Biocon Ltd. (NSE:BION) has secured another regulatory milestone as its subsidiary, Biocon Pharma, received approval from the United States Food and Drug Administration (USFDA) for its norepinephrine bitartrate injection. This critical medication is used to treat acute hypotension in adult patients, marking a significant expansion in Biocon Pharma’s complex injectables portfolio.
The approval covers the norepinephrine bitartrate injection 4 mg/4 mL (1 mg/mL) single-dose vial, which can now be commercialized in the lucrative US market. Biocon made the announcement through a stock exchange filing on Monday, March 24, reinforcing its commitment to strengthening its global pharmaceutical footprint.
A Series of USFDA Approvals Boosting Biocon’s Portfolio
This latest nod follows a series of approvals granted by the USFDA earlier this month. On March 4, Biocon Pharma received final approvals for two key drug products:
- Lenalidomide Capsules (2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg), used for treating multiple myeloma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, and anemia in myelodysplastic syndromes (MDS).
- Dasatinib Tablets (20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg), indicated for Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) in adults and children aged one year and above.
Additionally, Biocon received tentative approval for Rivaroxaban Tablets USP (2.5 mg, 10 mg, 15 mg, and 20 mg), which are used for deep vein thrombosis (DVT) treatment, pulmonary embolism management, and reducing stroke risk in nonvalvular atrial fibrillation.
Valuation Insights—Is Biocon a Buy?
For investors looking to assess Biocon’s potential, the company’s fair value can provide crucial guidance. According to InvestingPro’s Fair Value tool, Biocon’s intrinsic value stands at INR 366.4 per share, indicating a 4.5% upside potential from its current market price (CMP) of INR 350.6.
Image Source: InvestingPro
InvestingPro’s fair value assessment leverages multiple financial models to derive precise stock valuations, helping investors make informed decisions about potential overvaluation or undervaluation. With Biocon securing key regulatory approvals and expanding its US portfolio, the fair value tool provides a data-backed perspective on whether the stock is poised for further gains.
Unlock Exclusive Investment Insights
InvestingPro is an essential tool for investors looking to navigate stock markets with confidence. With features such as AI-powered analysis, pre-built stock screeners, and real-time fair value estimates, InvestingPro simplifies complex market evaluations.
Right now, InvestingPro is offering discounts of up to 45%, making it the perfect time to subscribe and gain access to premium stock analysis tools. Don’t miss out—subscribe today and elevate your investing strategy!
Read More: Confused Between Pro/Pro+? Here’s How to Find Great Stocks With
X (formerly, Twitter) - Aayush Khanna
LinkedIn - Aayush Khanna