Natco Pharma's Kothur-JR Unit Receives 7 FDA Observations—Inspection Wraps Up, Compliance Under the Limelight

Natco Pharma Ltd. has informed that the US FDA inspection of its Kothur-JR manufacturing facility, conducted from June 9 through June 19, 2025, is completed. The inspection resulted in the generation of seven observations in Form 483, which is a set of areas where the company's procedures are not entirely in line with regulatory standards.

 

Although the nature of observations has not been stated by the company, it emphasized the point that it is committed to addressing all the issues at hand and will submit a complete response to the FDA within the timeframe. Kothur-JR is an important cog in Natco's formulation manufacturing chain to serve domestic as well as regulated market.

 

This comes after an independent inspection at Natco's Mekaguda API unit, which earlier reported only one procedural observation, indicating a mixed compliance record at its manufacturing presence.

 

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Source: ET Pharma – Natco FDA Observations | Business Standard – Mekaguda Plant Update