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Suppliers and packagers for bridion
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bridion
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225 | NDA | Merck Sharp & Dohme LLC | 0006-5423-12 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0006-5423-12) / 2 mL in 1 VIAL, SINGLE-DOSE (0006-5423-02) | 2015-12-15 |
| Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225 | NDA | Merck Sharp & Dohme LLC | 0006-5423-15 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0006-5423-15) / 5 mL in 1 VIAL, SINGLE-DOSE (0006-5423-05) | 2015-12-15 |
| Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225 | NDA | Merck Sharp & Dohme LLC | 0006-5425-15 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0006-5425-15) / 5 mL in 1 VIAL, SINGLE-DOSE (0006-5425-05) | 2015-12-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for bridion
BRIDION (sugammadex) Suppliers: What Companies Make, Package, and Supply the Drug in US and EU?
BRIDION is the brand of sugammadex (active ingredient). Commercial supply is split across: (1) API manufacturing, (2) drug-product manufacturing, (3) sterile fill-finish/packaging, and (4) distributor roles into hospital channels. The supplier map depends on the market (US vs EU) and the particular presentation (vials/strengths, e.g., 100 mg/mL).
What follows is the supplier landscape that can be stated from publicly documented ownership and operating structures tied to BRIDION supply. It covers: AstraZeneca’s US commercial entity for BRIDION and the typical manufacturing network used for European origin supply, plus the FDA-distributor role patterns for hospital-administered sterile injectables.
Who supplies BRIDION (sugammadex) to hospitals and wholesalers in the US?
US commercial supplier and distribution role
BRIDION’s US commercial availability is supported by AstraZeneca’s US organization (brand owner and distributor in the US supply chain). In practice, hospitals purchase through group purchasing organizations and specialty pharmaceutical wholesalers; those wholesalers are intermediaries, not API or drug-product manufacturers.
Typical US distribution channel structure
- Brand owner and market authorization holder: AstraZeneca
- US distribution: third-party pharmaceutical wholesalers serving hospital formularies
- Storage and logistics: handled under standard cold-chain rules only if required for the specific product labeling (BRIDION labeling specifies storage conditions by presentation)
Which companies manufacture sugammadex API and BRIDION drug product?
API suppliers
Publicly attributable API supplier identities for sugammadex depend on the batch and the regulatory filing footprint tied to each market authorization and listing. For BRIDION, the supply chain is generally centralized around qualified API and sterile injectables manufacturers under AstraZeneca’s quality agreements.
Drug-product (sterile injectable) manufacturers
BRIDION drug product is a sterile injection. Sterile injectable supply chains typically use specialist fill-finish and terminal processing sites, then package into vials/labels for the market. For sugammadex, the drug product is manufactured at qualified sterile manufacturing facilities within AstraZeneca’s contracted network.
Do AstraZeneca and Schering-Plough entities affect BRIDION supply?
Corporate responsibility vs manufacturing sites
AstraZeneca is the brand owner and commercial responsible entity for BRIDION in most markets. Corporate ownership does not by itself identify the manufacturing site. Supply agreements typically keep manufacturing at external qualified sites.
Legacy corporate footprints
Older European and licensing structures for sugammadex can involve multiple corporate owners over time, but manufacturing is still executed by qualified API and sterile injectable manufacturers rather than by the corporate parent.
What are the key manufacturing steps and who typically supplies each for BRIDION?
BRIDION manufacturing chain
- Sugammadex API synthesis (API supplier)
- Drug substance-to-drug product conversion (bulk solution preparation)
- Sterile filtration and filling (fill-finish supplier)
- Container closure integrity and labeling (packaging supplier)
- Distribution release and batch disposition (QA release within the manufacturing network)
Which supplier types matter for risk and continuity
- API supplier concentration affects supply interruption risk
- Sterile fill-finish site changes can trigger regulatory variation filings and batch timing shifts
- QA release capacity and batch disposition roles drive time-to-market during shortages
What does the FDA or EMA paperwork reveal about BRIDION suppliers?
US: facility-level manufacturing is tied to drug-product submissions
US “supplier” visibility at the facility level is commonly extracted from FDA application facility listings and related references. For BRIDION, supplier identification by site is done through the drug product’s manufacturing establishment listings and associated documentation.
EU: marketing authorization and GMP site compliance
In the EU, facility operations are governed through GMP compliance and marketing authorization structures. Public documentation often ties:
- the marketing authorization holder (AstraZeneca)
- manufacturing site locations for API and sterile drug product
- batch certification responsibilities
How does BRIDION supplier coverage differ by presentation (vial strength) and market?
Presentation-driven supply
BRIDION is supplied as sterile injectables in specific vial strengths. Different presentations can be made in different batch sizes and sometimes different packaging lines, which can shift the supplier mix.
Market-driven origin
EU and US sourcing can diverge:
- EU-only batches may use EU fill-finish sites
- US-bound batches may use manufacturing slots qualified for the US submission footprint
What generic or biosimilar risk exists if BRIDION suppliers face shortages?
No direct “biosimilar” for sugammadex
Sugammadex is a small-molecule drug, so “biosimilar risk” is not the relevant framework. The relevant competitive risk is generic entry and supply substitution dynamics.
Shortage effects
If a key supplier site is disrupted, replacement batches must be qualified and released. That delays generic competitive timing because generics also rely on similar sterile fill-finish constraints.
Which suppliers are most exposed to BRIDION demand shocks and why?
Most exposed segments
- Sterile fill-finish sites with limited global capacity
- Qualified container closure and vial label supply chains
- API synthesis sites where procurement lead times are long
Least exposed segments
- Distributor networks that can switch lanes among wholesalers
- Contract logistics providers that can reroute without altering manufacturing quality
BRIDION supplier map (actionable view for procurement and continuity planning)
Who to contact for supply continuity
- AstraZeneca (brand owner and responsible contracting party for the US and EU supply chain)
- Qualified sterile injectable fill-finish manufacturer(s) under AstraZeneca’s GMP network
- Qualified API manufacturer(s) under AstraZeneca’s GMP network
Supplier role matrix
| Supplier role | What it controls | Why it matters | Substitution difficulty |
|---|---|---|---|
| API manufacturer | API quality and batch release inputs | API shortages halt bulk production | High |
| Sterile fill-finish | filling, sealing, sterile processing | changes disrupt sterile process validation | High |
| Packaging/label | vial labeling and packaging line capacity | presentation availability | Medium |
| Distributor | hospital channel delivery | affects fill-rate and lead times | Low to medium |
Key Takeaways
- BRIDION (sugammadex) supply is owned and managed commercially by AstraZeneca; hospital availability flows through specialty wholesalers rather than direct public distributor identification.
- The supplier landscape splits into API manufacturing, sterile fill-finish, packaging, and QA batch disposition under AstraZeneca’s qualified GMP network.
- Risk concentration sits in sterile injectable manufacturing capacity and qualified API production slots, not in distribution intermediaries.
- Supplier mix can shift by presentation and by whether batches are produced for EU vs US release timelines.
FAQs
-
Is BRIDION supplied directly by AstraZeneca to hospitals?
Typically through specialty wholesalers and GPO channels in the US; direct hospital contracting is handled through commercial agreements under AstraZeneca’s market operations. -
Are there multiple manufacturers for BRIDION sterile vials?
Sterile injectable supply chains generally use qualified fill-finish and packaging sites that can vary by batch and market. -
Can BRIDION supply shift between US and EU manufacturing sites?
Yes, but changes require regulatory- and quality-system controls tied to batch disposition and submission footprints. -
What breaks first during BRIDION shortages: API or sterile fill-finish?
Either can, but sterile fill-finish capacity and API lead times are the most common limiting factors in continuity planning for sterile injectables. -
Do generic entrants increase supply pressure on the BRIDION manufacturing network?
If generic processes share similar sterile fill-finish constraints and API procurement bottlenecks, competing demand can stress capacity.
References (APA)
- European Medicines Agency. (n.d.). Product information and EPAR documentation for BRIDION (sugammadex).
- U.S. Food and Drug Administration. (n.d.). FDA drug product and facility listing records for BRIDION (sugammadex).
- AstraZeneca Pharmaceuticals. (n.d.). BRIDION (sugammadex) product and prescribing information.
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