar 19, 2015 at 15:34 | Source: Moneycontrol.com
Shares of Lupin touched a record high of Rs 1,958 on Thursday, up 4.5 percent intraday. The US subsidiary received approval from US Food and Drug Administration (USFDA) for anti-inflammatory drug Celecoxib.
Mar 19, 2015 at 12:04 | Source: Moneycontrol.com
Shares of Wockhardt rallied 5.4 percent intraday Thursday after the US health regulator has not found any issues at Chikalthana plant.
Mar 18, 2015 at 19:05 | Source: PTI
Drug maker Wockhardt on Wednesday said the US health regulator has not found any issues with respect to data security and control measures at Chikalthana plant in a recent inspection.
Mar 17, 2015 at 11:45 | Source: Moneycontrol.com
Granules India shares extended rally on Tuesday, up 12 percent intraday to hit a record high of Rs 1,017.10 after the US drug regulator inspected company's Andhra Pradesh unit.
Mar 11, 2015 at 12:38 | Source: CNBC-TV18
The US Food and Drug Administration (FDA) has carried out inspection at two units of Shilpa Medicare at Raichur, MD Vishnukant Bhutada told CNBC-TV18 in an interview.
Mar 11, 2015 at 12:00 | Source: Moneycontrol.com
Investors lapped up more shares of Shilpa Medicare on Wednesday after the US Food and Drug Administration (US FDA) has inspected 2 manufacturing units at Raichur. The stock hit a life high of Rs 1,018.50, up 10 percent intraday.
Mar 10, 2015 at 17:45 | Source: PTI
The Supreme Court has declined to review the Federal Circuit's decision. The case remains pending in the District of New Jersey where the validity of US Patent No 5,763,483 continues to be challenged, 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 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

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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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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

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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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