Natco Pharma Limited has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) regarding its Active Pharmaceutical Ingredient (API) manufacturing facility in Chennai. The company disclosed this development to stock exchanges on February 13th, 2026, under SEBI listing regulations.

FDA Inspection Details

The FDA conducted an inspection at Natco Pharma's API facility located in Manali, Chennai, from November 17th to November 21st, 2025. During this inspection, the regulatory authority issued seven observations documented in Form-483.

Regulatory Classification

The FDA has classified the inspection as Voluntary Action Indicated (VAI). This classification indicates that the agency identified objectionable conditions or practices during the inspection, but the issues are not considered significant enough to warrant regulatory action at this time.

Company Response

Natco Pharma communicated this information to both the Bombay Stock Exchange (BSE) and National Stock Exchange (NSE) through a formal intimation letter. The company referenced its earlier communication dated November 21st, 2025, which likely informed exchanges about the ongoing FDA inspection.

About the Facility

The Chennai facility operates as Natco Pharma's Active Pharmaceutical Ingredient Division. The company maintains multiple manufacturing sites across India that serve various global markets and hold approvals from several international regulatory authorities including US FDA, Brazil ANVISA, Health Canada, and WHO.

Compliance Framework

This disclosure was made under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, demonstrating the company's commitment to maintaining transparency with stakeholders regarding material regulatory developments.

Natco Pharma announced its unaudited consolidated financial results for the quarter ended December 31, 2025, demonstrating steady performance with revenue growth and sustained profitability. The pharmaceutical company reported consolidated total revenue of ₹705.4 crore for Q3FY26, marking an increase from ₹651.1 crore recorded in the corresponding quarter of the previous year.

Financial Performance Highlights

The company's financial metrics for Q3FY26 showed robust operational performance across key parameters:

For the nine months ended December 31, 2025, the company reported total income of ₹35,590 million compared to ₹34,967 million in the corresponding period last year. Net profit for the nine-month period stood at ₹11,495 million against ₹14,774 million in the previous year.

Segment-wise Revenue Performance

The company's business segments showed varied performance during Q3FY26:

The pharmaceuticals segment contributed ₹6,189 million to revenue, while agro chemicals generated ₹284 million during the quarter.

Board Decisions and Corporate Actions

The Board of Directors approved several significant decisions during their meeting held on February 12, 2026:

Dividend Declaration:

• Third interim dividend of ₹1.50 per equity share (75%) for FY2025-26
• Record date: February 18, 2026
• Payment date: February 26, 2026

Key Appointments:

• Mr. Amit Parekh appointed as Chief Financial Officer effective February 13, 2026
• Mr. Kalakuntla Srinivas Rao appointed as Executive Vice President – Pharma Division
• Superannuation of Mr. S. V. V. N. Appa Rao as CFO effective February 12, 2026

Strategic Developments

The company announced plans to incorporate a wholly owned subsidiary in Chile named NATCO Pharma Chile SPA with an investment of up to US$ 3,00,000. Additionally, the Board approved the re-constitution of the Environmental, Social and Governance Committee and Risk Management Committee effective February 13, 2026.

Associate Company Performance

Natco Pharma's associate company, Adcock Ingram Holdings Limited in South Africa, contributed ₹109 million as share of profit during the quarter. The acquisition of 35.75% stake in Adcock Ingram was completed on November 11, 2025, for a total consideration of ZAR 3,873 million (USD 225 million).

Re-appointments and Governance

The Board recommended re-appointment of key directors for one-year terms effective April 1, 2026:

• Sri Venkaiah Chowdary Nannapaneni as Chairman & Managing Director
• Sri Rajeev Nannapaneni as Vice Chairman & Chief Executive Officer
• Sri Potluri Sivaramakrishna Prasad as Director and Executive Vice President
• Dr. Donthineni Linga Rao as Director & President (Technical Affairs)

These re-appointments are subject to shareholder approval through postal ballot.