Lupin Painkillers Get FDA Green Signal - Details

Lupin painkillers have got approval from the US Food and Drug Administration. The company has announced that Gavis Pharmaceuticals LLC, its US subsidiary, has got the green signal for Hydrocodone Bitartrate and Acetaminophen painkillers. According to Lupin, these tablets are the AA-rated equivalent of Mikart, Inc's tablets. Gavis is a leading company in the formulation, development, manufacturing, packaging, sales, marketing and distribution of pharmaceuticals.

Lupin is a transnational pharmaceutical company which develops and delivers a wide range of branded and generic formulation, APIs and biotechnology products all over the world. The company has a major stake in the fields of asthma, cardiovascular, GI, CNS, anti-infective and pediatric medicines. It is also a global leader in anti-TB medicines.

For the 2015-2016 financial year, Lupin's consolidated sale was $2.09 billion and net profit $345 million. Its registered office is in Mumbai, India. Hydrocodone Bitartrate and Acetaminophen tablets had a sale of $89.6 million in the United States, according to IMS MAT September 2016 data.

Lupin happens to be the fifth largest pharmaceutical player in the US by prescription. It is the third largest pharmaceutical company in India by revenues. It stands as the sixth largest company in Japan and fourth largest in South Africa.

Lupin painkiller can be used for moderate to moderate-severe pain. The company has received FDA approval for 198 products. Lupin presently stands at 339 with the FDA. The announcement of the FDA approval came through a press release. Company Secretary R.V. Satam issues the statement on behalf of Lupin.

The FDA earlier approved a painkiller OxyContin which combines Oxycodone and Naloxone. According to the FDA, the medicine is quite hard to abuse. But, experts believe it can be easily abused. They believe the drug can be snorted in powder form or injected to use its complete narcotic payload immediately. When crushed, the naxolone gets active, the LA Times reported.

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