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Corporate - Regulatory Bodies & Rulings
USFDA nod for Strides facility

Bangalore, Oct. 9

Strides Arcolab’s oral dosage form facility in Bangalore has received a renewed approval from the USFDA, the company has announced. “The manufacturing site at KRS Gardens in Bangalore has been classified as acceptable by the USFDA for manufacturing oral products for the US market,” it said. Mr Venkat lyer, CEO – India Operations of Strides, said the plant was already approved in 2005 and the return approval would support currently approved filings a nd the additional product submissions that would come out of the facility. Four of the filings made for the US market are for oral products. “The continued USFDA approval of the facility is an important milestone for the company’s US strategy,” he said. The facility manufactures coated tablets and hard gelatine capsules and also meets some of the export requirements for Europe and South Africa. —

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