NATCO Pharma Receives CDSCO Approval for Generic Semaglutide Injection in India

1 min read     Updated on 14 Feb 2026, 08:26 PM
scanx
Reviewed by
Radhika SScanX News Team
Overview

NATCO Pharma Limited received CDSCO approval on February 14, 2026, to manufacture and market generic Semaglutide injection in India, with commercial launch planned for March 2026. The diabetes treatment product is indicated for adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. This regulatory milestone strengthens NATCO's pharmaceutical portfolio in the domestic market.

32626570

*this image is generated using AI for illustrative purposes only.

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.

Parameter: Details
Product: Generic Semaglutide Injection
Regulatory Authority: CDSCO (Central Drugs Standard Control Organisation)
Approval Date: February 14, 2026
Planned Launch: March 2026
Market: India

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.

Historical Stock Returns for Natco Pharma

1 Day5 Days1 Month6 Months1 Year5 Years
-5.94%-4.49%+13.81%+10.86%+21.94%+15.85%

Natco Pharma Reports Q3FY26 Results with ₹705.4 Crore Revenue and ₹151.3 Crore Net Profit

2 min read     Updated on 13 Feb 2026, 04:55 PM
scanx
Reviewed by
Jubin VScanX News Team
Overview

Natco Pharma delivered robust Q3FY26 results with consolidated revenue of ₹705.4 crore and net profit of ₹151.3 crore, demonstrating strong growth across key financial metrics. The company declared its third interim dividend of ₹1.50 per share and announced significant leadership changes including the appointment of a new CFO, while maintaining compliance with regulatory publication requirements.

32454813

*this image is generated using AI for illustrative purposes only.

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:

Metric: Q3FY26 Q3FY25 Change
Total Income: ₹7,054 million ₹6,511 million +8.3%
Revenue from Operations: ₹6,473 million ₹4,748 million +36.3%
Net Profit: ₹1,513 million ₹1,324 million +14.3%
EBITDA Margin: 30.7% - -
Basic EPS: ₹8.46 ₹7.43 +13.9%

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:

Business Segment: Q3FY26 (₹ Crore) Q2FY26 (₹ Crore) Q3FY25 (₹ Crore)
Active Pharmaceutical Ingredients: 64.3 53.9 66.6
Domestic Formulations: 119.8 105.4 96.1
Formulations Export: 421.4 1,147.0 285.8
Crop Health Sciences: 28.5 52.4 15.1
Other Income: 71.3 104.3 187.5

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

Regulatory Compliance and Publications

Pursuant to Regulation 47 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, the company published its quarterly results in leading newspapers on February 13, 2026. The publications appeared in Business Line, Financial Express, and Nava Telangana, providing comprehensive disclosure of the unaudited financial results and dividend notice.

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.

Historical Stock Returns for Natco Pharma

1 Day5 Days1 Month6 Months1 Year5 Years
-5.94%-4.49%+13.81%+10.86%+21.94%+15.85%

More News on Natco Pharma

1 Year Returns:+21.94%