Food And Drug Administration

Feb 09, 2016 at 16:42 | Source: PTI
The drug major had received a warning letter on November 5, 2015 from the USFDA regarding deviations from current good manufacturing practices (CGMP) at its active pharmaceutical ingredient (API) facilities at Srikakulam, Andhra Pradesh and Miryalaguda in Telangana
Feb 08, 2016 at 11:30 | Source: PTI
The company added the commercial launch of the product is planned for the coming quarter.
Feb 03, 2016 at 14:28 | Source: PTI
The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Isosulfan Blue injection 1 percent (50 mg/5 mL) single-dose vials, Aurobindo Pharma said in a statement.
Feb 03, 2016 at 11:28 | Source: Moneycontrol.com
This is third approval received by the company in the last two days. Yesterday, the company had received two approvals from USFDA to manufacture and market Celecoxib Capsules and Levetiracetam Injection USP.
Feb 03, 2016 at 10:47 | Source: Moneycontrol.com
Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Isosulfan Blue Injection, 1% (50 mg/5 mL) single-dose vials.
Feb 02, 2016 at 13:06 | Source: PTI
The approval for single-dose vials of Levetiracetam injection from the US Food and Drug Administration (USFDA) is bioequivalent and therapeutically equivalent to the reference listed drug product, Keppra Injection, 500 mg/5 mL (100 mg/mL), of UCB, Inc, Aurobindo Pharma said in a BSE filing.
Feb 02, 2016 at 12:07 | Source: Moneycontrol.com
Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg. This product is expected to be launched in Q4 FY15-16.
Feb 02, 2016 at 09:57 | Source: Moneycontrol.com
The company's subsidiary has received final approval for Imatinib Mesylate from Food and Drug Administration (FDA) in December 2015.
Feb 01, 2016 at 15:43 | Source: CNBC-TV18
Prabhat Awasthi, head of India equities, Nomura, says Bank of Japan's move to go into negative interest rate zone was more of a rate signal and not a liquidity tool for markets
Feb 01, 2016 at 14:15 | Source: PTI
of chronic skin disease in adult patients.The approval by the US Food and Drug Administration (USFDA) for doxycycline capsules (Zenavod) is of strength 40 mg. Zenavod is a tetracycline-class drug indicated for treatment of inflammatory lesions (papules and pustules) of rosacea in adult patients, the firm said in BSE filing today.
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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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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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