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List of Drug Master Files (DMF) of DSSTox_CID_3109 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Product

DSSTox_CID_3109
USDMF

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DSSTox_CID_3109

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

47 API Suppliers, 23 USDMF, 9 CEP/COS, 2 JDMF, 6 EU WC, 5 KDMF, 20 NDC API, 30 Listed Suppliers, $ API Reference Price

47 API Suppliers
23 USDMF
9 CEP/COS
2 JDMF
6 EU WC
5 KDMF
20 NDC API
30 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

32 Drugs in Development

32 Drugs in Development

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

FINISHED DOSAGE FORMULATIONS

144 FDF Dossiers, 83 FDA Orange Book, 22 Europe, 13 Canada, 1 Australia, 7 South Africa, 18 Listed Dossiers

144 FDF Dossiers
83 FDA Orange Book
22 Europe
13 Canada
1 Australia
7 South Africa
18 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 1MG, TABLET;ORAL - 2MG, INJECTABLE;INJECTION - 0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, POWDER;INHALATION - 15.6MCG/INH, POWDER;INHALATION - 15.6MCG/INH;27.5MCG/INH, SOLUTION;INHALATION - 25MCG/ML, TABLET, ORALLY DISINTEGRATING;ORAL - 1.7MG

TABLET;ORAL - 1MG
TABLET;ORAL - 2MG
INJECTABLE;INJECTION - 0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
POWDER;INHALATION - 15.6MCG/INH
POWDER;INHALATION - 15.6MCG/INH;27.5MCG/INH
SOLUTION;INHALATION - 25MCG/ML
TABLET, ORALLY DISINTEGRATING;ORAL - 1.7MG

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 6 SPI Pharma, 1 DKSH, 1 Nippon Fine Chemical, 4 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 8 Actylis, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 10 BASF, 6 DFE Pharma, 3 Finar, 5 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 27 Kerry, 12 Microlex e.U, 1 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 26 Roquette, 1 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

72 Fillers, Diluents & Binders, 33 Direct Compression, 20 Disintegrants & Superdisintegrants, 19 Co-Processed Excipients, 16 Granulation, 15 Thickeners and Stabilizers, 15 Parenteral, 14 Film Formers & Plasticizers, 12 Lubricants & Glidants, 11 Taste Masking, 11 Solubilizers, 10 Controlled & Modified Release, 10 Coating Systems & Additives, 7 Chewable & Orodispersible Aids, 6 Topical, 3 Emulsifying Agents, 1 Rheology Modifiers, 1 Dry Powder Inhalation, 1 Soft Gelatin, 1 API Stability Enhancers, 1 Surfactant & Foaming Agents

72 Fillers, Diluents & Binders
33 Direct Compression
20 Disintegrants & Superdisintegrants
19 Co-Processed Excipients
16 Granulation
15 Thickeners and Stabilizers
15 Parenteral
14 Film Formers & Plasticizers
12 Lubricants & Glidants
11 Taste Masking
11 Solubilizers
10 Controlled & Modified Release
10 Coating Systems & Additives
7 Chewable & Orodispersible Aids
6 Topical
3 Emulsifying Agents
1 Rheology Modifiers
1 Dry Powder Inhalation
1 Soft Gelatin
1 API Stability Enhancers
1 Surfactant & Foaming Agents

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 1 STOCK RECAP #PipelineProspector, 112 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
1 STOCK RECAP #PipelineProspector
112 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 27 Finished Drug Prices, 25 Annual Reports

1 US Medicaid Prescriptions
27 Finished Drug Prices
25 Annual Reports

MARKET PLACE

23 APIs, 1 FDF Dossiers

23 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

32 US Patents, 4 Health Canada Patents

32 US Patents
4 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 5 USP, 11 Others

3 EDQM
5 USP
11 Others

$ API Ref.Price (USD/KG) : 26,220 Xls

Filters

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Filters

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23 All

01 1Inke S.A

02 1Seqens

03 1AKSHAT PHARMA PRIVATE LTD

04 1Amsa Spa

05 1Aurobindo Pharma Limited

06 1BIOFIRST PHARMACEUTICALS LLC

07 1Boehringer Ingelheim GmbH

08 1Breathgreen Pharmaceuticals

09 1CSL Vifor

10 1Endo International

11 1Hainan Poly Pharm

12 1Harman Finochem

13 1Hikma Pharmaceuticals

14 1Hovione

15 1Melody Healthcare Pvt Ltd

16 1Nishchem International Pvt. Ltd

17 1Resonance Laboratories Pvt. Ltd

18 1Siegfried AG

19 1Sifavitor srl

20 1Suven Life Sciences Limited

21 1Swati Spentose

22 1Tai Heng Industry Co., Ltd

23 1Viyash Life Sciences

filter Subject Reset all filters

23 All

01 9GLYCOPYRROLATE

02 1GLYCOPYRROLATE INHALATION GRADE

03 9GLYCOPYRROLATE USP

04 1GLYCOPYRROLATE USP, NON-STERILE DRUG SUBSTANCE

05 1GLYCOPYRRONIUM BROMIDE

06 1GLYCOPYRRONIUM BROMIDE (MICRONIZED AND NON-MICRONIZED)

07 1VIT-45 POWDER

filter Country Reset all filters

23 All

01 2China

02 1France

03 1Germany

04 9India

05 1Ireland

06 2Italy

07 1Portugal

08 1Spain

09 2Switzerland

10 2U.S.A

11 1United Kingdom

filter Status Reset all filters

23 All

01 18Active

02 5Inactive

filter GDUFA DMF Review Reset all filters

23 All

01 8Complete

02 15Blank

Inke Glycopyrronium 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

Glycopyrrolate

GDUFA

DMF Review : Complete

Rev. Date : 2018-02-16

Pay. Date : 2017-07-06

DMF Number : 31836

Submission : 2017-07-22

Status : Active

Type : II

Inke Company Banner

Product Web Link

Digital Content

02

Pcas

CPhI Worldwide, Milan

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

Contact Supplier

Contact Supplier

Digital Content

Glycopyrrolate

GDUFA

DMF Review : Complete

Rev. Date : 2013-10-05

Pay. Date : 2013-09-30

DMF Number : 18106

Submission : 2005-02-22

Status : Active

Type : II

Seqens Company Banner

Product Web Link

Digital Content

03

Akshat Pharma Private Ltd

India

USDMF

Formnext Forum

Not Confirmed

03

Akshat Pharma Private Ltd

India

Formnext Forum

Not Confirmed

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India

Digital Content

Glycopyrrolate Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 19026

Submission : 2005-12-10

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Website

Corporate PDF

04

Amsa Spa

USDMF

Formnext Forum

Not Confirmed

04

Amsa Spa

Formnext Forum

Not Confirmed

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Digital Content

Glycopyrrolate

GDUFA

DMF Review : Complete

Rev. Date : 2015-03-13

Pay. Date : 2015-03-06

DMF Number : 16972

Submission : 2003-11-13

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Vifor International Inc

USDMF

Formnext Forum

Not Confirmed

05

Vifor International Inc

Formnext Forum

Not Confirmed

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Digital Content

Vit-45 Powder

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 16967

Submission : 2003-11-17

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Harman Finochem Ltd

USDMF

Formnext Forum

Not Confirmed

06

Harman Finochem Ltd

Formnext Forum

Not Confirmed

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Digital Content

Glycopyrrolate Usp

GDUFA

DMF Review : Complete

Rev. Date : 2012-11-23

Pay. Date : 2012-12-06

DMF Number : 19710

Submission : 2006-08-28

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

07

Hikma Pharmaceuticals Llc

USDMF

Formnext Forum

Not Confirmed

07

Hikma Pharmaceuticals Llc

Formnext Forum

Not Confirmed

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Digital Content

Glycopyrrolate Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 18727

Submission : 2005-08-31

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Resonance Laboratories Pvt Ltd

USDMF

Formnext Forum

Not Confirmed

08

Resonance Laboratories Pvt Ltd

Formnext Forum

Not Confirmed

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Digital Content

Glycopyrrolate

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 26470

Submission : 2012-09-17

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Olon Spa

USDMF

Formnext Forum

Not Confirmed

09

Olon Spa

Formnext Forum

Not Confirmed

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Digital Content

Glycopyrronium Bromide

GDUFA

DMF Review : Complete

Rev. Date : 2018-08-27

Pay. Date : 2018-04-24

DMF Number : 29990

Submission : 2015-11-03

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Tai Heng Industry Co Ltd

USDMF

Formnext Forum

Not Confirmed

10

Tai Heng Industry Co Ltd

Formnext Forum

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

Glycopyrrolate Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 21326

Submission : 2008-02-07

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

1
2
3

DSSTox_CID_3109 Manufacturers | Traders | Suppliers

DSSTox_CID_3109 Manufacturers, Traders, Suppliers 1

39

We have 23 companies offering DSSTox_CID_3109

Get in contact with the supplier of your choice:

Inke S.A
Seqens
AKSHAT PHARMA PRIVATE LTD
Amsa Spa
Aurobindo Pharma Limited
BIOFIRST PHARMACEUTICALS LLC
Boehringer Ingelheim GmbH
Breathgreen Pharmaceuticals
CSL Vifor
Endo International
Hainan Poly Pharm
Harman Finochem
Hikma Pharmaceuticals
Hovione
Melody Healthcare Pvt Ltd
Nishchem International Pvt. Ltd
Resonance Laboratories Pvt. Ltd
Siegfried AG
Sifavitor srl
Suven Life Sciences Limited
Swati Spentose
Tai Heng Industry Co., Ltd
Viyash Life Sciences

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