Natco Pharma Concludes US FDA Inspection at Andhra Pradesh FDF Unit

Natco Pharma Concludes US FDA Inspection at Andhra Pradesh FDF Unit​

Natco Pharma Limited (BSE: 524816; NSE: NATCOPHARM) has announced the conclusion of a U.S. Food and Drug Administration (FDA) inspection conducted at its Finished Dosage Formulations (FDF) unit located in Visakhapatnam, Andhra Pradesh, India.

The FDA inspection took place from August 17 to August 21, 2026, focusing on the company's FDF manufacturing plant in Parawada, Visakhapatnam.

Following the conclusion of the review, Natco Pharma received a Form 483 detailing the observations. The document contained four specific observations.

The Company stated that it believes these findings are procedural in nature and expressed confidence in comprehensively addressing all observations within the stipulated timelines.

Company Overview and Global Approvals​

NATCO Pharma Limited is a company headquartered in Hyderabad, specializing in the development, manufacturing, and distribution of generic and branded pharmaceuticals, specialty pharmaceuticals, active pharma ingredients, and crop protection products.

The company operates as an R&D oriented and science driven player focused on targeted therapies for the domestic market and limited competition molecules in the US.

NATCO Pharma's manufacturing facilities hold approvals from several major global regulatory authorities, including the U.S. FDA, Brazil ANVISA, Health Canada, and WHO. These facilities cater to over 50 international markets.

NATCOPHARM Stock Price Movement​

On Friday, Natco Pharma Limited edged higher in the market, closing at ₹882.4 after gaining ₹5.10, or 0.58%, from its previous close. The stock saw active participation throughout the session, with a traded volume reaching 363,713 shares.