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

Client Email

Product

Diphenoxylate
Atropine Sulfate
USDMF

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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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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Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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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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Diphenoxylate

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

10 API Suppliers, 6 USDMF, 1 CEP/COS, 2 EU WC, 5 NDC API, 4 Listed Suppliers, $ API Reference Price

10 API Suppliers
6 USDMF
1 CEP/COS
2 EU WC
5 NDC API
4 Listed Suppliers
$ API Reference Price

PRICE INFORMATION

API Reference Price, API Exports

API Reference Price
API Exports

INTERMEDIATES

1 API Suppliers

1 API Suppliers

FINISHED DOSAGE FORMULATIONS

44 FDF Dossiers, 39 FDA Orange Book, 1 Canada, 2 South Africa, 2 Listed Dossiers

44 FDF Dossiers
39 FDA Orange Book
1 Canada
2 South Africa
2 Listed Dossiers

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 6 SPI Pharma, 1 DKSH, 12 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Actylis, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 BASF, 5 DFE Pharma, 6 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 19 Kerry, 13 Microlex e.U, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 26 Roquette, 1 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

2 Rochem International Inc
6 SPI Pharma
1 DKSH
12 Gangwal Healthcare
2 Nanjing Well Pharmaceutical
1 Pfanstiehl
3 Actylis
1 Aeon Procare
5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
2 BASF
5 DFE Pharma
6 Gangwal Chemicals
1 Ideal Cures Pvt Ltd
3 Ingredion Pharma Solutions
19 Kerry
13 Microlex e.U
2 Pharmatrans-Sanaq
4 Pluviaendo
3 Prachin Chemical
26 Roquette
1 Seppic
4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
11 Sigachi Industries
4 Vasa Pharmachem
1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

57 Fillers, Diluents & Binders, 26 Direct Compression, 21 Lubricants & Glidants, 18 Disintegrants & Superdisintegrants, 16 Thickeners and Stabilizers, 14 Co-Processed Excipients, 12 Film Formers & Plasticizers, 11 Coating Systems & Additives, 11 Taste Masking, 11 Granulation, 7 Controlled & Modified Release, 7 Chewable & Orodispersible Aids, 7 Parenteral, 4 Emulsifying Agents, 2 API Stability Enhancers, 2 Topical, 1 Rheology Modifiers, 1 Soft Gelatin

57 Fillers, Diluents & Binders
26 Direct Compression
21 Lubricants & Glidants
18 Disintegrants & Superdisintegrants
16 Thickeners and Stabilizers
14 Co-Processed Excipients
12 Film Formers & Plasticizers
11 Coating Systems & Additives
11 Taste Masking
11 Granulation
7 Controlled & Modified Release
7 Chewable & Orodispersible Aids
7 Parenteral
4 Emulsifying Agents
2 API Stability Enhancers
2 Topical
1 Rheology Modifiers
1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 8 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
8 NEWS #PharmaBuzz

MARKET PLACE

5 APIs

5 APIs

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 5 Others

3 EDQM
1 USP
5 Others

$ API Ref.Price (USD/KG) : 548 Xls

Filters

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Filters

FILTER :

filter Holder Reset all filters

6 All

01 1Veranova

02 1Mallinckrodt Pharmaceuticals

03 2Siegfried AG

04 1Viatris

05 1Blank

filter Subject Reset all filters

6 All

01 1DIPHENOXYLATE HCL

02 1DIPHENOXYLATE HCL W/1% ATROPINE SULFATE SUBSTANCE

03 2DIPHENOXYLATE HYDROCHLORIDE USP

04 1DIPHENOXYLATE HYDROCHLORIDE USP BULK

05 1DIPHENOXYLATE HYDROCHLORIDE USP WITH 1% ATROPINE SULFATE USP BULK

filter Country Reset all filters

6 All

01 1Ireland

02 2Switzerland

03 2U.S.A

04 1Blank

filter Status Reset all filters

6 All

01 3Active

02 3Inactive

filter GDUFA DMF Review Reset all filters

6 All

01 2Complete

02 4Blank

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

List of Suppliers

Product Main Page

01

Veranova Lp

CPhI Worldwide, Milan

Veranova: A CDMO that manages complexity with confidence.

Contact Supplier

Contact Supplier

Digital Content

Diphenoxylate Hcl

GDUFA

DMF Review : Complete

Rev. Date : 2015-09-03

Pay. Date : 2013-11-19

DMF Number : 27700

Submission : 2014-01-20

Status : Active

Type : II

Product Web Link

Digital Content

02

Specgx Llc

USDMF

Luxepack

Not Confirmed

02

Specgx Llc

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

Diphenoxylate Hydrochloride Usp

GDUFA

DMF Review : Complete

Rev. Date : 2014-05-22

Pay. Date : 2014-03-05

DMF Number : 12441

Submission : 1997-03-31

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Sb Penick And Co

USDMF

Luxepack

Not Confirmed

03

Sb Penick And Co

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

Diphenoxylate Hydrochloride Usp With 1% Atropi...

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 2973

Submission : 1977-07-01

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

04

Sb Penick And Co

USDMF

Luxepack

Not Confirmed

04

Sb Penick And Co

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

Diphenoxylate Hydrochloride Usp Bulk

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 2965

Submission : 1977-06-29

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

05

Tianish Laboratories Private Ltd

USDMF

Luxepack

Not Confirmed

05

Tianish Laboratories Private 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

Diphenoxylate Hydrochloride Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 32296

Submission : 2018-11-30

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Md Pharmaceutical Inc

Country

USDMF

Luxepack

Not Confirmed

06

Md Pharmaceutical Inc

Country

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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Country

Virtual Booth

Digital Content

Diphenoxylate Hcl W/1% Atropine Sulfate Substa...

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 4580

Submission : 1982-06-03

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

Diphenoxylate Manufacturers | Traders | Suppliers

Diphenoxylate Manufacturers, Traders, Suppliers 1

87

We have 4 companies offering Diphenoxylate

Get in contact with the supplier of your choice:

Veranova
Mallinckrodt Pharmaceuticals
Siegfried AG
Viatris

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