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FDA released news of the ban of Emcure’s Hinjewadi manufacturing plant after it determined the plant did not meet basic quality standards.
FDA announced a ban of Emcure Pharma’s India plant following an inspection of the facility by the agency, citing poor manufacturing quality standards, according to a report from Reuters on July 14, 2016.
According to Emcure's website, although its NJ plant is "designed and maintained to prevent cross-contamination and meet cGMP requirements," the company has eight other manufacturing locations, all of which are in India. Only five of its facilities, however, are approved by FDA, according to Emcure’s website. The company manufactures both tablets and injectables at its Hinjewadi site.
In February 2015, Sagent Pharmaceuticals recalled several lots of Atracurium Besylate Injection that were manufactured by Emcure due to sterility concerns, ultimately causing Sagent to transfer the manufacture of this product to its own facilities.