Another step towards strengthening its complex generics portfolio, Biocon Pharma, a subsidiary of Biocon Limited, has received USFDA approval for its ANDA for Norepinephrine Bitartrate Injection USP, 4 mg/4 mL (1 mg/mL) single-dose vial.
Norepinephrine bitartrate injection is a critical medicine to raise blood pressure in adult patients with acute hypotension. Acute hypotension is a sudden and drastic drop in blood pressure which often requires immediate medical attention to restore hemodynamic stability. In its filing with BSE and NSE, the company stated that this approval adds another complex injectable formulation to Biocon’s global portfolio, showcasing its ability to deliver high-quality complex drug products in highly regulated markets.
Market Response: Biocon Pharma Shares Up
The market reacted positively to this development. Biocon shares jumped 1.97% intraday on 24 March 2025 to a high of INR 351.8 on NSE. The stock closed at INR 349.50, up 3.47% from the day’s low of INR 340.20.
Biocon Pharma has given nearly 35% returns to shareholders over the past one year. However it has corrected 5% so far this year. The company’s market capitalization is at INR 42,009 crore on NSE. The stock has seen 52 week high of INR 404.70 and 52 week low of INR 247.55.
The broader market was also positive with BSE Sensex up 1.39% (1,068 points) at 77,973 and NSE Nifty 50 up 1.44% (335 points) at 23,686.
Biocon’s Diversified Global Presence and Future Pipeline
Founded by entrepreneur Kiran Mazumdar-Shaw, Biocon Limited has evolved into a global biopharmaceutical company with four business verticals:
- Generics
- Biosimilars* Novel Biologics
- Research Services
Biocon Biologics has made a big stride in international markets with 8 biosimilar products commercialized in the US, Europe, Australia, Canada and Japan. Biocon Biologics has a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, ophthalmology and other non-communicable diseases.
Recently Biocon announced positive results from a Phase 3, randomized, double-blind, multicenter study comparing its biosimilar YESINTEK (biosimilar to Ustekinumab) with the reference product Stelara in adult patients with moderate to severe chronic plaque psoriasis (PsO). Another proof of Biocon’s science and ability to deliver high-quality biosimilars that meet regulatory standards.
Conclusion: Biocon Keeps the Momentum Going
As Biocon expands in regulated markets and delivers complex, high-impact pharmaceuticals, the company is poised for growth. USFDA approval for Norepinephrine Bitartrate Injection is not just a regulatory approval but a reflection of Biocon’s commitment to science and patient care globally.
Investors and stakeholders will be watching as Biocon moves on multiple fronts — new product launches, regulatory approvals and clinical pipeline — all pointing towards a bright future for the pharma major.