Suppliers and packagers for angiomax

angiomax

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sandoz	ANGIOMAX	bivalirudin	INJECTABLE;INTRAVENOUS	020873	NDA AUTHORIZED GENERIC	Civica, Inc.	72572-035-10	10 VIAL, SINGLE-USE in 1 CARTON (72572-035-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (72572-035-01)	2020-12-21

A N I O M A X: Suppliers, manufacturing chain, and IP-facing supply risks

Last updated: May 27, 2026

Executive summary

• A N G I O M A X (bivalirudin) supply is concentrated among a small number of branded API/formulation manufacturers, with Baxter historically acting as the key commercial source for the U.S. market.
• The key supplier risk for continuity is not “multiple drug sources” but single-site or limited-site sterile/lyophilized liquid-bulk finishing and raw-material constraints tied to a specialized peptide manufacturing chain.
• For IP and entry risk workstreams, A N G I O M A X should be treated as highly mature with an already-established generic/bivalirudin landscape, so supplier availability is the primary operational lever for new launches and contract manufacturing decisions, not patent-controlled process novelty.

Who supplies A N G I O M A X (bivalirudin) in the U.S. and what are the supply-chain roles?

Short answer: The U.S. branded channel for A N G I O M A X is associated with Baxter as the commercial manufacturer/distributor, while the underlying supply chain typically splits into API peptide manufacture, intermediate peptide handling, and final sterile drug product manufacturing and fill-finish.

API and peptide manufacturing: what “supplier” means for bivalirudin

Bivalirudin is a synthetic peptide. For procurement, “supplier” usually maps to:

1. API manufacturer: produces the bivalirudin peptide under cGMP.
2. Drug-product manufacturer: formulates, fills, and completes sterile presentation (depending on the dosage form).
3. Packaging and labeling vendor: secondary packaging and serialization.

Fill-finish and sterile handling: where continuity breaks

The highest operational fragility is usually:

• Lyophilized bulk finishing or aseptic preparation steps (depending on the marketed presentation).
• QC release testing capacity for peptide identity, purity, and activity assays.
• Stability drift management for peptide formulations.

What companies manufacture bivalirudin and sell A N G I O M A X worldwide?

Short answer: Branded A N G I O M A X sourcing has historically been tied to Baxter in major regulated markets, while API and generics are handled by additional specialized suppliers in Europe, India, and China through contract manufacturing and licensed production arrangements.

How to treat “global suppliers” for bivalirudin procurement

For business planning, split the supplier list into two buckets:

• Brand channel sources (branded drug product supply to wholesalers/hospitals)
• Generic channel sources (ANDA drug product and/or API suppliers feeding multiple marketers)

Common supplier categories in bivalirudin chains

• Sterile injectables CDMOs with peptide competence
• Peptide API plants with validated solid-phase or equivalent peptide synthesis capability
• Regional finished-goods distributors for hospital tender compliance

Which generic bivalirudin suppliers are active, and how does that affect A N G I O M A X sourcing?

Short answer: The presence of generic bivalirudin materially reduces long-term supply fragility for clinicians, but it can also cause tender-driven price volatility for wholesalers competing against branded supply.

What “generic supplier activity” changes operationally

• Shortens lead times during branded disruptions
• Increases substitution risk for procurement teams
• Shifts inventory strategies from single-source contingency to multi-supplier tendering

What formulation and dosage suppliers matter for A N G I O M A X procurement?

Short answer: Procurement hinges on matching:

• Dosage form (injectable presentation used in cardiac and PCI workflows)
• Concentration and pack size
• Labeling and hospital kit compatibility
• NDC-specific presentation

Dosage form matching risk

Even when the API is the same (bivalirudin), procurement failures happen when suppliers deliver:

• The wrong concentration
• The wrong fill volume per vial
• A presentation mismatch that prevents automated preparation or kit substitution

How does FDA listing translate into identifying A N G I O M A X suppliers?

Short answer: For U.S. supplier mapping, the most direct operational method is to use:

• FDA Orange Book listings (drug product entries)
• FDA NDC Directory for labeling and manufacturer/distributor data
• FDA CDER facility databases to tie listings to manufacturing sites

Orange Book status implications

For A N G I O M A X, a mature product typically means:

• Limited remaining patent-driven exclusivity constraints
• Broader supplier availability via ANDA entries
• Faster substitution by procurement teams

What are the main supply constraints and lead-time drivers for bivalirudin peptides?

Short answer: Lead-time drivers are concentrated in API peptide synthesis, sterile finishing capacity, and batch release testing bandwidth.

Capacity constraints to monitor

• Peptide synthesis throughput and key reagent availability
• Purification column and chromatography media lead times
• Sterile fill-finish capacity and aseptic line downtime
• Release assay method capacity (HPLC/LC-MS and peptide-specific identity/purity)

Supplier diversification strategy for A N G I O M A X (bivalirudin) continuity planning

Short answer: Diversify across (1) finished drug product suppliers and (2) API/contract partners that can support surge production, while maintaining NDC-level compatibility for hospital formularies.

Practical diversification model

• Tier 1: branded-equivalent finished-goods supplier(s)
• Tier 2: generic fill-finish suppliers
• Tier 3: API suppliers that can support more than one drug-product site

Key Takeaways

• A N G I O M A X supply is historically anchored by Baxter in the branded U.S. channel, with bivalirudin’s peptide-based manufacturing chain concentrated among specialized API and sterile drug-product suppliers.
• Procurement continuity risk is driven more by manufacturing site capacity and sterile finishing constraints than by API “shortage” in the generic era.
• For operational readiness, supplier identification should be done at the level of NDC/presentation matching and supported by Orange Book and FDA NDC/facility records.

FAQs

1. Which FDA listings identify the manufacturer for A N G I O M A X NDCs?
2. How can hospitals verify that a generic bivalirudin supplier matches A N G I O M A X dosing/vial presentation?
3. What bottlenecks most often trigger bivalirudin supply disruptions: API synthesis or sterile fill-finish?
4. Do bivalirudin generics reduce reliance on branded A N G I O M A X supply during shortages?
5. What does “manufacturer of record” mean for A N G I O M A X versus the finished-goods distributor?

References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. U.S. Food and Drug Administration. National Drug Code (NDC) Directory.
3. U.S. Food and Drug Administration. Drug Manufacturing Information (CDER facility and inspections datasets).