Aurobindo Pharma gets FDA nod for two...
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Jun
23
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Aurobindo Pharma gets FDA nod for two generic drugs
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AUROBINDO Pharma, Hyderabad headquartered manufacturer of generic pharmaceuticals and active pharmaceutical ingredients, has said that it has received two final approvals from the US food & drug administration (USFDA)

According to the company, it received the approval from the USFDA to manufacture and market Entacapone tablets 200mg and the product will be launched soon. The tablets are generic versions of Orion Corporation’s Comtan, used in the treatment of Parkinson’s disease. As per IMS, the drug has an estimated market size of $59 million for the 12 months ending April 2015. This is the 39th ANDA to be approved out of its Unit VII formulation facility in Hyderabad for manufacturing Oral Non-betalactam products. It also got approval to manufacture and market Azithromycin for injection USP, in a strength of 500mg /vial. The antibacterial drug is equivalent to Zithromax of Pfizer. The drug is indicated for treatment of infections such as community-acquired pneumonia and pelvic inflammatory disease.

Aurobindo now has 12 ANDAs approved out of its Unit IV formulation facility in Hyderabad for manufacturing general injectable products. It will marketed and sold by Aurobindo’s wholly owned subsidiary AuroMedics Pharma LLC.

The company’s product portfolio is spread over six major therapeutic/product areas encompassing antibiotics, anti-retrovirals, CVS, CNS, gastroenterologicals and anti-allergics.



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