USFDA

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture Abacavir Sulfate and Lamivudine tablets, 600 mg/300 mg. Aurobindo’s Abacavir Sulfate and Lamivudine tablets are the AB rated generic equivalent of VIIV Healthcare Company’s Epzicom tablets.

Timely action has stopped at least 1000kilos of fake cosmetics from coming on the market at a time when the demand for sunscreens are enormous. A Girgaum man has been prosecuted by the state Food and Drug Administration (FDA) for trying to sell spurious sunscreen tubes, filled with baby lotion, under the brand name of a reputed international cosmetics company.

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“Sun Pharma” and includes its subsidiaries or associate companies) was informed by the US FDA , that it will lift the Import Alert imposed on the Mohali (Punjab) manufacturing facility and remove the facility from the Official Action Initiated (OAI) status. This proposed action will clear the path for Sun Pharma to supply approved products from the Mohali facility to the US market, subject to normal US FDA regulatory requirements.

The explosive growth of the Indian pharmaceutical industry over the last decade has made the nation the host of most FDA-approved plants outside the United States.
Leaders of two of India's largest drug manufacturers said the integration of electronic systems to avoid quality failures in factories is proceeding more slowly than expected, as industry intends to adapt to Enhanced regulatory oversight in developed countries.

Aurobindo Pharma USA Inc. recalls 47,040 bottles of Venlafaxine hydrochloride prolonged-release capsules in the 37.5 mg strength in a national recall in the US, the latest USFDA enforcement report said. The drug was manufactured by Aurobindo Pharma Ltd, Hyderabad

The United States Food and Drug Administration (US FDA) issued a warning letter to Bangalore-based resonance laboratories for filthy manufacturing practices and gave 15 days of time for the company to shape up or ship out.

The prospect of a major change to the regulatory agency comes as drug makers are under fire for high prices, including Marathon Pharmaceuticals LLC, which said  "stop" the launch of its drug Duchenne muscular dystrophy after American lawmakers questioned her $ 89,000 a year award.

President Trump promised to review the Food and Drug Administration could make major changes, including steps to accelerate the approval process of new prescription drugs, setting up a shock with critics who say its push for the Deregulation could put consumers at risk.

uniQure N.V. announced that AMT-060,  its proprietary, investigational gene therapy in patients with severe hemophilia B, has received Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA).  This designation is based on results from the ongoing, dose-ranging Phase 1-2 study that show sustained increases in Factor IX (FIX), reductions in FIX replacement usage and a near cessation of spontaneous bleeding in patients with severe disease at up to 12 months follow-up. 

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