Molecules / Tiotropium

Tiotropium API manufacturers

CAS 186691-13-4 ATC R03BB04 Updated 9 July 2026
13
manufacturers with an active filing 12 of them hold a US DMF or a CEP
44
shortage records on file across 5 countries
230
finished-dose makers across 42 regulators
Showing 13 of 13 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Lupin

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

Holds one active US DMF and 2 valid CEPs for tiotropium, filing since 2016. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 30 markets.

US DMF
1 active
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
30 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
02

Vamsi Labs

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

Holds 2 active US DMFs and one valid CEP for tiotropium, filing since 2020. Its 2018 FDA inspection closed as VAI.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2018 · VAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
03

Industriale Chimica

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

Holds one active US DMF and one valid CEP for tiotropium, filing since 2013. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
04

Boehringer Ingelheim Pharma Gmbh

Germany
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for tiotropium. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 42 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
42 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
06

Cerbios-Pharma

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

Holds 2 active US DMFs for tiotropium, filing since 2015. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Wavelength Enterprises

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

Holds 4 active US DMFs for tiotropium, filing since 2013. Its 2022 FDA inspection closed as NAI.

US DMF
4 active
CEP
None on file
Last FDA inspection
2022 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Cipla

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

Holds 4 valid CEPs for tiotropium, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
None on file
CEP
4 valid
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
How this listing is sourced EDQM certificate database
View profile
09

Kyongbo Pharmaceutical

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

Holds one valid CEP for tiotropium, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
View profile
10

Inke

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

Holds 2 active US DMFs for tiotropium, filing since 2020. 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
11
Credentials confirmed against the regulator files on 25 July 2026

Holds one valid CEP for tiotropium, filing since 2025. Its GMP is recognised in 3 markets.

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

10 more manufacturers hold filings for tiotropium

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

Boehringer Ingelheim Pharma GmbhBreathgreen PharmaceuticalCerbios-PharmaWavelength EnterprisesCiplaKyongbo PharmaceuticalInkeDEVA HOLDİNG A.Ş. (2020/3) (Hammadde)zhejiang xianju pharmaceuticalShandong Risen-Sun Pharmaceutical
Open the full list with a free account

Contract manufacturers (2)

Hovione Farmaciência Portugal Inke Spain

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

Finished-dose makers (11)

Glenmark Pharmaceuticals s.r.o Czech Republic Zentiva, k.s Czech Republic Viatris United States Apotex Canada STADA Arzneimittel Germany Boehringer Ingelheim Animal Health Usa United States Laboratorios Liconsa Spain Pt Tunggal Idaman Abdi Indonesia Zaklady Farmaceutyczne Polpharma Poland Eg S P A Italy 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

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Also on this molecule

Shortages 44 Recalls 2 Finished dose 11 Contract mfrs 2

By country

China 6