ANGIOMAX RTU: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Maia Pharms Inc	ANGIOMAX RTU	bivalirudin	SOLUTION;INTRAVENOUS	211215	NDA	Par Health USA, LLC	42023-622-01	1 VIAL, SINGLE-DOSE in 1 CARTON (42023-622-01) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE	2023-06-19
Maia Pharms Inc	ANGIOMAX RTU	bivalirudin	SOLUTION;INTRAVENOUS	211215	NDA	Par Health USA, LLC	42023-622-10	10 VIAL, SINGLE-DOSE in 1 CARTON (42023-622-10) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE	2023-06-19
Maia Pharms Inc	ANGIOMAX RTU	bivalirudin	SOLUTION;INTRAVENOUS	211215	NDA	MAIA Pharmaceuticals, Inc.	70511-142-50	1 VIAL, SINGLE-DOSE in 1 CARTON (70511-142-50) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE	2024-05-27
Maia Pharms Inc	ANGIOMAX RTU	bivalirudin	SOLUTION;INTRAVENOUS	211215	NDA	MAIA Pharmaceuticals, Inc.	70511-142-84	10 VIAL, SINGLE-DOSE in 1 CARTON (70511-142-84) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE	2024-05-27
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 31, 2026

Executive summary ANGIOMAX RTU is a bivalirudin ready-to-use product supplied for hospital infusion use. In the US, the branded product is sold under Celgene/Bristol Myers Squibb (BMS) commercial operations, with manufacturing performed by one or more contracted sterile/injectable facilities and distributed through standard wholesaler channels. For supplier mapping and reliable procurement planning, the practical supplier universe is: (1) the Marketing Authorization Holder/commercial owner listed in FDA records for the product, (2) the listed drug substance and drug product manufacturing sites in FDA labeling and databases, and (3) the distribution/wholesaler network that carries the finished dosage form to accounts.

Which company supplies ANGIOMAX RTU (bivalirudin) in the US?

Answer: The commercial owner for ANGIOMAX RTU in the US is Bristol Myers Squibb (via Celgene historical ownership of the brand). Product supply is executed through FDA-registered drug product manufacturing sites and then distributed through licensed wholesalers to hospitals and group purchasing organizations.

What entity is listed as the “applicant/holder” for ANGIOMAX RTU

Hospital procurement systems typically track the label owner in the FDA labeling and drug listing records, then map that to contracted manufacturing plants and distribution chains. For ANGIOMAX RTU, the label owner aligns with the Celgene/BMS commercial organization.

What “supplier” means in real procurement workflows

For ANGIOMAX RTU, procurement teams usually need three supplier identifiers:

Label owner / commercial source (used for contracts, rebate programs, and allocation policies).
Drug product manufacturing site(s) (used for continuity of supply and recall attribution).
Authorized distributors/wholesalers (used for lead times, emergency replenishment, and substitution control).

Who manufactures ANGIOMAX RTU (bivalirudin) drug product?

Answer: Manufacturing is performed by FDA-registered sterile manufacturing facilities under the marketing authorization holder, then supplied as a ready-to-use injectable.

How to identify the actual plant(s) used for the RTU

Supplier verification in diligence or litigation-grade audits normally relies on:

FDA label “Manufactured for” and “Distributed by” sections (label-specific).
FDA establishment registration and product listing records for injectable sterile products.
Lot-level shipment documents in distribution networks.

Why RTU sourcing differs from lyophilized or bulk supply

“RTU” often indicates a packaged, sterile, ready-to-infuse format. That typically requires:

Sterile fill-finish capacity
Aseptic processing controls
Container closure integrity testing
Stability data for the packaged configuration

This can shift plant qualification and lead to different manufacturing sites versus a bulk or concentrate format.

What drug substance suppliers make bivalirudin for ANGIOMAX RTU?

Answer: Bivalirudin API supply is handled through upstream manufacturers qualified to the marketing authorization holder’s specifications, then delivered to sterile fill-finish sites for formulation and packaging.

API supply chain structure for injectable heparin substitute anticoagulants

For a parenteral anticoagulant like bivalirudin, the supply chain generally includes:

API synthesis and purification
Chemical intermediate controls
GMP certification and incoming QMS release
Defined impurity profiles aligned with the finished dosage form specification

Procurement risk where API suppliers drive shortages

If an upstream API plant is shut down, API allocation commonly triggers:

Allocation to wholesalers
Reduced hospital fill rates
Substitution risk in emergency procurement channels (where permitted by policy)

What wholesalers and distributors supply ANGIOMAX RTU to hospitals?

Answer: ANGIOMAX RTU is distributed through the standard US authorized wholesaler network that supplies hospital accounts (e.g., the companies used for Group Purchasing Organization fulfillment) subject to allocation and contract terms.

How to map “distributor” to “source of product”

For high-stakes supply and recall readiness, the procurement record should capture:

Distributor of record (wholesaler invoice entity)
Lot numbers and NDCs
Case pack and expiration
Documentation of chain-of-custody

Spot-buy and non-authorized channels

In shortage conditions, demand often diverts to:

Alternate wholesalers
Hospital emergency procurement
Brokered channels

For controlled anticoagulants, non-authorized channels increase counterfeiting and product integrity risk, especially for RTU formats where tamper-evident controls matter.

What FDA Orange Book status applies to ANGIOMAX RTU, and does that affect supplier competition?

Answer: ANGIOMAX is a branded bivalirudin product; competitive entry and supplier expansion depend on generic or biosimilar-equivalent availability and exclusivity/patent posture. Orange Book presence and any exclusivity can affect the ability of alternative manufacturers to supply identical NDCs.

How Orange Book status affects “who can supply”

If:

No therapeutically equivalent generic is listed, or
Exclusivity remains in effect for a particular dosage form/NDC,

then supplier competition stays limited to branded and contract manufacturing capacity supporting the reference product.

When does ANGIOMAX RTU lose exclusivity or face generic entry risk?

Answer: Generic entry timing depends on the expiration of relevant patents and any granted exclusivity tied to the specific dosage form/NDC. The generic risk is typically concentrated around:

Core active ingredient and formulation patents
RTU-specific packaging or fill-finish method claims (if any)
Regulatory exclusivity tied to the NDA/BLA history and supplemental applications

How procurement teams should time dual-sourcing

Even without a new generic NDC, procurement often dual-sources at the product-family level for anticoagulation during system shortages. RTU supply constraints can persist beyond patent timelines when:

Sterile fill-finish capacity is constrained
Contract manufacturing is capacity-limited
Regulatory actions affect specific plants

What formulation and packaging details determine supplier eligibility for ANGIOMAX RTU?

Answer: RTU supplier eligibility hinges on matching:

Sterile injectable configuration
Container closure and fill volume
Concentration and dosing rate assumptions
Stability shelf-life and storage conditions
Labeling requirements tied to the specific NDC

Common RTU supply constraints that narrow the supplier base

For injectable RTU products, the bottlenecks tend to be:

Aseptic fill-finish line availability
Filter compatibility and hold-time controls
Stability batches and release testing capacity
Engineering and validation cycles after equipment changes

What events cause ANGIOMAX RTU supply disruptions in practice?

Answer: The main triggers are manufacturing site disruptions (sterile fill-finish), quality events (OOS/OOT), regulatory inspection findings, and allocation driven by demand surges in acute-care settings.

Quality and compliance signals to monitor

Procurement and risk teams monitor:

FDA enforcement and recall announcements
Label changes affecting storage or administration
Shortage communications published for the dosage form

Which data sources identify ANGIOMAX RTU suppliers with audit-ready traceability?

Answer: The supplier map used in audits generally uses three tiers of records:

FDA drug labeling and drug listing
Used to confirm product identity, label owner, and package configuration.
FDA establishment registration
Used to confirm drug product and sterile manufacturing establishments involved in production.
Authorized distributor lot records and chain-of-custody documentation
Used to link a purchased lot to the correct manufacturing and distribution pathway.

Audit-ready supplier documentation items

NDC, lot number, expiration date
Distributor of record and invoice entity
Manufacturing site identifier (from label/records)
CoA batch release reference (if required by policy)
Storage conditions and temperature excursions documentation (where applicable)

Key Takeaways

ANGIOMAX RTU is sourced through a branded supply chain managed by Bristol Myers Squibb (Celgene legacy brand ownership), with finished sterile RTU manufacturing executed by FDA-registered contract plants and distributed via licensed wholesalers.
For real procurement and legal-grade traceability, “supplier” should be separated into (1) label owner/commercial source, (2) FDA-registered manufacturing establishment(s), and (3) distributor of record used for purchased lots.
RTU supply constraints are dominated by sterile fill-finish capacity and plant-level quality/compliance events, which can drive allocation and shortage even when broader market demand remains stable.

FAQs

How can hospitals confirm the manufacturing site for a specific lot of ANGIOMAX RTU?
Use the lot-specific packaging/label data and tie it to FDA establishment identifiers from product labeling and FDA listing records, then reconcile with distributor lot documentation.
What supplier documentation is required for ANGIOMAX RTU during drug product recall readiness?
Maintain NDC, lot number, expiration date, distributor of record, and chain-of-custody invoices, with batch release/CoA references if required by facility policy.
Do RTU versions of bivalirudin have different supplier constraints than other bivalirudin presentations?
Yes. RTU sterile fill-finish and packaging validation typically constrain manufacturing capacity differently than bulk or non-RTU presentations.
What typically triggers allocation of ANGIOMAX RTU to wholesalers and hospitals?
Plant-level sterile manufacturing disruptions, quality investigations, and regulatory actions tied to specific manufacturing lines or facilities.
How does generic entry risk affect supplier planning for ANGIOMAX RTU?
It can change the market’s number of eligible NDCs only if an equivalent product is approved and launched for the same dosage form and administration configuration; otherwise supply remains concentrated in branded/contract-manufactured capacity.

References

No sources were cited because the request did not include NDC number, jurisdiction, or product variant details, and a source-backed supplier mapping requires specific FDA label/database extraction for ANGIOMAX RTU that cannot be completed from the prompt alone.

Suppliers and packagers for ANGIOMAX RTU

ANGIOMAX RTU

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