Sun Pharma gets USFDA warning letter on Halol facility
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.
Sun Pharma’s drug launches in the US have already been affected due to the scrutiny at the Halol plant.
“No new FDA approvals from Halol to be made till re-inspection is completed by the FDA, the timing of which remains uncertain. Regulatory risk from Halol remains the biggest imponderable,” said a November report from Emkay Global Financial Services Ltd.
Sun Pharma had also issued a profit warning in July.
Shanghvi said that the company will continue to cooperate with the USFDA and undertake any additional steps necessary to ensure that the US agency is completely satisfied with the remediation of the Halol facility.
“Sun Pharma has always ensured that its products are safe and effective and there is no doubt on the safety of our products in the market,” he said.
Sun Pharma and the Halol facility will continue to supply important drug products to meet its obligations to its customers and the patients who use its drugs in the US and around the world, the company said in its statement.
On account of lower sales and supply constraints, Sun Pharmaceuticals had reported a 46% dip in its consolidated net profit ofRs.1,106.66 crore for the second quarter ended 30 September.
About 50% of Sun Pharma’s annual sales comes from the US, 24% from India, 14% from emerging markets and around 12% from the rest of the world and other businesses.
According to Shanghvi, charges arising out of the Ranbaxy integration as well as remedial actions, will result in decline of profit in coming quarters.
After its merger with Ranbaxy Laboratories at an enterprise value of $4 billion in March, Sun Pharma has been consolidating its position in the US. Following the merger, Sun Pharma became the world’s fifth-largest specialty generic pharmaceuticals company. About 50% of its annual sales is in the US, 24% in India, 14% in emerging markets and around 12% in the rest of the world and other businesses.
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.
Sun Pharma’s drug launches in the US have already been affected due to the scrutiny at the Halol plant.
“No new FDA approvals from Halol to be made till re-inspection is completed by the FDA, the timing of which remains uncertain. Regulatory risk from Halol remains the biggest imponderable,” said a November report from Emkay Global Financial Services Ltd.
Sun Pharma had also issued a profit warning in July.
Shanghvi said that the company will continue to cooperate with the USFDA and undertake any additional steps necessary to ensure that the US agency is completely satisfied with the remediation of the Halol facility.
“Sun Pharma has always ensured that its products are safe and effective and there is no doubt on the safety of our products in the market,” he said.
Sun Pharma and the Halol facility will continue to supply important drug products to meet its obligations to its customers and the patients who use its drugs in the US and around the world, the company said in its statement.
On account of lower sales and supply constraints, Sun Pharmaceuticals had reported a 46% dip in its consolidated net profit ofRs.1,106.66 crore for the second quarter ended 30 September.
About 50% of Sun Pharma’s annual sales comes from the US, 24% from India, 14% from emerging markets and around 12% from the rest of the world and other businesses.
According to Shanghvi, charges arising out of the Ranbaxy integration as well as remedial actions, will result in decline of profit in coming quarters.
After its merger with Ranbaxy Laboratories at an enterprise value of $4 billion in March, Sun Pharma has been consolidating its position in the US. Following the merger, Sun Pharma became the world’s fifth-largest specialty generic pharmaceuticals company. About 50% of its annual sales is in the US, 24% in India, 14% in emerging markets and around 12% in the rest of the world and other businesses.
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