The U.S. Food and Drug Administration (USFDA) conducted a GMP inspection of Natco Pharma Limited’s Kothur facility, located in Kothur Village, Rangareddy, Telangana 509 228, India, from June 9 to 19, 2025. The facility is already under Warning Letter.
Following the inspection, the agency issued a Form 483containing 7 observations, signalling potential quality or proceduralconcerns.
This is a key facility for Natco, as 20 ANDAs are solely manufactured in this facility including Lenalidomide. 7 ANDAs are manufactured in both the facilities (Kothur and SEZ facilities). In summary, it manufactures 27 of the 28 ANDAs representing ~98% of Natco’s total sales
One of the most important products manufactured in this facility represents ~78% of Natco’s total sales.
The chances of disruptive remediations are high given that the facility is already under Warning Letter and with 7 observations, the company might be forced to take drastic remediation measures that may likely disrupt production.
All other products (other than key products) are modest in sales with only 2 products clocking sales of more than $5 Mn annually.
19 out of total 26 products manufactured at this facility are facing competition from more than 5 generic manufacturers.
In terms of revenue impact, this facility contributes ~98%of total Natco US sales (including partnered products) and ~82% of total from products not backed by another facility.