Rajat SharmaBisoprolol Fumarate vs Other Beta-Blocker APIs – procurement-focused comparison of Bisoprolol Fumarate against Metoprolol Tartrate, Atenolol, and Carvedilol APIs — covering identity, regulatory filings, cost, and what to check before you commit to a supplier.
📅 Updated July 2026⏱ 10 min read🏷 Pharma Procurement
Quick Answer
Bisoprolol Fumarate (CAS 104344-23-2) is a highly cardioselective beta-1 blocker prized for once-daily dosing, but it comes from a smaller, more concentrated global supplier base than Atenolol or Metoprolol Tartrate — which means slightly higher pricing and a stronger need to verify polymorphic form and DMF/CEP status before sourcing. If your formulation specifically calls for Bisoprolol’s selectivity profile, the sourcing trade-off is generally worth it; if not, Atenolol or Metoprolol may offer easier, cheaper supply.
What Is Bisoprolol Fumarate and Where It Fits in the Beta-Blocker Class
CAS Number104344-23-2Molecular Formula(C₁₈H₃₁NO₄)₂·C₄H₄O₄ (hemifumarate salt)Molecular Weight~766.97 g/mol Classification Cardioselective (β1-selective) adrenergic receptor blocker Primary Indications Hypertension, chronic heart failure
Bisoprolol Fumarate is a second-generation, highly β1-selective beta-blocker, meaning it acts more specifically on cardiac beta-1 receptors than on the beta-2 receptors found in the lungs and blood vessels. That selectivity, combined with a long plasma half-life, is why it’s commonly formulated for once-daily dosing in both hypertension and chronic heart failure management.
Most generic manufacturers don’t rely on a single beta-blocker API — they maintain a small portfolio, since different beta-blockers serve different clinical niches and formulation needs. Understanding where Bisoprolol sits relative to its most common alternatives helps you decide whether it belongs in your next filing, and which supplier risks apply specifically to it.
Overview of Competing Beta-Blocker APIs
Metoprolol Tartrate / Succinate
A widely used cardioselective beta-blocker with an exceptionally large global manufacturing base. Tartrate salt supports immediate-release formulations; succinate salt supports extended-release. High-volume generic demand keeps pricing competitive and supplier availability broad.
Atenolol
One of the longest-established cardioselective beta-blockers on the market, with an extremely mature, low-cost, high-volume supplier base, particularly across India. Simpler synthesis and long generic history make it one of the easiest beta-blocker APIs to source.
Carvedilol
A non-selective beta-blocker with additional alpha-1 blocking activity, used specifically in heart failure and post-MI management where its combined mechanism offers a therapeutic advantage. Smaller supplier base than Metoprolol or Atenolol, with more complex polymorph control requirements.
Propranolol
A non-selective beta-blocker used as a comparison point for selectivity profile discussions — relevant when a formulation calls for broader beta-receptor coverage rather than cardioselectivity. Long-established, widely available supplier base.
Bisoprolol Fumarate vs Other Beta-Blocker APIs — Side-by-Side Comparison
| API | CAS Number | Selectivity | Typical Assay Spec | Relative Sourcing Complexity |
|---|---|---|---|---|
| Bisoprolol Fumarate | 104344-23-2 | High β1-selectivity | ≥99.0% (HPLC) | Moderate–higher |
| Metoprolol Tartrate | 56392-17-7 | β1-selective | ≥99.0% (HPLC) | Lower |
| Atenolol | 29122-68-7 | β1-selective | ≥99.0% (HPLC) | Lowest |
| Carvedilol | 72956-09-3 | Non-selective + alpha-1 | ≥98.5% (HPLC) | Higher |
CAS numbers and assay specifications should always be confirmed against the individual supplier’s current COA; figures above reflect typical, publicly listed pharmacopoeial reference values.
Manufacturing and Supply Base Considerations
Atenolol and Metoprolol Tartrate benefit from the widest global manufacturing footprint, a direct result of decades of high-volume generic demand across both regulated and emerging markets. That breadth translates into more competitive pricing and shorter lead times, simply because more manufacturers are producing at scale.
Bisoprolol Fumarate supply is more concentrated among a smaller group of established manufacturers, largely in India, China, and parts of the EU. This concentration means buyers should pay closer attention to single-source dependency risk, since a disruption at one major Bisoprolol producer has a proportionally larger impact on global availability than a similar disruption would have for Atenolol.
Regulatory and Documentation Differences
DMF/CEP Availability
All four APIs discussed here have established DMF and CEP filings from multiple manufacturers, though the number of actively maintained filings is generally higher for Atenolol and Metoprolol than for Bisoprolol or Carvedilol, simply reflecting supplier base size.
Pharmacopoeial Monograph Differences
USP, EP, and BP monographs exist for all four APIs, but assay methods, related-substance limits, and identification tests can differ slightly between pharmacopoeias. Always confirm which monograph your supplier’s COA is tested against, and make sure it matches your target market’s regulatory expectations.
Impurity and Polymorphism Considerations
Bisoprolol Fumarate requires closer attention to polymorphic form and particle size distribution than some of its peers, since inconsistency at this stage can affect dissolution behavior in the finished formulation. Carvedilol carries similar polymorph-sensitivity concerns. Atenolol and Metoprolol Tartrate are comparatively more forgiving in this respect, though batch-to-batch consistency should still be verified for any API.
What to Check in the COA Regardless of API
- Assay result with test method specified (HPLC conditions, column, reference standard)
- Individual and total related substances
- Water content (Karl Fischer) and residual solvents
- Polymorphic form confirmation, where applicable (Bisoprolol, Carvedilol)
- Particle size distribution data, where relevant to your formulation
Cost and Commercial Comparison
On a relative pricing basis, Atenolol generally sits at the lowest price point, reflecting its mature, high-volume supplier base. Metoprolol Tartrate sits close behind. Bisoprolol Fumarate typically carries a modest premium, driven by its smaller supplier pool and tighter quality control requirements. Carvedilol tends to price similarly to or slightly above Bisoprolol, reflecting its more complex synthesis and polymorph control needs.
MOQ flexibility tends to track supplier base size as well — Atenolol and Metoprolol suppliers are generally more willing to accommodate smaller trial orders, while Bisoprolol and Carvedilol suppliers may set higher minimums given their more specialized production runs.
Sourcing Checklist for Beta-Blocker APIs
Beta-Blocker API Sourcing Checklist
- Confirm the exact CAS number, salt form, and polymorphic form match your formulation requirements
- Verify current DMF/CEP filing status against the relevant regulatory database
- Confirm GMP certification and recent inspection history (no unresolved 483s or import alerts)
- Request a batch-specific COA with full related-substances and particle size data
- Assess single-source dependency risk, especially for Bisoprolol and Carvedilol
- Confirm which pharmacopoeial standard (USP/EP/BP) the supplier tests against
When to Choose Bisoprolol Fumarate Over Alternatives
Bisoprolol Fumarate is the stronger choice when your formulation specifically benefits from high β1-selectivity and a once-daily dosing profile — particularly in chronic heart failure formulations where minimizing beta-2-mediated side effects (like bronchoconstriction) matters clinically.
An alternative like Atenolol or Metoprolol Tartrate may be preferable when cost and supply-chain simplicity are the priority, or when the target formulation doesn’t require Bisoprolol’s specific selectivity or half-life profile. Carvedilol becomes the better choice when a combined alpha/beta blocking mechanism is clinically indicated, such as in certain heart failure or post-MI protocols.
For generic manufacturers building a cardiovascular portfolio, stocking more than one beta-blocker API is common practice — it lets you respond to tender requirements and formulation-specific demand without being locked into a single molecule’s supply constraints.
Common Risks and Red Flags When Sourcing Beta-Blocker APIs
Watch For
Inconsistent polymorphic form across batches, or a supplier unable to confirm which polymorph they’re supplying at all.
Documentation Gaps
Suppliers lacking a valid DMF/CEP for your target market, or COAs that omit related-substances and particle-size data.
Also be alert to salt-form confusion — Bisoprolol, for instance, is sometimes offered under different salt forms depending on the manufacturer, and a mismatch between the salt form quoted and the salt form your filing specifies can cause significant regulatory delay. Always confirm the exact CAS number and salt form in writing before ordering.
Reminder: CAS numbers, assay specifications, and monograph compliance should always be verified directly against the supplier’s current, batch-specific COA before purchase. Figures in this article reflect typical, publicly listed pharmacopoeial reference values.
Frequently Asked Questions
What is the CAS number of Bisoprolol Fumarate?
Bisoprolol Fumarate is registered under CAS number 104344-23-2, with a molecular formula of (C₁₈H₃₁NO₄)₂·C₄H₄O₄ and a molecular weight of approximately 766.97 g/mol for the hemifumarate salt form used in pharmaceutical manufacturing.
Is Bisoprolol Fumarate more expensive than Metoprolol or Atenolol?
Bisoprolol Fumarate typically commands a modest price premium over Atenolol and Metoprolol Tartrate, reflecting a smaller global manufacturing base and tighter polymorph and particle-size control requirements, though exact pricing varies by supplier and order volume.
Which beta-blocker API has the widest supplier base?
Atenolol and Metoprolol Tartrate generally have the widest global supplier base due to their long generic history and high-volume demand, while Bisoprolol Fumarate and Carvedilol have a comparatively smaller, more concentrated group of established manufacturers.
Does Bisoprolol Fumarate require special polymorph control?
Yes. Bisoprolol Fumarate manufacturers should demonstrate consistent polymorphic form and particle size distribution across batches, since variation at this stage can affect dissolution behavior and formulation performance.
Can I source Bisoprolol Fumarate from both India and China?
Yes. Both countries have established Bisoprolol Fumarate manufacturers, and many formulators qualify a primary and alternate source across both regions to balance cost against documentation depth and supply continuity.
Conclusion — Choosing the Right Beta-Blocker API Source
The right beta-blocker API isn’t necessarily the cheapest or the most widely available one — it’s the one that matches your formulation’s clinical requirements. Once you’ve settled on Bisoprolol Fumarate for its selectivity and dosing profile, the sourcing decision shifts to supplier documentation depth, polymorph consistency, and supply concentration risk. Given Bisoprolol’s smaller manufacturing base compared to Atenolol or Metoprolol, qualifying both a primary and an alternate source is a reasonable precaution for any formulator building a long-term supply strategy around it.