Leflunomide | API DMFs | US Drug Master File (DMF) Details | Pharmacompass.com

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Leflunomide
USDMF

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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xyz-pharma-m-2024-10-07

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With Fermion, start the journey of your innovative API.

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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xyz-pharma-m-2024-10-07

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Leflunomide

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

17 API Suppliers, 6 USDMF, 5 CEP/COS, 3 EU WC, 3 KDMF, 8 NDC API, 15 Listed Suppliers, $ API Reference Price

17 API Suppliers
6 USDMF
5 CEP/COS
3 EU WC
3 KDMF
8 NDC API
15 Listed Suppliers
$ API Reference Price

INTERMEDIATES

4 Intermediates Suppliers

4 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

231 FDF Dossiers, 27 FDA Orange Book, 92 Europe, 18 Canada, 56 Australia, 7 South Africa, 31 Listed Dossiers

231 FDF Dossiers
27 FDA Orange Book
92 Europe
18 Canada
56 Australia
7 South Africa
31 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG, TABLET;ORAL - 10MG, TABLET;ORAL - 20MG

TABLET;ORAL - 100MG
TABLET;ORAL - 10MG
TABLET;ORAL - 20MG

RELATED EXCIPIENT COMPANIES

3 SPI Pharma, 2 Seqens, 3 DKSH, 5 Faran Shimi Pharmaceutical, 5 Boai NKY Pharmaceuticals Ltd, 10 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 23 BASF, 10 Corel Pharma Chem, 4 DFE Pharma, 1 Finar, 11 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 34 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 9 Roquette, 13 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 5 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

59 Fillers, Diluents & Binders, 43 Coating Systems & Additives, 31 Direct Compression, 28 Disintegrants & Superdisintegrants, 25 Controlled & Modified Release, 23 Solubilizers, 20 Granulation, 14 Thickeners and Stabilizers, 14 Co-Processed Excipients, 12 Lubricants & Glidants, 10 Topical, 10 Parenteral, 10 Film Formers & Plasticizers, 8 Chewable & Orodispersible Aids, 7 Emulsifying Agents, 6 Taste Masking, 5 Empty Capsules, 5 API Stability Enhancers, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Rheology Modifiers, 2 Surfactant & Foaming Agents

59 Fillers, Diluents & Binders
43 Coating Systems & Additives
31 Direct Compression
28 Disintegrants & Superdisintegrants
25 Controlled & Modified Release
23 Solubilizers
20 Granulation
14 Thickeners and Stabilizers
14 Co-Processed Excipients
12 Lubricants & Glidants
10 Topical
10 Parenteral
10 Film Formers & Plasticizers
8 Chewable & Orodispersible Aids
7 Emulsifying Agents
6 Taste Masking
5 Empty Capsules
5 API Stability Enhancers
4 Vegetarian Capsules
4 Coloring Agents
3 Rheology Modifiers
2 Surfactant & Foaming Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 7 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
7 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 75 Finished Drug Prices

2 US Medicaid Prescriptions
75 Finished Drug Prices

MARKET PLACE

19 APIs, 2 FDF Dossiers

19 APIs
2 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 4 USP, 7 Others

3 EDQM
4 USP
7 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 1,046 Xls

Filters

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6 All

01 1Alembic Pharmaceuticals Limited

02 1Cipla

03 1Emcure Pharmaceuticals

04 1Formosa Laboratories

05 1Maprimed

06 1Unichem Laboratories Limited

filter Subject Reset all filters

6 All

01 3LEFLUNOMIDE

02 3LEFLUNOMIDE USP

filter Country Reset all filters

6 All

01 1Argentina

02 4India

03 1Taiwan

filter Status Reset all filters

6 All

01 5Active

02 1Inactive

filter GDUFA DMF Review Reset all filters

6 All

01 3Complete

02 3Blank

List of Suppliers

Product Main Page

01

Alembic Pharmaceuticals Ltd

USDMF

Antibody Engineering

Not Confirmed

01

Alembic Pharmaceuticals Ltd

Antibody Engineering

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

Leflunomide Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 16112

Submission : 2002-08-29

Status : Active

Type : II

Product Web Link

Digital Content

02

Cipla Ltd

USDMF

Antibody Engineering

Not Confirmed

02

Cipla Ltd

Antibody Engineering

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

Leflunomide Usp

GDUFA

DMF Review : Complete

Rev. Date : 2016-02-18

Pay. Date : 2015-08-21

DMF Number : 16109

Submission : 2002-08-23

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Emcure Pharmaceuticals Ltd

USDMF

Antibody Engineering

Not Confirmed

03

Emcure Pharmaceuticals Ltd

Antibody Engineering

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

Leflunomide Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 16124

Submission : 2002-09-06

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

04

Formosa Laboratories Inc

USDMF

Antibody Engineering

Not Confirmed

04

Formosa Laboratories Inc

Antibody Engineering

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

Leflunomide

GDUFA

DMF Review : Complete

Rev. Date : 2013-03-07

Pay. Date : 2016-08-04

DMF Number : 16038

Submission : 2002-06-27

Status : Active

Type : II

Product Web Link

Digital Content

05

Maprimed Sa

USDMF

Antibody Engineering

Not Confirmed

05

Maprimed Sa

Antibody Engineering

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

Leflunomide

GDUFA

DMF Review : Complete

Rev. Date : 2018-12-16

Pay. Date : 2018-09-04

DMF Number : 32988

Submission : 2018-09-07

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Unichem Laboratories Ltd

USDMF

Antibody Engineering

Not Confirmed

06

Unichem Laboratories Ltd

Antibody Engineering

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

Leflunomide

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 16504

Submission : 2003-03-25

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

Leflunomide Manufacturers | Traders | Suppliers

Leflunomide Manufacturers, Traders, Suppliers 1

94

We have 6 companies offering Leflunomide

Get in contact with the supplier of your choice:

Alembic Pharmaceuticals Limited
Cipla
Emcure Pharmaceuticals
Formosa Laboratories
Maprimed
Unichem Laboratories Limited

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