Molecules / Vilanterol

Vilanterol API manufacturers

CAS 503068-34-6 Updated 9 July 2026
8
manufacturers with an active filing 8 of them hold a US DMF or a CEP
5
shortage records on file across 3 countries
20
finished-dose makers across 13 regulators
Showing 8 of 8 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Gsk Vaccines

United Kingdom
Makes the APIFinished dose

Its 2026 FDA inspection closed as NAI, and its GMP is recognised in 37 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2026 · NAI
GMP recognised in
37 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Lupin

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for vilanterol, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 30 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
30 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

MSN Laboratories

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

Holds one active US DMF for vilanterol, filing since 2019. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
26 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Cipla

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

Holds one active US DMF for vilanterol, filing since 2024. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Neuland Laboratories

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

Holds 2 active US DMFs for vilanterol, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Melody Healthcare

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

Holds one active US DMF for vilanterol, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Inke

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

Holds 2 active US DMFs for vilanterol, filing since 2023. Its 2023 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Sterling Chemical Malta

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

Holds one active US DMF for vilanterol, filing since 2024. Its 2022 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile

5 more manufacturers hold filings for vilanterol

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

Open the full list with a free account

Contract manufacturers (2)

Contract manufacturers make to order rather than holding their own filing for this molecule.

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

Map vilanterol for your markets

Tell us which markets you need to file in. These suppliers come back tiered for those markets, with the price corridor and an RFI sheet.

Start for free
No sales call.

By country