Suppliers and packagers for emblaveo

emblaveo

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	EMBLAVEO	avibactam sodium; aztreonam	POWDER;INTRAVENOUS	217906	NDA	AbbVie Inc.	0074-3878-10	10 VIAL, SINGLE-DOSE in 1 CARTON (0074-3878-10) / 12 mL in 1 VIAL, SINGLE-DOSE (0074-3878-01)	2025-02-07

Emblaveo suppliers: who manufactures the medicine and API, contract manufacturers, and the supply chain map

Last updated: May 30, 2026

Emblaveo supply is concentrated around the drug’s commercial manufacturer(s) and their upstream API and sterile manufacturing partners. The public-facing “supplier” list for Emblaveo is typically limited to the branded-product label and FDA listing entities (application holder and listed manufacturers) rather than a full disclosure of every contract manufacturing organization (CMO) in the chain.

What is Emblaveo and which companies are listed as manufacturers on FDA labels?

Featured snippet answer: The primary “supplier” entities for Emblaveo are the label applicant/application holder and the FDA-listed manufacturing site(s) for the marketed drug product, which are the companies that populate the Drug Approvals and Orange Book manufacturing fields.

What active ingredient does Emblaveo contain?

Emblaveo is marketed as a prescription antibacterial combination. The exact actives and dosage forms are defined by the approved NDA or BLA and appear in the FDA label and Orange Book listings.

Who typically appears as the “manufacturer” for Emblaveo?

For each Emblaveo strength and dosage form, the FDA label usually lists:

• Application holder (NDA/BLA holder)
• Manufacturers of finished dosage form (drug product)
• Manufacturers of API (less consistently shown in public label text, but captured in FDA databases and registrations)

Where is Emblaveo produced: drug product manufacturing sites and sterile fill-finish?

Featured snippet answer: Emblaveo is produced through one or more drug product manufacturing sites listed in FDA systems for the specific dosage form (commonly including sterile manufacturing and fill-finish for parenteral products, if applicable).

Which manufacturing steps drive supplier selection?

Supplier qualification for hospital/IV antibiotics typically hinges on:

• Sterile drug product manufacturing capability
• Component procurement for IV administration (containers, closures, diluents where applicable)
• A validated analytical package supporting batch release and stability
• GMP documentation systems that satisfy NDA/label change controls

How to map the Emblaveo supply chain using FDA fields

The practical way pharma buyers and competitors validate “supplier” risk is to cross-check:

• FDA label “Manufactured for” / “Distributed by” sections (application holder and commercial packaging)
• FDA listing for “Applicant” and “Manufacturer” per product strength
• State corporate entities and plant addresses on the manufacturing lines (registrations)

How can you identify Emblaveo API suppliers versus drug product manufacturers?

Featured snippet answer: API suppliers are usually disclosed through FDA registration and listing records (and sometimes through patent assignees), while drug product manufacturers are more consistently visible on the label and listing databases.

API source patterns for branded antibiotics

For branded combination antibacterials, API supply can come from:

• In-house upstream manufacture at the application holder’s sites, or
• Contract API synthesis and purification by dedicated chemical CMOs

What data sources are used to distinguish API vs finished drug suppliers?

• FDA registrations and listings (site and company)
• Orange Book “Manufacturers” fields when present for the approved product
• Patent family assignees tied to the API and drug substance manufacturing methods

Which CMOs can supply Emblaveo drug product and packaging?

Featured snippet answer: CMO names are discoverable only where the FDA listing and plant registrations name the contract manufacturer responsible for the marketed dosage form. Without those specific FDA record extracts for Emblaveo, no complete CMO roster can be stated.

What to look for in Emblaveo commercial records

A complete “CMO roster” for Emblaveo would identify, per strength:

• Final dosage form manufacturer company and site
• Sterile fill-finish and packaging sites (if different)
• Labeler and distribution entity (if separate)

What suppliers support Emblaveo formulation technology and stability requirements?

Featured snippet answer: Suppliers for formulation and stability-critical components are constrained by GMP supply agreements for excipients, container-closure systems, and sterile manufacturing materials.

Container-closure and excipient supplier dependencies

For IV antibiotics, procurement bottlenecks often come from:

• Glass/plastic container formats used in sterile fill-finish
• Rubber closures and seals
• Critical excipients and buffering agents
• Transfer and filtration components used in sterile processing

What supplier risks matter for Emblaveo continuity of supply?

Featured snippet answer: The highest-risk supplier constraints for complex antibacterials typically arise from single-site sterile manufacturing, limited fill-finish line capacity, and API upstream concentration.

Where shortages usually originate

• API synthesis capacity constraints for one component of the combination
• Raw material purity excursions
• Sterile production line downtime (sterilizer cycles, aseptic interventions)
• Transportation and cold chain handling if required by the label

How does Emblaveo procurement compare with other IV antibiotics on supplier concentration?

Featured snippet answer: Like other branded IV antibiotics, Emblaveo supply concentration can be mapped by comparing FDA manufacturer site counts and the presence of multiple plants across label strengths. More plants generally means lower supplier single-point-of-failure risk.

Benchmarking dimensions

• Number of drug product manufacturing sites listed for the marketed strengths
• Whether alternate vendors are listed for API
• Whether packaging and labeling are performed by the application holder or outsourced

Key tables for building an Emblaveo supplier map from FDA listings

Emblaveo supplier mapping template (to populate from FDA label and listing records)

Emblaveo item	What to collect	Where it appears in FDA materials
Application holder	NDA/BLA holder	FDA label, FDA product listing
Drug product manufacturer(s)	Company + site address	FDA label manufacturing statement; product listing
API manufacturer(s)	Company + site address	FDA registrations/listing fields (where shown)
Dosage form/strength	Strength-specific suppliers	Orange Book listing per strength
Packaging/labeling	Labeler vs manufacturer entity	Label “Distributed by / Manufactured for”
Sterile fill-finish	Site(s) and whether separate	Manufacturing statement and site lists

Key Takeaways

• “Suppliers” for Emblaveo in regulated markets are primarily the application holder and FDA-listed drug product manufacturing sites tied to the marketed strengths.
• API supplier names, when needed for procurement due diligence, are usually recoverable through FDA registrations/listings and upstream patent family assignments, not from the consumer-facing label.
• A defensible supplier map for Emblaveo is built from the FDA label manufacturer statements plus FDA listing records per strength and dosage form.

FAQs

1. How do I find the FDA-listed manufacturer for a specific Emblaveo strength?
   Use the FDA label manufacturing statement and the product listing entry for that strength, then match the “manufacturer” entity to the site address.

2. Are Emblaveo API suppliers listed publicly in the label?
   Often not directly; API suppliers are more consistently identified through FDA registrations and listings linked to the drug substance.

3. What is the fastest way to assess Emblaveo single-point-of-failure risk?
   Compare the number of FDA-listed drug product manufacturing sites across all Emblaveo strengths and confirm whether sterile fill-finish is single-site.

4. Do patent assignees for Emblaveo indicate API or manufacturing suppliers?
   Patent assignees can correlate with technology holders and sometimes with manufacturing capability, but they do not guarantee the actual GMP supplier of record.

5. How do Emblaveo supply chain dependencies change during generic or biosimilar entry?
   Changes depend on whether there is API re-sourcing, contract manufacturing qualification, and whether multiple plants are already FDA-listed for the marketed product.

References

No sources were cited because no FDA label, Orange Book entry, or manufacturer-listing record for Emblaveo was provided in the prompt.