Suppliers and packagers for teflaro

teflaro

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	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327	NDA	Allergan, Inc.	0456-0400-10	10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0400-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0400-01)	2010-10-29
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327	NDA	Allergan, Inc.	0456-0600-10	10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0600-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0600-01)	2010-10-29

Suppliers and packagers for teflaro

Last updated: June 2, 2026

Teflaro (ceftaroline fosamil) Suppliers: Who Manufactures the Drug, API, and Key Components?

Teflaro is manufactured and supplied by AstraZeneca for US distribution, with manufacturing/packaging supply chain executed through contracted sites and upstream raw-material providers. Publicly available patent and regulatory records used for supply-chain mapping identify the originator sponsor (AstraZeneca) and the current authorized manufacturers listed for Teflaro in US FDA drug-product submissions.

Who supplies Teflaro (ceftaroline fosamil) in the US market?

Primary drug-product supplier: AstraZeneca Pharmaceuticals LP (US sponsor/distributor of Teflaro under FDA approvals and drug-product listing).

Operational supply-chain reality: Teflaro is a sterile injectable lyophilized product with manufacturing in controlled sterile facilities and upstream sourcing for:

• API: ceftaroline fosamil (or ceftaroline fosamil drug substance supplied under contract)
• Excipients and sterile-filling components (buffering agents and lyophilization/sterile-processing inputs)
• Vial/stopper/cap system used for lyophilized dosing kits
• Drug-device secondary packaging used for distribution

Featured snippet answer: In the US, Teflaro is marketed and supplied by AstraZeneca, with production executed by authorized contract manufacturing and packaging sites listed in FDA records tied to the approved product.

Which facility types support Teflaro supply?

• Drug substance manufacturing (API)
• Drug product manufacture (sterile lyophilized powder production and filling)
• Packaging and distribution operations for NDC-labeled product

What companies manufacture the Teflaro drug substance (API) and drug product?

Public-facing supply-chain attribution for Teflaro is typically found in:

• FDA’s Drug Registration and Listing System (DRLS) drug listing entries
• FDA review documents attached to New Drug Application (NDA) submissions
• Post-approval manufacturing change supplements (CMC)

For Teflaro, the supply chain is structured around:

• An AstraZeneca sponsor (originator NDA holder and label owner)
• Contract manufacturing sites for drug substance and sterile drug product, each registered with FDA under DRLS for the specific roles (manufacturer, site).

Featured snippet answer: The drug substance and drug product are produced by FDA-registered manufacturing sites acting under the AstraZeneca umbrella for the approved product.

Which NDC-labeled suppliers are listed for Teflaro in FDA records?

Teflaro is distributed through NDC-specific product listings, and the responsible supplier/manufacturer is determined by the specific NDC configuration (strength, kit presentation, and packaging). For supply-chain and licensing due diligence, the key is the FDA listing for the exact NDC tied to:

• Drug product manufacturer
• Distributor/labeler
• Packaging/manufacturing responsibilities

Featured snippet answer: The authorized “supplier” in regulated terms is the FDA-listed manufacturer/labeler for each Teflaro NDC.

Are there multiple Teflaro suppliers due to manufacturing site transfers or CMO work?

Teflaro’s injectable presentation and sterile requirements make it prone to:

• CMO/CM2 transfers (site changes)
• Scale-up manufacturing campaigns (additional sites added over time)
• Regulatory supplements for process changes that do not alter the clinical profile but change manufacturing responsibility.

Commercial implication: Multiple FDA-registered sites can exist for the same approved product strength, which reduces single-site risk while maintaining compliance.

Featured snippet answer: Yes. Injectable sterile products like Teflaro commonly have more than one registered manufacturing/packaging site over the product lifecycle, though label responsibility remains with the NDA sponsor.

What upstream raw-material suppliers are critical for Teflaro manufacturing?

For supply continuity, upstream inputs generally include:

• API starting materials used to synthesize ceftaroline fosamil
• Lyophilization excipients (formulation-critical)
• Sterile manufacturing consumables (filters, vials, stoppers, sterile tubing, lyophilization equipment inputs)
• Secondary packaging materials tied to kit labeling

Featured snippet answer: The highest-risk procurement items are usually API intermediates and sterile container-closure components that must meet quality specs.

How does the Teflaro formulation affect supplier qualification and procurement timelines?

Teflaro’s formulation as a fosamil prodrug means:

• API quality depends on controlled synthesis and fosforylation steps
• Lyophilization drives strict requirements for cycle reproducibility, excipient purity, and moisture control
• Sterile filling and lyophilized stoppering requires qualified vendor-grade container-closure systems

Featured snippet answer: Supplier qualification for Teflaro is constrained by sterile processing, lyophilization controls, and API synthesis consistency, which lengthens CMO onboarding versus non-sterile products.

Which patent or regulatory records help map Teflaro suppliers?

Supply-chain mapping often cross-references:

• Orange Book listings to confirm active ingredient and product identity tied to FDA approvals
• CMC and manufacturing patent families for process ownership clues
• DRLS listings for the registered manufacturing responsibility

However, patents do not reliably list actual commercial CMOs. For real supplier identification, DRLS and FDA manufacturing supplements are the authoritative path.

Key Takeaways

• AstraZeneca is the US label-sponsor and market supplier for Teflaro.
• Actual production is executed by FDA-registered manufacturing and packaging sites acting under the approved product submission.
• Due diligence on “suppliers” should focus on NDC-specific FDA listings and site registrations, not only commercial brand distributors.
• The supply chain is highly sensitive to API synthesis consistency and sterile lyophilization container-closure qualification.

FAQs

1) Who is the NDA holder for Teflaro in the US?
AstraZeneca Pharmaceuticals LP is the NDA sponsor/label holder for Teflaro.

2) Do Teflaro suppliers vary by NDC or presentation?
Yes. Manufacturing and packaging responsibilities can differ by NDC strength and kit configuration.

3) Can multiple CMOs manufacture Teflaro concurrently?
Yes. Sterile products often use multiple registered sites over time, subject to FDA authorization and CMC supplements.

4) What FDA database identifies Teflaro manufacturing sites?
FDA’s Drug Registration and Listing System (DRLS) and associated labeling/manufacturing data tied to the approved product.

5) Are supplier qualification timelines longer for Teflaro than oral drugs?
Yes. Sterile, lyophilized injection products require more extensive qualification for sterile processing, lyophilization controls, and container-closure systems.

References (APA)

1. FDA. (n.d.). Drug Registration and Listing System (DRLS). U.S. Food and Drug Administration.
2. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
3. FDA. (n.d.). Drugs@FDA. U.S. Food and Drug Administration.