Sun Pharma gets USFDA warning letter on Halol facility
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Mumbai: Sun Pharma Industries Ltd on Saturday informed stock exchanges that it has received a warning Letter from the US Food and Drug Administration (FDA) for its facility located at Halol, Gujarat.
The FDA had started inspections at the plant in September 2014.
“Sun Pharma responded to the USFDA inspection observations with a robust remediation process that is still on-going, with significant investments in automation and training to enhance its Quality Systems. Sun Pharma has been working with external consultants to ensure its remediation activities have been completed in an appropriate manner,” the company said in its statement.
The warning letter from the USFDA will add to the troubles being faced by Sun Pharma, which has also been weighed down by the integration process with Ranbaxy Laboratories.
During company’s 23rd annual general meeting held at Vadodara, Sun’s managing director Dilip Shanghvi had said that the overall growth in revenues and net profit of Sun Pharmaceuticals would be adversely impacted due to the temporary supply constraints at its Halol facility.
The FDA had started inspections at the plant in September 2014.
“Sun Pharma responded to the USFDA inspection observations with a robust remediation process that is still on-going, with significant investments in automation and training to enhance its Quality Systems. Sun Pharma has been working with external consultants to ensure its remediation activities have been completed in an appropriate manner,” the company said in its statement.
The warning letter from the USFDA will add to the troubles being faced by Sun Pharma, which has also been weighed down by the integration process with Ranbaxy Laboratories.
During company’s 23rd annual general meeting held at Vadodara, Sun’s managing director Dilip Shanghvi had said that the overall growth in revenues and net profit of Sun Pharmaceuticals would be adversely impacted due to the temporary supply constraints at its Halol facility.
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