Natco Pharma Kothur facility gets USFDA warning letter
Hyderabad: Natco Pharma has received a Warning Letter from the United States Food and Drug Administration (USFDA) for its Pharma Division located in Kothur Hyderabad, India.
In October, the Company received eight observations from the USFDA for the said facility after the inspection.
Read also: USFDA inspection: Natco Pharma gets 8 observations for Hyderabad Pharma Division
Now, according to BSE filing, Natco Pharma stated, "The Company does not believe that the Warning Letter will have an impact on disruption of supplies or existing revenues from this facility. It may cause delay/withholding of pending product approvals from this site".
"The Company will respond to the Warning Letter within the stipulated timelines and work closely with the USFDA to address the concerns in a holistic and timely manner to ensure sustained compliance," the filing noted.
"The Company also remains commited to being cGMP compliant and in supplying high-quality products to its customers and patients globally," it added.
Read also: Natco Pharma reports over 3-fold rise in net profit at Rs 212.7 crore in Q3
Natco Pharma Limited was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million. With a modest beginning of operations as a single unit with 20 employees, Natco today has eight manufacturing facilities spread across India with modern research laboratories, capabilities in New Drug Development, etc.
Read also: Natco Pharma concludes transition of DASH Pharma into Natco Pharma USA
