Natco Pharma shares drop over 2% after Telangana facility receives warning letter from USFDA
Upstox
2 min read • Updated: April 9, 2024, 4:31 PM
Summary
The USFDA had conducted a routine current Good Manufacturing Practices (cGMP) inspection at the company’s Kothur facility, on October 19, 2023.
Natco Pharma Ltd shares dropped more than 2% on Tuesday, April 9, after the company announced receiving a warning letter from the United States Food and Drug Administration (USFDA) for its manufacturing unit located in Kothur, Telangana.
The warning letter from the US drug regulator comes following the routine inspection conducted in October last year at the manufacturing facility located in Rangareddy district of Telangana, the company said in a filing to the stock exchanges.
Natco Pharma informed the stock exchanges that the USFDA has issued a Warning Letter to the company’s manufacturing facility of its pharma division located in Kothur.
The USFDA had conducted a routine current Good Manufacturing Practices (cGMP) inspection at the company’s Kothur facility, on October 19, 2023.
In response to the said inspection, Natco Pharma has updated the stock exchanges that the warning letter was received from the USFDA on April 8, 2024, while adding that the company does not believe that the noted letter is bound to have any impact on the company’s supplies from the Kothur facility.
Natco Pharma said that the warning letter is anticipated to not have any effect on the disruption of supplies or existing revenues from the said facility. However, it could cause a delay or withholding of pending product approvals from the Kothur site.
In response to the warning letter received from the USFDA, Natco Pharma will revert within the stipulated timelines and work closely with the US health regulator for addressing such issues in a ‘holistic and timely manner’ in order to ensure sustained compliance.
‘The Company also remains committed to being cGMP compliant and in supplying high-quality products to its customers and patients globally’, Natco Pharma said in the stock exchange filing.
Shares of Natco Pharma dropped as much as 2.2% on the NSE on Tuesday to a low of ₹978.25 per piece. However, the stock recovered some losses to close 1.6% lower at ₹983 apiece.