Indoco Remedies tanked 16% to Rs 208.50, also its 52-week low on the National Stock Exchange (NSE) in early morning trade after the company said it has received a warning letter from the US health regulator for its Goa plant.
“The United States Food and Drug Administration (USFDA) had inspected the company's drug manufacturing facility in Goa from August 31, 2016 to September 4, 2016. As an outcome of this inspection, the facility received 6 observations in Form 483, which do not pertain to data integrity”, Indoco Remedies said in a filing to BSE.
Based on the review of compliance response, FDA accepted our response to 4 observations. However, FDA remains concerned with respect to 2 observations, pertaining to one specific product, for which we are contract manufacturer, for one of our customers and consequently we have received a warning letter from USFDA dated March 27, 2017, on Friday, it added.
The company said it is fully committed in resolving the issue and will respond at the earliest.
The company is also committed to its philosophy of highest quality in manufacturing, operations, systems integrity and cGMP culture. The company continues to supply products from the above mentioned facility to meet its obligations to customers and the patients in the United States of America, it added.
At 09:29 am; the stock was down 13% at Rs 216 on the NSE as compared to 0.31% rise in the Nifty 50 index. A combined 467,549 shares changed hands on the counter on NSE and BSE.
“The United States Food and Drug Administration (USFDA) had inspected the company's drug manufacturing facility in Goa from August 31, 2016 to September 4, 2016. As an outcome of this inspection, the facility received 6 observations in Form 483, which do not pertain to data integrity”, Indoco Remedies said in a filing to BSE.
Based on the review of compliance response, FDA accepted our response to 4 observations. However, FDA remains concerned with respect to 2 observations, pertaining to one specific product, for which we are contract manufacturer, for one of our customers and consequently we have received a warning letter from USFDA dated March 27, 2017, on Friday, it added.
The company said it is fully committed in resolving the issue and will respond at the earliest.
The company is also committed to its philosophy of highest quality in manufacturing, operations, systems integrity and cGMP culture. The company continues to supply products from the above mentioned facility to meet its obligations to customers and the patients in the United States of America, it added.
At 09:29 am; the stock was down 13% at Rs 216 on the NSE as compared to 0.31% rise in the Nifty 50 index. A combined 467,549 shares changed hands on the counter on NSE and BSE.
