Molecules / Dalbavancin

Dalbavancin API manufacturers

CAS 171500-79-1 ATC J01XA04 Updated 9 July 2026
4
manufacturers with an active filing 4 of them hold a US DMF or a CEP
94
finished-dose makers across 15 regulators
Showing 4 of 4 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dalbavancin, filing since 2021. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
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02

Xellia Pharmaceuticals ApS

Denmark
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dalbavancin, filing since 2024. Its 2021 FDA inspection closed as VAI, and its GMP is recognised in 9 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2021 · VAI
GMP recognised in
9 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

BrightGene Bio-Medical Technology

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for dalbavancin, filing since 2022. Its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Chengdu Yacht Biotechnology

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dalbavancin, filing since 2024.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile

1 more manufacturer holds filings for dalbavancin

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

Chengdu Yacht Biotechnology
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Finished-dose makers (12)

Abbvie United States Fresenius Kabi Ab Sweden Teva Israel Zentiva, k.s Czech Republic BDR Lifesciences India Gufic Biosciences India Virdev Intermediates India Anfarm Hellas Greece Angelini Pharma Italy Laboratorios Reig Jofre Spain Laboratorio Reig Jofre Spain Baxter Healthcare United States

How this list is built

The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators

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Also on this molecule

Finished dose 12 Contract mfrs 0