Sun Pharmaceutical Industries has dipped 2% to Rs 615 on the BSE, its lowest level since November 9, 2016.
In past 14 trading days, the stock of pharma company was down 15% erasing its entire gain recorded post July-September (Q2FY17) results. The S&P BSE Sensex was down 0.76% during the same period.
Between November 9 and December 1, post Q2F17 results, the stock had outperformed the market by gaining 9% from Rs 661 to Rs 722, as compared to 2.5% decline in the benchmark index.
On December 7, Sun Pharma said that the US health regulator made nine observations after the completion of inspection of its Halol facility in Gujarat.
The United States Food and Drug Administration (US FDA) inspected the Halol facility from November 17, 2016 to December 1, 2016.
"At the conclusion of the inspection, the US FDA issued a Form-483, citing nine inspectional observations. None of those observations were characterised by the US FDA as repeat observations," it added.
The company is preparing responses to the observations, which will be submitted to US FDA within 15 business days of receipt of the Form-483, Sun Pharma said.
Halol plant is key for Sun Pharma and it contributed in high single digits to its US sales before it was issued a warning letter last December.
According to Business Standard reports, Credit Suisse has cut Sun Pharma's FY 2018 profit estimate by 5% to Rs 7,484 crore to factor the delay in resolution of issues at Halol while Religare Institutional Research said that every month's delay in issue resolution can have an adverse impact of 0.7-0.8% on the next fiscal's profit estimate. CLICK HERE TO READ FULL REPORT.
In past 14 trading days, the stock of pharma company was down 15% erasing its entire gain recorded post July-September (Q2FY17) results. The S&P BSE Sensex was down 0.76% during the same period.
Between November 9 and December 1, post Q2F17 results, the stock had outperformed the market by gaining 9% from Rs 661 to Rs 722, as compared to 2.5% decline in the benchmark index.
On December 7, Sun Pharma said that the US health regulator made nine observations after the completion of inspection of its Halol facility in Gujarat.
The United States Food and Drug Administration (US FDA) inspected the Halol facility from November 17, 2016 to December 1, 2016.
"At the conclusion of the inspection, the US FDA issued a Form-483, citing nine inspectional observations. None of those observations were characterised by the US FDA as repeat observations," it added.
The company is preparing responses to the observations, which will be submitted to US FDA within 15 business days of receipt of the Form-483, Sun Pharma said.
Halol plant is key for Sun Pharma and it contributed in high single digits to its US sales before it was issued a warning letter last December.
According to Business Standard reports, Credit Suisse has cut Sun Pharma's FY 2018 profit estimate by 5% to Rs 7,484 crore to factor the delay in resolution of issues at Halol while Religare Institutional Research said that every month's delay in issue resolution can have an adverse impact of 0.7-0.8% on the next fiscal's profit estimate. CLICK HERE TO READ FULL REPORT.