Jubilant Life Sciences share price fell in trade today after US health regulator issued a warning letter to the company for its Roorkee facility.
Jubilant Life Sciences share price fell 4.67% to 747.30 level compared to the previous close of 783.90 on BSE. Jubilant Life Sciences share closed 1.96% or 15 points lower at 768.50 on BSE. Jubilant Life Sciences share price has fallen 3.84% during the last one year and gained 8.29% since the beginning of this year.
The Jubilant Life Sciences share price closed above its 50-day and 200 day moving averages of 740 and 727 levels, respectively. The United States Food and Drug Administration (USFDA) may withhold approval of any new applications or supplements till the company addresses all issues raised by the agency, Jubilant Life Sciences said.
The company did not provide any details about the issues raised by the USFDA in its warning letter.
"However, we believe that the existing manufacturing and sale of products from this facility will not be impacted. US revenues from the facility is about 4 per cent of the total revenues of the company," Jubilant Life Sciences said.
The company is committed to implementing the necessary corrective actions required to address USFDA concerns and is in the process of providing a thorough and comprehensive response to the USFDA within 15 working days, it added.
Earlier on December 8, 2018, the company had said in a regulatory filing that the US health regulator had classified its inspection of the company's Roorkee solid dosage formulations facility as Official Action Indicated.
The facility was inspected by USFDA in August 2018, it added. According to the US regulator, when FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a warning letter.