Molecules / Tolterodine

Tolterodine API manufacturers

CAS 124937-51-5 ATC G04BD07 · Urinary antispasmodics Updated 9 July 2026
11
manufacturers with an active filing 11 of them hold a US DMF or a CEP
64
shortage records on file across 5 countries
189
finished-dose makers across 27 regulators
Showing 11 of 11 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Macleods Pharmaceuticals

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 tolterodine, filing since 2010. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
1 active
CEP
2 valid
Last FDA inspection
2024 · VAI
GMP recognised in
29 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
02

Dr. Reddy's Laboratories

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

Holds one active US DMF for tolterodine, filing since 2004. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

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

Maithri Drugs

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

Holds 2 active US DMFs and one valid CEP for tolterodine, filing since 2020. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

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

Hetero

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

Holds 2 active US DMFs for tolterodine, filing since 2009. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

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

Alkem Laboratories

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

Holds one active US DMF for tolterodine, filing since 2016. Its GMP is recognised in 21 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
21 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Cipla

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

Holds one active US DMF for tolterodine, filing since 2003. 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
07

Orchid Pharma

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

Holds one active US DMF for tolterodine, filing since 2010. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
3 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Erregierre

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

Holds one active US DMF for tolterodine, filing since 2007. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Apitoria Pharma

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

Holds one active US DMF and one valid CEP for tolterodine, filing since 2006. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Interquim

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

Holds one active US DMF for tolterodine, filing since 2006. Its 2024 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Amino Chemicals

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

Holds one active US DMF for tolterodine, filing since 2006. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 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

8 more manufacturers hold filings for tolterodine

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

HeteroAlkem LaboratoriesCiplaOrchid PharmaErregierreApitoria PharmaInterquimAmino Chemicals
Open the full list with a free account

Contract manufacturers (3)

Harman Finochem India Erregierre Italy Polpharma Group Poland

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

Finished-dose makers (25)

Viatris United States Ajanta Pharma India Apotex Canada Teva Israel Zentiva, k.s Czech Republic ANI Pharmaceuticals United States Rising United States Rivopharm Switzerland Sandoz Switzerland Pharmathen Greece Jamp Pharma Canada Mint Pharmaceuticals Canada Pfizer United States Pfizer Brasil Ltda Brazil Pfizer Italia Italy Unichem Laboratories India Laboratorios Cinfa S A Spain Laboratorios Normon Spain STADA Arzneimittel Germany Casen Recordati, S.L Spain

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 64 Recalls 4 Finished dose 25 Contract mfrs 3

By country

India 13