Drug major Sun Pharmaceutical Industries today said it has received a warning letter from the USFDA over violation of manufacturing norms in its facility at Halol in Gujarat.
The warning letter follows inspection of the facility in September 2014 by US Food and Drug Administration (USFDA) inspectors.
"Post the September 2014 inspection, the USFDA has withheld future product approvals from the Halol facility. This situation may continue until all issues are resolved.
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"Sun Pharma expects to request a re-inspection by USFDA upon completion of its remediation commitments," the company said in a statement.
The firm and the Halol facility will continue to supply important drug products to meet its obligations towards the customers and the patients who use its drugs in the US and around the world, it added.
"Sun Pharma will respond to this Warning Letter with a detailed plan within the stipulated timeframe," it said.
Commenting on the development, Sun Pharma Managing Director Dilip Shanghvi said, "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."
He added: "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."
Sun Pharma said it had 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 has been working with external consultants to ensure its remediation activities have been completed in an appropriate manner, it added.
It further said since the inspection in September 2014, the company has communicated regularly with the USFDA on the progress of its remediation and on issues of product supply.
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Later in the day, addressing a conference call, Shanghvi said Sun Pharma's focus is to make the Halol plant cGMP- compliant again and rather than moving products manufactured there to other facilities.
"Major focus is on getting Halol re-certified", rather than protecting cash flow from each small products, he said.
"The issues raised in the warning letter are mainly those that were raised by observations in form 483 (by USFDA inspectors)," Shanghvi said.
The company will wait for the USFDA to put in public the warning letter, he added.
As per the USFDA, observations are made in form 483 when investigators feel that conditions or practices in the facility are such that products may become adulterated or render injurious to health.
When asked about the impact of the warning letter over the Halol plant, he said did not elaborate but said sales from the plant contributed to the total a "high single digit percentage number on consolidated basis".
He further said export from the plant to other countries will not be affected as "we remain in compliance for all the countries we are exporting to".
