India Launch Timeline
The company indicated that the Semaglutide injection is expected to be launched in the domestic market by March 2026.
Semaglutide is prescribed for adults with Type 2 diabetes to improve glycaemic control, particularly in cases where blood sugar levels remain inadequately managed through lifestyle modification alone.
The launch is expected to strengthen Natco’s presence in the chronic therapy segment, which continues to see rising demand in India.
USFDA Inspection Update
In a separate development, Natco Pharma received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration for its Active Pharmaceutical Ingredient (API) manufacturing facility located in Manali, Chennai.
The inspection had earlier resulted in seven observations under Form 483. The facility has now been classified under Voluntary Action Indicated (VAI) status, allowing operations to continue while the company undertakes corrective measures.
The VAI classification indicates that while certain improvements are required, the observations do not warrant regulatory enforcement action at this stage.
Q3 FY26 Financial Performance
For the quarter ended December 2025 (Q3 FY26), the company reported steady financial growth:
- Net Profit: ₹151.3 crore, compared with ₹132.4 crore in the corresponding quarter last year
- Revenue: ₹705.4 crore, versus ₹651.1 crore year-on-year
The performance reflects moderate expansion in both earnings and topline revenue.
Summary
Natco Pharma has received CDSCO approval to manufacture and market generic Semaglutide injections in India, with a planned launch by March 2026. The development enhances the company’s position in diabetes care. Additionally, its Chennai API facility received a VAI classification from the USFDA, allowing continued operations. In Q3 FY26, the company reported year-on-year growth in revenue and profit, indicating stable operational performance.
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