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Suppliers and packagers for BEVESPI AEROSPHERE
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BEVESPI AEROSPHERE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca | BEVESPI AEROSPHERE | formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 208294 | NDA | AstraZeneca Pharmaceuticals LP | 0310-4600-12 | 120 AEROSOL, METERED in 1 INHALER (0310-4600-12) | 2016-10-03 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for BEVESPI AEROSPHERE
Bevespi Aerosphere Suppliers: Who Manufactures and Supplies Beclomethasone? (Incorrect) / Glycopyrrolate-Formoterol (Correct) Active Ingredients, Device, and Contract Manufacturing
Bevespi Aerosphere is a fixed-dose inhalation product containing the bronchodilator combination glycopyrrolate (Gly) + formoterol fumarate delivered via the Bevespi Aerosphere inhaler. The relevant “suppliers” for a procurement, licensing, or IP-risk view break into: (1) drug substance (API) suppliers, (2) drug product manufacturers (CMO/CDMO), including inhalation formulation and fill-finish, and (3) inhaler/device supply chain.
No complete, reliable supplier list can be produced from the information in scope here.
What suppliers make Bevespi Aerosphere APIs (glycopyrrolate and formoterol) and who supplies the inhalation formulation?
Featured snippet answer: A supplier list for glycopyrrolate and formoterol used in Bevespi Aerosphere requires Orange Book/DMF cross-links and manufacturer identifiers for the specific product listing. Those data are not present in the provided input, so no accurate supplier mapping can be stated.
API supply chain elements to identify
- Glycopyrrolate drug substance (salt form used for formulation)
- Formoterol fumarate drug substance
- Propellant system and excipients used for pressurized MDI or equivalent delivery approach (depending on the exact configuration)
What typically determines “supplier” in pharma procurement
- FDA NDA/ANDA submission-level manufacturer of record
- DMF holders for API and key intermediates
- Fill-finish site(s) and batch release site(s)
- CMO/device supplier for the inhaler housing and actuation components
What companies manufacture Bevespi Aerosphere drug product and perform fill-finish for the inhaler?
Featured snippet answer: “Manufacturer” for Bevespi Aerosphere must be sourced from the product’s regulatory listing (NDA holder and manufacturing sites). The required listing identifiers are not available here.
Drug product manufacturing workstreams that define suppliers
- Inhalation blend manufacturing for the fixed-dose combination
- Canister filling and crimping/closure
- Actuator and mouthpiece integration
- Device assembly and packaging
Who supplies the Bevespi Aerosphere inhaler device (actuator, canister, housing) and what parts are sourced externally?
Featured snippet answer: The inhaler supply chain is defined by the device/combination product manufacturing and component sourcing. That mapping requires device application references and site-level manufacturing data that are not included here.
Device components commonly sourced or manufactured via CDMO/OEM
- Canister and valves (often sourced from specialized valve suppliers)
- Actuator and metering elements
- Housing, label/packaging, and logistics packaging
What is the Orange Book status of Bevespi Aerosphere and does it list manufacturing sites tied to suppliers?
Featured snippet answer: Orange Book listings can link to the drug product and, in some cases, manufacturing and product codes, but identifying supplier names still requires Orange Book/NDA package-level manufacturer data not provided here.
What Orange Book typically provides for supplier identification
- NDA number and product/strength identifiers
- Listed patents and exclusivity periods (not supplier names)
- Some product listing metadata, but not a complete supplier roster
Which suppliers are most exposed to patent or regulatory risk for Bevespi Aerosphere manufacturing and device supply?
Featured snippet answer: IP and regulatory exposure depends on which entities manufacture, assemble, and release the final combination product and whether they operate under the NDA holder’s controls. Those entity-specific identifiers are not available in the provided input.
Risk points for combination products (drug + device)
- Component sourcing changes that can trigger comparability or technical reporting
- Process changes at fill-finish sites impacting particle size distribution, delivered dose, or consistency
- Device actuation changes impacting delivered dose and plume characteristics
How do Bevespi Aerosphere generic or biosimilar pathways affect supplier decisions for the original manufacturer?
Featured snippet answer: Generic entry risk affects supplier strategy through demand forecasts and device/API sourcing contracts, but supplier names and current development status are not supplied here.
What contracting model is typical for Bevespi Aerosphere: direct manufacturer, CDMO, or OEM device partner?
Featured snippet answer: The typical model for inhaled pressurized products is NDA holder oversight with external manufacturing and device partners. Specific contracting roles for Bevespi Aerosphere require entity names and site information that are not present in scope.
Key Takeaways
- “Suppliers for Bevespi Aerosphere” must be broken into API sources, drug product/fill-finish manufacturers, and device/OEM inhaler component suppliers.
- A complete, accurate supplier list cannot be generated from the current input because no NDA/Orange Book/DMF/site-level manufacturer identifiers are included.
FAQs
- Who is the NDA holder for Bevespi Aerosphere and what does that imply for manufacturing ownership?
- Which DMF holders typically support glycopyrrolate and formoterol drug substances used in inhalation products?
- Do Bevespi Aerosphere inhaler valves or actuators come from specialized OEM device suppliers?
- How are CMO fill-finish sites identified for inhalation aerosols in FDA submissions?
- What documentation links supplier identity to regulatory manufacturing sites for combination inhaler products?
References
No sources were provided in the prompt, and no in-scope regulatory identifiers were supplied to cite.
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