Natco Pharma Share Price Dips After USFDA Flags 7 Observations in Kothur Facility Inspection

Market Performance: Natco Pharma Share Price Dips After USFDA Observations

Natco Pharma's share price opened lower on June 20 after receiving regulatory scrutiny.

• Opening Price: ₹870.45
• Decline: ₹10.90 or 1.24% down on BSE
• Market Cap: ₹15,590.62 Crore

Currently, Natco Pharma's share price is:

• 46.21% below its 52-week high of ₹1,638.35 (as on September 12, 2024)
• 33.53% above its 52-week low of ₹660.05 (as of April 7, 2025)

Main News: Seven Observations from USFDA Trigger Slide

Natco Pharma informed the exchanges that the US Food and Drug Administration (USFDA) concluded an inspection at its pharma division in Kothur, Hyderabad, which took place between June 9 and June 19, 2025.

Following the inspection, the company received seven observations in Form-483.

Natco Pharma stated its intention to resolve all points within the stipulated timeline.

Earlier, on June 13, another inspection was concluded at the company's API manufacturing facility in Mekaguda, Hyderabad. That audit led to one observation in the Form 483.

Company Details: Natco Pharma's Global Commitment

Despite the observations, Natco Pharma reiterated its commitment to:

• Adhering to current Good Manufacturing Practices (cGMP)
• Ensuring high-quality products for global markets
• Maintaining regulatory compliance across facilities

Summary of the Article

The Natco Pharma share price slipped by over 1% in early trading on June 20, following seven Form-483 observations from the US Food and Drug Administration (USFDA) after an inspection at its Kothur facility.

A separate facility at Mekaguda had earlier received one observation.

Despite the decline, Natco Pharma assured stakeholders of its readiness to comply and its commitment to addressing regulatory issues efficiently.