FDA warns Indian origin Drugmaker,Emcure Pharmaceuticals
Indian Drugmaker Emcure Pharmaceuticals was recently warned by U.S. Food and Drug Administration (FDA) for fudging test records and violating standard manufacturing practices in its Hinjwadi plant located in Pune.
The company determined to improve operations in its plant in 2014 has remained clearly ineffective in action, said FDA. In its 2015 inspection the FDA said it found continuing practices of data falsification.
FDA has already banned 42 companies from importing their pharmaceuticals in U.S.A.
Emcure Pharmaceuticals headquartered at Pune in West India is an Indian pharmaceutical company operating eight plants in India, supplies medicines to the United States, Europe, Brazil and Japan, according to its website.
FDA has granted 15 days to Emcure to look into the concerned matter and release corrective orders.