Natco Pharma's Hyderabad facility passes USFDA Pre-Approval inspection

Natco Pharma in a regulatory filing after market hours on Friday, 6 March 2020 announced the company completed Pre-Approval inspection from the United States Food and Drug Administration (USFDA) with one observation.

The inspection was carried out at company's formulation facility in Kothur Village, near Hyderabad from 2 March to 6 March 2020. The company said it received single observation related to equipment qualification of a co-mill used in the process that had operating speed slightly outside the qualification range.

The company clarified that this is a minor observation and can be addressed within a short period of time. Furthermore, the company assured it will provide a corrective action plan within the next 15 working days to address the observation.

 

Shares of Natco Pharma were trading 0.15% higher at Rs 601.75. The stock has declined 14.43% in one month as compared to a 4.59% fall in Nifty Pharma index.

Natco Pharma is engaged in developing, manufacturing and marketing finished dosage formulations (FDF) and active pharmaceutical ingredients (APIs).

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