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New Delhi: Sun Pharmaceutical Industries has received a warning letter from the US drug regulator (USFDA) over violation of manufacturing norms in its facility at Halol in Gujarat on Saturday.

Inspection of the facility in September 2014 by US Food and Drug Administration (USFDA) inspectors is followed by the warning letter.


Before the September 2014 inspection, USFDA has approved the future products from the Halol facility. This might continue until all the issues are resolved.

“Sun Pharma expects to request a re-inspection by USFDA upon completion of its remediation commitments,” the company said.

It further added that it will continue to supply its product to its customers to meet its commitment towards customers and patients.

“Sun Pharma will respond to this Warning Letter with a detailed plan within the stipulated timeframe,” it said.

Sun Pharma Managing Director Dilip Shanghvi commented “While our team is working hard to ensure that the commitments made to the USFDA in September 2014 are fully completed, we will continue to cooperate with the USFDA and undertake any additional steps necessary to ensure that the US agency is completely satisfied with our remediation of the Halol facility.”

“We are pledged to being cGMP compliant and are committed to continuing to supply our customers and patients across the world with quality products that meet all specifications,” He added.

Sun Pharma responded to the USFDA inspection observations with a “robust remediation process that is still ongoing, with significant investments in automation and training to enhance its Quality Systems”.

The company was working with some external consultants to ensure remediation activities completed in an appropriate manner, it added.

Since the inspection of September 2014, the company has communicated regularly with the USFDA on the progress of its remediation and on issues of product supply.(IANS)


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