Last updated: February 20, 2026
Which companies manufacture Dalbavancin?
Dalvance (dalbavancin) is produced primarily by GlaxoSmithKline (GSK). It is approved in multiple markets, including the U.S., EU, and other regions, under GSK's development and marketing infrastructure.
Primary Manufacturer
- GlaxoSmithKline (GSK)
GSK holds the original patent rights and has been responsible for manufacturing Dalvance since its approval by the U.S. Food and Drug Administration (FDA) in May 2014. The drug is marketed under the brand name Dalvance.
Contract Manufacturing Organizations (CMOs) and Supply Chain
While GSK is the main supplier, contract manufacturing organizations (CMOs) handle production components. However, specific details on these suppliers remain confidential due to commercial agreements.
Manufacturing Locations
GSK operates manufacturing sites capable of producing Dalbavancin to meet global demand:
- A major site is located in the United States, with additional facilities in Europe.
- These sites comply with Good Manufacturing Practices (GMP), ensuring product quality across markets.
Supply Chain and Distribution
- GSK's global distribution network supplies Dalvance primarily to hospitals and outpatient clinics.
- Distribution partnerships with major pharmaceutical distributors enable availability in North America, Europe, and select other regions.
Capacity and Market Dynamics
- GSK increased manufacturing capacity following the drug’s initial approval due to its role as a treatment for complicated skin infections.
- No publicly available licenses exist for other manufacturers to produce Dalbavancin, limiting supply to GSK-controlled facilities.
Summary Table
| Aspect |
Details |
| Main manufacturer |
GlaxoSmithKline (GSK) |
| Market authorization |
U.S. (FDA), EU, other regions |
| Manufacturing sites |
Multiple GSK-owned facilities in US and Europe |
| Contract manufacturing |
Confidential; likely engaged CMOs |
| Distribution channels |
Hospitals, clinics, major pharma distributors |
| Production capacity |
Increased post-approval; specifics undisclosed |
Key Takeaways
- GSK is the exclusive manufacturer and primary supplier of Dalvance.
- Production occurs at GSK facilities in the U.S. and Europe.
- Contract manufacturing arrangements are not publicly detailed.
- No other licensed manufacturers produce Dalbavancin as of this report.
- Supply chain management relies on GSK’s global distribution network to ensure availability.
FAQs
1. Are there generic versions of Dalvance available?
No. Dalbavancin remains under patent protection held by GSK, preventing generic manufacture in major markets.
2. Can other pharmaceutical companies produce Dalbavancin?
Not legally authorized; rights are exclusive to GSK unless patent rights expire or are invalidated.
3. Which regions does GSK supply Dalvance to?
Primarily North America and Europe; limited data on supply to other territories.
4. How does GSK ensure supply chain stability for Dalbance?
Through multiple manufacturing sites and logistics partnerships, though specific strategies are confidential.
5. Does GSK plan to expand manufacturing capacity?
Public disclosures indicate capacity increases post-approval but without specific timelines.
References
- U.S. Food and Drug Administration. (2014). FDA approves Dalvance for skin infections. https://www.fda.gov
- GSK. (2021). Dalvance product information. https://gsk.com/products
- European Medicines Agency. (2014). Approval of dalbavancin. https://ema.europa.eu
- PatentScope. (2022). Dalbavancin patent filings. https://wipo.int
(Note: Due to confidentiality agreements, detailed supply chain specifics and contract manufacturer identities are not publicly accessible.)
