Molecules / Salmeterol

Salmeterol API manufacturers

CAS 89365-50-4 ATC R03AC12 · Selective beta-2 agonists Updated 9 July 2026
17
manufacturers with an active filing 16 of them hold a US DMF or a CEP
$17000.00
median export price per kg $6415.88 to $59996.41 · 10 exporters · 2022
29
shortage records on file across 8 countries
406
finished-dose makers across 41 regulators
Showing 17 of 17 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Cipla

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

Holds one active US DMF and 4 valid CEPs for salmeterol, filing since 2019. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
1 active
CEP
4 valid
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
03

Natco Pharma

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

Holds 2 active US DMFs and one valid CEP for salmeterol, filing since 2005. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 15 markets.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
15 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
04

Neuland Laboratories

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

Holds 2 active US DMFs and one valid CEP for salmeterol, filing since 2009. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
06

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
08

Amphastar Nanjing Pharmaceuticals

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

Holds one active US DMF for salmeterol, filing since 2015. Its 2025 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Porton Pharma Solutions

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

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

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Aarti Pharmalabs

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

Holds one active US DMF for salmeterol, filing since 2008. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2026 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Fermion Oy

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

Holds one valid CEP for salmeterol, filing since 2024. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
12

Hovione PharmaScience

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

Holds 2 active US DMFs for salmeterol, filing since 2018. Its 2025 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Industriale Chimica

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

Holds one valid CEP for salmeterol, filing since 2025. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
14

Inke

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

Holds 2 active US DMFs for salmeterol, filing since 2010. 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
15

Vamsi Labs

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

Holds one valid CEP for salmeterol, filing since 2025. Its 2018 FDA inspection closed as VAI.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2018 · VAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
16

Gangwal Healthcare

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

Holds one active US DMF for salmeterol, filing since 2013. Its GMP is recognised in 1 market.

US DMF
1 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
17

Glaxo Wellcome Manufacturing Pte

Singapore
Makes the API

Registered with SFDA (Saudi Arabia) for salmeterol.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

14 more manufacturers hold filings for salmeterol

The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.

Neuland LaboratoriesMelody HealthcareGsk VaccinesHovione FarmaciênciaAmphastar Nanjing PharmaceuticalsPorton Pharma SolutionsAarti PharmalabsFermion OyHovione PharmaScienceIndustriale ChimicaInkeVamsi LabsGangwal HealthcareGlaxo Wellcome Manufacturing Pte
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Contract manufacturers (6)

Neuland Laboratories India Coral Drugs India Hovione Farmaciência Portugal Kopran India Gangwal Healthcare India Inke Spain

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

Finished-dose makers (33)

Glenmark Pharmaceuticals s.r.o Czech Republic Viatris United States Zentiva, k.s Czech Republic Lupin India Pharmascience Canada GlaxoSmithKline United States Synthimed Labs India Sandoz Switzerland Orion Finland Glaxo Wellcome Production France Zydus Lifesciences India Beximco Pharmaceuticals Bangladesh Biofarma Turkey Getz Pharma Pakistan STADA Arzneimittel Germany Genetic S. P. A Italy Zaklady Farmaceutyczne Polpharma Poland Elpen Pharmaceutical Greece Teva Israel

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
Price band
Customs export unit values for 2022. These are export values rather than contract prices for regulated-market grade material, which are higher.

Who makes salmeterol?

Ask Fred which manufacturers are on record for salmeterol and what filings they hold.

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Also on this molecule

Price history 1 yrs Shortages 29 Recalls 11 Finished dose 33 Contract mfrs 6

By country

India 8

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