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Suppliers and packagers for XENLETA
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XENLETA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hong Kong | XENLETA | lefamulin acetate | SOLUTION;INTRAVENOUS | 211673 | NDA | Meitheal Pharmaceuticals Inc. | 71288-039-16 | 6 VIAL, SINGLE-USE in 1 CARTON (71288-039-16) / 15 mL in 1 VIAL, SINGLE-USE (71288-039-15) | 2019-09-09 |
| Hong Kong | XENLETA | lefamulin acetate | SOLUTION;INTRAVENOUS | 211673 | NDA | Meitheal Pharmaceuticals Inc. | 71288-040-65 | 6 BAG in 1 CARTON (71288-040-65) / 270 mL in 1 BAG (71288-040-64) | 2019-09-09 |
| Hong Kong | XENLETA | lefamulin acetate | TABLET;ORAL | 211672 | NDA | Meitheal Pharmaceuticals Inc. | 71288-037-10 | 10 TABLET, COATED in 1 BLISTER PACK (71288-037-10) | 2019-09-09 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for XENLETA
XENLETA (lefamulin) Suppliers: Who Manufactures and Supplies the Drug in Key Markets
XENLETA is supplied in the US by Nabriva Therapeutics. Drug substance and drug product manufacturing is handled by external contract manufacturing organizations, with site-specific details tied to filings and inspections. Public, definitive supplier names can vary by market and dosage form (IV versus oral) and by packaging configuration; they must be confirmed from the relevant FDA drug label manufacturing/packaging section, Orange Book listing entries, and current GMP inspection coverage.
Who are the manufacturers and suppliers of XENLETA (lefamulin) in the US?
Answer: The labeled US supplier/holder is Nabriva Therapeutics; manufacturing responsibility is distributed across contract manufacturing sites for drug substance and drug product.
US label: who is listed for manufacturing and distribution?
- The US prescribing information identifies the marketing authorization holder and lists manufacturers for drug product (and sometimes packaging) and the distributor depending on label version.
- For XENLETA, the key supplier construct for procurement and compliance is:
- Marketing authorization holder / label sponsor: Nabriva Therapeutics
- GMP manufacturer(s): external facilities named in the label “Manufactured for” / “Distributed by” sections (varies by label edition and dosage form)
Which dosage forms create separate supply chains?
- IV formulation (lefamulin injection)
- Oral formulation (lefamulin tablets)
These typically use different manufacturing lines and often different packaging suppliers, even when the same drug substance provider is used.
What contract manufacturing organizations make XENLETA injection and tablets?
Answer: XENLETA’s drug product is manufactured by GMP contract manufacturers named on the most current product label and supply chain statements; external sites are used for both injection and tablets.
Injection (lefamulin IV) supply
Key procurement-relevant items:
- Sterile drug product manufacturing
- Aseptic fill-finish capability
- Labeling and kit configuration for distribution
Tablets (lefamulin oral) supply
Key procurement-relevant items:
- Solid oral manufacturing
- Tablet compression and coating lines
- Packaging format supplier (bottle/blister)
What suppliers provide lefamulin drug substance for XENLETA?
Answer: XENLETA uses external drug-substance manufacturing. The drug substance vendor is typically identified through:
- the FDA label (if disclosed),
- CMC sections in filings (not fully public at facility level),
- and inspection records tied to the labeled manufacturer/shipper.
How to map “supplier” vs “manufacturer” for lefamulin
- “Supplier” in commercial terms often means:
- labeled manufacturer/packager
- or distributor
- “Manufacturer” in regulatory terms is:
- the site that holds responsibility for GMP release of drug product
- Drug substance providers may not be fully disclosed on the commercial label, even when drug product sites are.
Which companies are in the XENLETA supply chain beyond Nabriva?
Answer: Beyond Nabriva Therapeutics, the supply chain includes:
- GMP drug product manufacturers named on the label
- packaging contractors and logistics partners used for US distribution
Procurement and quality interfaces
For contracting and quality agreements, buyers typically require:
- QMS and change control covenants
- CoA and batch release documentation
- master batch record access and audit terms
- serialization and track-and-trace readiness where applicable
What does the Orange Book list for XENLETA, and does that identify suppliers?
Answer: XENLETA’s Orange Book listing generally identifies application holder and patent information; it may not list all manufacturing suppliers at facility granularity.
Why Orange Book entries don’t fully solve “supplier”
- Orange Book is oriented around:
- active ingredient
- dosage form
- patent claims and exclusivity
- Facility-level suppliers come from:
- FDA label manufacturing sections
- CMC disclosures
- inspection assignments
Is XENLETA supplied through shared manufacturing with other pleuromutilin antibiotics?
Answer: There can be shared capabilities across contractors (sterile fill-finish, solid oral lines), but facility-sharing is not stated as a general rule for XENLETA. Supply chain commonality must be confirmed per labeled manufacturing sites.
How to assess manufacturing overlap operationally
- Compare label “Manufactured for” sites across:
- injection versus tablets
- prior label versions (if suppliers changed)
- any authorized partner products (if applicable)
What XENLETA supplier risks affect availability (API or fill-finish constraints)?
Answer: The highest availability risks typically come from:
- sterile aseptic fill-finish capacity for injection
- tablet solid oral manufacturing bottlenecks
- packaging format dependence
- API supply continuity for lefamulin drug substance
Risk categories procurement teams evaluate
- single-site release dependency
- lead time variability on primary packaging components
- raw material or excipient shortages
- change-control events (scale-up, line transfer, equipment replacement)
How does XENLETA’s dosage-form manufacturing differ supplier-by-supplier?
Answer: Different contractors frequently handle injection and tablets due to different GMP requirements.
Injection vs oral: manufacturing requirements
- Injection: sterile filtration/aseptic processing, environmental monitoring, container-closure integrity verification
- Tablets: granulation, compression, coating, stability controls, and solid-state characterization
Key Takeaways
- Nabriva Therapeutics is the US label holder and primary supplier interface for XENLETA.
- GMP drug product manufacturing is performed by contract manufacturers named in the current prescribing information; injection and tablets typically use different supply chain partners.
- Drug substance suppliers for lefamulin are often not fully visible from Orange Book alone; they are mapped via label manufacturing sections, CMC disclosures, and inspection-linked sites.
- Supply risk is most sensitive to:
- sterile fill-finish capacity for IV
- solid oral production and packaging for tablets
- continuity of le famulin API sourcing
FAQs
1) Does XENLETA use a single manufacturer for both injection and tablets?
Label manufacturing sections must be checked per dosage form. The common pattern is different drug product manufacturers for injection vs tablets.
2) Are XENLETA manufacturing sites listed on the FDA label?
Yes, the label typically names the drug product manufacturer(s) and distributor/packager where applicable.
3) Do generic or authorized suppliers have alternative XENLETA manufacturing rights?
No XENLETA generics are equivalent in labeling supplier terms while product exclusivity and patent status are in force; any future entrants use their own CMO plants.
4) How can procurement confirm batch-release manufacturing for XENLETA?
Use the CoA, lot traceability documentation, and the label “Manufactured for” site matched to batch records.
5) What manufacturing change events most impact XENLETA supply continuity?
Aseptic line availability for injection, solid oral line capacity for tablets, and primary packaging component constraints.
References
- FDA. “XENLETA (lefamulin) Prescribing Information.” US Prescribing Information (current label). U.S. Food and Drug Administration.
- FDA. “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.” XENLETA (lefamulin) entries. U.S. Food and Drug Administration.
- FDA. “Drug Manufacturing Inspections.” Database and inspection information related to labeled manufacturing sites. U.S. Food and Drug Administration.
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