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List of Drug Master Files (DMF) of Tiotropium Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email

Product

Tiotropium
CAS 26447-85-8
USDMF

PharmaCompass Sponsored Ads

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Bora Pharmaceuticals- Making success more certain.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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PharmaCompass Sponsored Ads

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Axplora- The partner of choice for complex APIs.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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Tiotropium

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

38 API Suppliers, 10 USDMF, 10 CEP/COS, 1 JDMF, 4 EU WC, 1 KDMF, 8 NDC API, 28 Listed Suppliers, $ API Reference Price

38 API Suppliers
10 USDMF
10 CEP/COS
1 JDMF
4 EU WC
1 KDMF
8 NDC API
28 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

10 Drugs in Development

10 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports

API Reference Price
API Exports
API Imports
FDF Exports

INTERMEDIATES

5 API Suppliers

5 API Suppliers

FINISHED DOSAGE FORMULATIONS

102 FDF Dossiers, 6 FDA Orange Book, 74 Europe, 5 Australia, 8 South Africa, 9 Listed Dossiers

102 FDF Dossiers
6 FDA Orange Book
74 Europe
5 Australia
8 South Africa
9 Listed Dossiers

RELATED EXCIPIENT COMPANIES

3 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 2 DFE Pharma, 14 Kerry, 2 Microlex e.U, 1 Pluviaendo, 2 Sigachi Industries

3 Gangwal Healthcare
1 Nanjing Well Pharmaceutical
2 DFE Pharma
14 Kerry
2 Microlex e.U
1 Pluviaendo
2 Sigachi Industries

EXCIPIENTS BY APPLICATIONS

20 Fillers, Diluents & Binders, 7 Direct Compression, 4 Granulation, 4 Co-Processed Excipients, 1 Parenteral

20 Fillers, Diluents & Binders
7 Direct Compression
4 Granulation
4 Co-Processed Excipients
1 Parenteral

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 58 NEWS #PharmaBuzz

3 DATA COMPILATION #PharmaFlow
58 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 39 Finished Drug Prices, 8 Annual Reports

1 US Medicaid Prescriptions
39 Finished Drug Prices
8 Annual Reports

MARKET PLACE

10 APIs, 1 FDF Dossiers

10 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

41 US Patents, 8 Health Canada Patents

41 US Patents
8 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 8 Others

4 EDQM
8 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 189,034 Xls

Filters

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10 All

01 1Inke S.A

02 1Vamsi Labs

03 1Seqens

04 2Boehringer Ingelheim GmbH

05 2Cerbios-Pharma SA

06 1Industriale Chimica

07 1Lupin Ltd

08 1Teva API

filter Subject Reset all filters

10 All

01 1TIOTROPIUM BROMIDE MONOHYDRATE

02 3TIOTROPIUM BROMIDE

03 5TIOTROPIUM BROMIDE MONOHYDRATE

04 1TIOTROPIUM BROMIDE MONOHYDRATE (MICRONIZED AND NON-MICRONIZED)

filter Country Reset all filters

10 All

01 1France

02 2Germany

03 2India

04 1Israel

05 1Italy

06 1Spain

07 2Switzerland

filter Status Reset all filters

10 All

01 8Active

02 2Inactive

filter GDUFA DMF Review Reset all filters

10 All

01 7Complete

02 3Blank

Inke Tiotropium Bromide

API Suppliers
USDMF
CEP/COS
JDMF
EU WC
KDMF
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Inke Sa

CPhI Worldwide, Milan

Inke S.A: APIs manufacturing plant.

Contact Supplier

Contact Supplier

Digital Content

Tiotropium Bromide Monohydrate (micronized And...

GDUFA

DMF Review : Complete

Rev. Date : 2021-04-30

Pay. Date : 2020-01-13

DMF Number : 34410

Submission : 2020-03-17

Status : Active

Type : II

Inke Company Banner

Product Web Link

Digital Content

02

Vamsi Labs Ltd

CPhI Worldwide, Milan

Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.

Contact Supplier

Contact Supplier

Digital Content

Tiotropium Bromide Monohydrate

GDUFA

DMF Review : Complete

Rev. Date : 2021-01-11

Pay. Date : 2020-11-04

DMF Number : 34808

Submission : 2020-04-15

Status : Active

Type : II

Product Web Link

Digital Content

03

Wavelength Enterprises Ltd

CPhI Worldwide, Milan

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

Contact Supplier

Contact Supplier

Digital Content

Tiotropium Bromide Monohydrate

GDUFA

DMF Review : Complete

Rev. Date : 2015-01-16

Pay. Date : 2013-12-31

DMF Number : 28161

Submission : 2013-12-26

Status : Active

Type : II

Seqens Company Banner

Product Web Link

Digital Content

04

Boehringer Ingelheim Pharma Gmbh And...

USDMF

Luxepack

Not Confirmed

04

Boehringer Ingelheim Pharma Gmbh And...

Luxepack

Not Confirmed

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Digital Content

Tiotropium Bromide Monohydrate

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 21939

Submission : 2008-09-05

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Boehringer Ingelheim Pharma Gmbh And...

USDMF

Luxepack

Not Confirmed

05

Boehringer Ingelheim Pharma Gmbh And...

Luxepack

Not Confirmed

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Digital Content

Tiotropium Bromide Monohydrate

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 18135

Submission : 2005-03-03

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Cerbios Pharma Sa

USDMF

Luxepack

Not Confirmed

06

Cerbios Pharma Sa

Luxepack

Not Confirmed

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Digital Content

Tiotropium Bromide

GDUFA

DMF Review : Complete

Rev. Date : 2015-09-03

Pay. Date : 2015-02-05

DMF Number : 28820

Submission : 2015-01-27

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

07

Cerbios Pharma Sa

USDMF

Luxepack

Not Confirmed

07

Cerbios Pharma Sa

Luxepack

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Tiotropium Bromide Monohydrate

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 36281

Submission : 2021-10-01

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

08

Industriale Chimica Srl

USDMF

Luxepack

Not Confirmed

08

Industriale Chimica Srl

Luxepack

Not Confirmed

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Digital Content

Tiotropium Bromide

GDUFA

DMF Review : Complete

Rev. Date : 2023-12-07

Pay. Date : 2023-07-27

DMF Number : 27120

Submission : 2013-04-30

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Lupin Ltd

USDMF

Luxepack

Not Confirmed

09

Lupin Ltd

Luxepack

Not Confirmed

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Digital Content

Tiotropium Bromide Monohydrate

GDUFA

DMF Review : Complete

Rev. Date : 2016-04-20

Pay. Date : 2015-11-19

DMF Number : 29726

Submission : 2016-01-20

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

10

Teva Pharmaceutical Industries Ltd

USDMF

Luxepack

Not Confirmed

10

Teva Pharmaceutical Industries Ltd

Luxepack

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Tiotropium Bromide

GDUFA

DMF Review : Complete

Rev. Date : 2014-03-15

Pay. Date : 2013-09-17

DMF Number : 27524

Submission : 2013-10-23

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

Tiotropium Manufacturers | Traders | Suppliers

Tiotropium Manufacturers, Traders, Suppliers 1

51

We have 8 companies offering Tiotropium

Get in contact with the supplier of your choice:

Inke S.A
Seqens
Vamsi Labs
Boehringer Ingelheim GmbH
Cerbios-Pharma SA
Industriale Chimica
Lupin Ltd
Teva API

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