Medicamen Biotech Gets US FDA Approval For Bortezomib Injection; Stock Price Up By More Than 3%
By Ankur Chandra | Published at: Jun 3, 2025 03:20 PM IST
New Delhi, June 3, 2025 — Medicamen Biotech Ltd (NSE: MEDICAMEQ | BSE: 531146) has received its first-ever Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (USFDA) for Bortezomib for Injection, 3.5 mg, marking a strategic inflection point as the company positions itself for entry into the U.S. generics market.
Breakthrough Approval: Gateway to Regulated Markets
The approved drug, Bortezomib for Injection (3.5 mg Single-Dose Vial), is deemed bioequivalent and therapeutically equivalent to Takeda’s reference listed drug Velcade (NDA-021602). This positions Medicamen as a viable contender in the oncology injectable segment, specifically in multiple myeloma and mantle cell lymphoma treatments.
Medicamen’s API for Bortezomib was developed in-house and manufactured at its partner facility, Shivalik Rasayan, which holds a USDMF (036171). The achievement is a reflection of its strong R&D capabilities and vertically integrated manufacturing platform, coupled with compliance to cGMP standards.
In an official exchange filing, the company stated “This is a significant milestone for Medicamen’s journey into regulated markets, and a testament to our quality systems and regulatory commitment.”
Stock Reaction and Market Snapshot
Following the announcement, as of 12:57 p.m. IST, June 3, 2025, the company’s shares hiked 2.95% to ₹430.60, a clear reflection of investor optimism.
Key Stock Metrics (as of June 3, 2025)
| Metric | Value |
|---|---|
| Last Traded Price | ₹430.60 |
| Previous Close | ₹418.25 |
| 52-Week High | ₹630.00 (Dec 2024) |
| 52-Week Low | ₹375.05 (Aug 2024) |
| Market Cap | ₹584.01 crore |
| PE Ratio (TTM) | 87.43 |
| Deliverable to Trade Ratio | 71.91% |
| Daily Volatility | 3.40% |
Financial Snapshot (FY25)
Medicamen reported resilient numbers for FY25, maintaining profitability amid ongoing investments in R&D and compliance.
| Parameter | Standalone (₹ lakh) | Consolidated (₹ lakh) |
|---|---|---|
| Total Income | 3,121.49 | 3,484.02 |
| Profit Before Tax (PBT) | 303.64 | 249.02 |
| Net Profit | 240.98 | 186.36 |
| Earnings Per Share (EPS) | ₹1.90 | ₹1.47 |
Shareholding Trends
As of April 24, 2025, promoter holding stood at 40.46%, with the public holding at 59.54%. This indicates consistent public investor interest despite a slight decline in promoter stake from 43.16% in March 2025.
Strategic Outlook
This USFDA approval hits the dual goal for the company by strengthening its regulatory credibility and unlocking a significant revenue stream from one of the world’s largest pharmaceutical markets. Moving forward, the company is expected to reinforce its strategy by making more filings from its R&D pipeline and become a global generics player.
With a robust foundation, vertically integrated model, and validated regulatory track record, Medicamen Biotech is now poised to scale newer heights in the global pharmaceutical landscape.
REF: https://nsearchives.nseindia.com/corporate/MEDICAMEQ_03062025125621_Announcement03062025.pdf
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