NATCO Pharma Limited has secured a significant regulatory milestone with the approval from India's Central Drugs Standard Control Organisation (CDSCO) to manufacture and market generic Semaglutide injection in the domestic market. The company made this announcement on February 14, 2026, through a regulatory filing under SEBI's Listing Obligations and Disclosure Requirements.

Product Launch and Market Entry

The pharmaceutical company plans to launch the generic Semaglutide injection in the Indian market in March 2026. This timeline indicates a swift market entry strategy following the regulatory approval.

Therapeutic Application

Semaglutide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. This approval allows NATCO Pharma to enter the competitive diabetes treatment segment with a generic version of this important therapeutic agent.

Company Profile and Manufacturing Capabilities

NATCO Pharma Limited operates as a research and development-oriented, science-driven pharmaceutical company with a strong focus on oncology in targeted therapies for the domestic market. The company also concentrates on limited competition molecules in the US market.

Manufacturing and Regulatory Infrastructure

The company's manufacturing capabilities include:

• 9 manufacturing sites across India
• 2 dedicated R&D facilities
• Regulatory approvals from multiple international authorities including U.S. FDA, Brazil ANVISA, Health Canada, and WHO
• Market presence in over 50 global markets

Business Segments

NATCO Pharma's diversified portfolio encompasses multiple pharmaceutical segments:

• Generic and branded pharmaceuticals
• Specialty pharmaceuticals
• Active pharmaceutical ingredients
• Crop protection products

This CDSCO approval for Semaglutide represents another addition to NATCO Pharma's expanding pharmaceutical portfolio, particularly strengthening its position in the diabetes treatment market segment in India.

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.