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

Client Email

Product

Bensedin
USDMF

Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.

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As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

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xyz-pharma-m-2024-10-07

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Evonik

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Gensenta is a trusted CDMO partner with robust history, commitment to quality, innovative mindset and commitment to sustainability.

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xyz-pharma-m-2024-10-07

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Bensedin

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

17 API Suppliers, 7 USDMF, 4 CEP/COS, 2 JDMF, 3 EU WC, 9 NDC API, 13 Listed Suppliers, $ API Reference Price

17 API Suppliers
7 USDMF
4 CEP/COS
2 JDMF
3 EU WC
9 NDC API
13 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

33 Drugs in Development

33 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

INTERMEDIATES

1 API Suppliers

1 API Suppliers

FINISHED DOSAGE FORMULATIONS

357 FDF Dossiers, 127 FDA Orange Book, 129 Europe, 15 Canada, 31 Australia, 18 South Africa, 37 Listed Dossiers

357 FDF Dossiers
127 FDA Orange Book
129 Europe
15 Canada
31 Australia
18 South Africa
37 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 2MG, TABLET;ORAL - 5MG, GEL;RECTAL - 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;RECTAL - 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;RECTAL - 2.5MG/0.5ML (5MG/ML), GEL;RECTAL - 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;RECTAL - 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 10MG
TABLET;ORAL - 2MG
TABLET;ORAL - 5MG
GEL;RECTAL - 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
GEL;RECTAL - 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
GEL;RECTAL - 2.5MG/0.5ML (5MG/ML)
GEL;RECTAL - 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
GEL;RECTAL - 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 1 DKSH, 1 Jai Radhe Sales, 13 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 4 Actylis, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 14 BASF, 2 Clariant, 10 Corel Pharma Chem, 7 DFE Pharma, 3 Finar, 6 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 36 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 27 Roquette, 7 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 5 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

65 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 30 Direct Compression, 28 Disintegrants & Superdisintegrants, 26 Controlled & Modified Release, 20 Thickeners and Stabilizers, 19 Lubricants & Glidants, 19 Granulation, 18 Film Formers & Plasticizers, 16 Topical, 15 Co-Processed Excipients, 13 Taste Masking, 9 Parenteral, 9 Solubilizers, 8 Chewable & Orodispersible Aids, 6 Emulsifying Agents, 5 Empty Capsules, 4 Rheology Modifiers, 4 Vegetarian Capsules, 4 API Stability Enhancers, 2 Surfactant & Foaming Agents, 2 Coloring Agents, 1 Soft Gelatin

65 Fillers, Diluents & Binders
47 Coating Systems & Additives
30 Direct Compression
28 Disintegrants & Superdisintegrants
26 Controlled & Modified Release
20 Thickeners and Stabilizers
19 Lubricants & Glidants
19 Granulation
18 Film Formers & Plasticizers
16 Topical
15 Co-Processed Excipients
13 Taste Masking
9 Parenteral
9 Solubilizers
8 Chewable & Orodispersible Aids
6 Emulsifying Agents
5 Empty Capsules
4 Rheology Modifiers
4 Vegetarian Capsules
4 API Stability Enhancers
2 Surfactant & Foaming Agents
2 Coloring Agents
1 Soft Gelatin

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 68 NEWS #PharmaBuzz

3 DATA COMPILATION #PharmaFlow
68 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 136 Finished Drug Prices, 3 Annual Reports

4 US Medicaid Prescriptions
136 Finished Drug Prices
3 Annual Reports

MARKET PLACE

29 APIs, 24 FDF Dossiers

29 APIs
24 FDF Dossiers

PATENTS & EXCLUSIVITIES

23 US Patents, 8 US Exclusivities, 1 Health Canada Patents

23 US Patents
8 US Exclusivities
1 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 2 USP, 10 Others

2 EDQM
2 USP
10 Others

$ API Ref.Price (USD/KG) : 223 Xls

Filters

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7 All

01 1Cambrex Corporation

02 1Centaur Pharmaceuticals

03 1F.I.S. Fabbrica Italiana Sintetici

04 1FDC

05 1Gedeon Richter

06 1Navinta

07 1R L Fine Chem

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7 All

01 3DIAZEPAM

02 1DIAZEPAM U.S.P. XXI

03 3DIAZEPAM USP

filter Country Reset all filters

7 All

01 1Hungary

02 3India

03 1Italy

04 2U.S.A

filter Status Reset all filters

7 All

01 5Active

02 2Inactive

filter GDUFA DMF Review Reset all filters

7 All

01 5Complete

02 2Blank

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

List of Suppliers

Product Main Page

01

Cambrex Profarmaco Milano Srl

USDMF

The Battery Show

Not Confirmed

01

Cambrex Profarmaco Milano Srl

The Battery Show

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

GDUFA

DMF Review : Complete

Rev. Date : 2018-07-13

Pay. Date : 2018-06-20

DMF Number : 1478

Submission : 1970-02-03

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Centaur Pharmaceuticals Private Ltd

USDMF

The Battery Show

Not Confirmed

02

Centaur Pharmaceuticals Private Ltd

The Battery Show

Not Confirmed

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Digital Content

Diazepam Usp

GDUFA

DMF Review : Complete

Rev. Date : 2021-07-08

Pay. Date : 2021-07-06

DMF Number : 21860

Submission : 2008-07-24

Status : Active

Type : II

Product Web Link

Digital Content

03

Fis Fabbrica Italiana Sintetici Spa

USDMF

The Battery Show

Not Confirmed

03

Fis Fabbrica Italiana Sintetici Spa

The Battery Show

Not Confirmed

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Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2012-10-24

Pay. Date : 2013-05-13

DMF Number : 3164

Submission : 1978-02-28

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Fdc Private Ltd

USDMF

The Battery Show

Not Confirmed

04

Fdc Private Ltd

The Battery Show

Not Confirmed

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Digital Content

Diazepam U.s.p. Xxi

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 7025

Submission : 1987-06-18

Status : Inactive

Type : II

Product Web Link

Digital Content

05

Gedeon Richter Ltd

USDMF

The Battery Show

Not Confirmed

05

Gedeon Richter Ltd

The Battery Show

Not Confirmed

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Digital Content

Diazepam Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 6071

Submission : 1985-10-07

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Navinta Llc

USDMF

The Battery Show

Not Confirmed

06

Navinta Llc

The Battery Show

Not Confirmed

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Digital Content

Diazepam Usp

GDUFA

DMF Review : Complete

Rev. Date : 2023-11-14

Pay. Date : 2023-09-26

DMF Number : 38844

Submission : 2023-09-27

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

R L Fine Chem Pvt Ltd

USDMF

The Battery Show

Not Confirmed

07

R L Fine Chem Pvt Ltd

The Battery Show

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

GDUFA

DMF Review : Complete

Rev. Date : 2021-11-24

Pay. Date : 2021-09-20

DMF Number : 33858

Submission : 2019-06-07

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

Bensedin Manufacturers | Traders | Suppliers

Bensedin Manufacturers, Traders, Suppliers 1

18

We have 7 companies offering Bensedin

Get in contact with the supplier of your choice:

Cambrex Corporation
Centaur Pharmaceuticals
F.I.S. Fabbrica Italiana Sintetici
FDC
Gedeon Richter
Navinta
R L Fine Chem

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