Emcure Pharmaceuticals faces ban from USFDA for Maharashtra plant
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US FDA bans Emcure Pharmaceuticals' Maharashtra plant over manufacturing issues
Indian pharmaceuticals industry is the largest supplier of medicines to the US, outside US, and in the past, also, has faced subjective issues over quality of manufacturing drugs
Indian pharmaceutical companies continue to disappoint the USFDA over manufacturing quality issues of cheap generic drugs. India has a strong foothold in the US market, yet, has been drawing flak from the US authorities over its shoddy manufacturing standard. As a result, companies like Sun Pharmaceuticals, Ipca Labortaries, Cadilla Pharmaceuticals, Wockhardt, and now Emcure Pharmaceutical's Maharashtra manufacturing plant, continue to come under the scanner of stringent quality standards imposed by FDA.
In an 'import alert' posted on its website earlier this week, the FDA said it had barred imports from Emcure's Hinjewadi manufacturing plant in the western state of Maharashtra, after an inspection revealed the company was not meeting manufacturing quality standards (source Reuters).
According to some earlier reports in the media, India is a key market for supplying medicines to the US market (constitutes almost 40% market share, outside the US market- as per figures shared in 2014). As a consequence, India’s supply of affordable generic drugs to the US continues to be in the news for its quality standards.
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