Shares of Sun Pharma surged over 3 per cent in Wednesday's trade after the pharma giant issued clarification over the USFDA warning letter that it had received for its Halol Facility.
The company clarified in a statement that no data integrity issues were raised or no reference to the quality of products was made in the warning letter. "Failed to submit revised smoke studies to demonstrate unidirectional airflow," the company said.
Reacting to the development, the scrip gained 3.38 per cent to hit a high of Rs 790.
The company said the warning letter cites a deterioration in the physical infrastructure. "Impurity levels exceeded limits in exhibit batches, which was later found to be within limits," the company said. Lack of proper analytical method validation and calibration of equipment were also cited as areas of concerns by the USFDA in the letter,
The company clarified in a statement that no data integrity issues were raised or no reference to the quality of products was made in the warning letter. "Failed to submit revised smoke studies to demonstrate unidirectional airflow," the company said.
Reacting to the development, the scrip gained 3.38 per cent to hit a high of Rs 790.
The company said the warning letter cites a deterioration in the physical infrastructure. "Impurity levels exceeded limits in exhibit batches, which was later found to be within limits," the company said. Lack of proper analytical method validation and calibration of equipment were also cited as areas of concerns by the USFDA in the letter,
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