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List of Drug Master Files (DMF) of MolPort-001-728-041 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email

Product

MolPort-001-728-041
USDMF

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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xyz-pharma-m-2024-09-09

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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xyz-pharma-m-2024-09-09

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MolPort-001-728-041

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

25 API Suppliers, 15 USDMF, 9 CEP/COS, 1 JDMF, 5 EU WC, 3 KDMF, 8 NDC API, 13 Listed Suppliers, $ API Reference Price

25 API Suppliers
15 USDMF
9 CEP/COS
1 JDMF
5 EU WC
3 KDMF
8 NDC API
13 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Imports

INTERMEDIATES

3 API Suppliers

3 API Suppliers

FINISHED DOSAGE FORMULATIONS

198 FDF Dossiers, 55 FDA Orange Book, 60 Europe, 12 Canada, 36 Australia, 9 South Africa, 26 Listed Dossiers

198 FDF Dossiers
55 FDA Orange Book
60 Europe
12 Canada
36 Australia
9 South Africa
26 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG, TABLET;ORAL - 200MG, TABLET;ORAL - 25MG, TABLET;ORAL - 50MG, SUSPENSION;ORAL - 50MG/ML, TABLET, ORALLY DISINTEGRATING;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 100MG
TABLET;ORAL - 200MG
TABLET;ORAL - 25MG
TABLET;ORAL - 50MG
SUSPENSION;ORAL - 50MG/ML
TABLET, ORALLY DISINTEGRATING;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, ORALLY DISINTEGRATING;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, ORALLY DISINTEGRATING;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, ORALLY DISINTEGRATING;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Evonik, 5 Rochem International Inc, 19 SPI Pharma, 3 DKSH, 1 Jai Radhe Sales, 1 Pharm-RX Chemical, 6 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 14 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 15 BASF, 2 Corel Pharma Chem, 6 DFE Pharma, 6 Gangwal Chemicals, 2 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 28 Kerry, 13 Microlex e.U, 1 NEWEDGE Overseas, 1 Novo Excipients, 4 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 28 Roquette, 1 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

88 Fillers, Diluents & Binders, 41 Direct Compression, 24 Disintegrants & Superdisintegrants, 24 Taste Masking, 23 Lubricants & Glidants, 22 Granulation, 21 Thickeners and Stabilizers, 21 Co-Processed Excipients, 20 Chewable & Orodispersible Aids, 17 Coating Systems & Additives, 16 Film Formers & Plasticizers, 14 Controlled & Modified Release, 12 Parenteral, 8 Solubilizers, 5 API Stability Enhancers, 5 Topical, 3 Rheology Modifiers, 3 Emulsifying Agents, 1 Soft Gelatin, 1 Surfactant & Foaming Agents

88 Fillers, Diluents & Binders
41 Direct Compression
24 Disintegrants & Superdisintegrants
24 Taste Masking
23 Lubricants & Glidants
22 Granulation
21 Thickeners and Stabilizers
21 Co-Processed Excipients
20 Chewable & Orodispersible Aids
17 Coating Systems & Additives
16 Film Formers & Plasticizers
14 Controlled & Modified Release
12 Parenteral
8 Solubilizers
5 API Stability Enhancers
5 Topical
3 Rheology Modifiers
3 Emulsifying Agents
1 Soft Gelatin
1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 29 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
29 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 57 Finished Drug Prices

3 US Medicaid Prescriptions
57 Finished Drug Prices

MARKET PLACE

5 APIs, 7 FDF Dossiers, 1 Intermediates

5 APIs
7 FDF Dossiers
1 Intermediates

PATENTS & EXCLUSIVITIES

1 US Patents

1 US Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 2 USP, 7 Others

2 EDQM
2 USP
7 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 198 Xls

Filters

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Filters

FILTER :

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15 All

01 1Cohance Lifesciences

02 1Medichem S.A

03 1Arevipharma

04 1Aurore Life Sciences

05 1Cambrex Corporation

06 1Global Calcium

07 1Mankind Pharma

08 1R L Fine Chem

09 1SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL

10 1Sandoz B2B

11 1Shouguang Fukang Pharmaceutical Co., Ltd

12 1Viatris

13 1Wuhan Shiji Pharmaceutical

14 2Blank

filter Subject Reset all filters

15 All

01 9CLOZAPINE

02 5CLOZAPINE USP

03 1CLOZAPINE, USP

filter Country Reset all filters

15 All

01 3China

02 1Germany

03 5India

04 1Spain

05 1Switzerland

06 2U.S.A

07 2Blank

filter Status Reset all filters

15 All

01 11Active

02 4Inactive

filter GDUFA DMF Review Reset all filters

15 All

01 6Complete

02 9Blank

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

List of Suppliers

Product Main Page

01

Cohance Lifesciences Ltd

CPhI Worldwide, Milan

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Contact Supplier

Contact Supplier

Digital Content

Clozapine Usp

GDUFA

DMF Review : Complete

Rev. Date : 2019-01-29

Pay. Date : 2018-12-07

DMF Number : 31999

Submission : 2017-08-24

Status : Active

Type : II

Product Web Link

Digital Content

02

Medichem Sa

CPhI Worldwide, Milan

Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

Contact Supplier

Contact Supplier

Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2015-01-29

Pay. Date : 2015-01-26

DMF Number : 10534

Submission : 1993-10-21

Status : Active

Type : II

Product Web Link

Digital Content

03

Aurore Life Sciences Private Ltd

USDMF

Formnext Forum

Not Confirmed

03

Aurore Life Sciences Private 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.

Post an Enquiry

Post an Enquiry

Digital Content

Clozapine Usp

GDUFA

DMF Review : Complete

Rev. Date : 2023-01-26

Pay. Date : 2022-12-12

DMF Number : 36645

Submission : 2021-12-23

Status : Active

Type : II

Product Web Link

Digital Content

04

Cambrex Profarmaco Milano Srl

USDMF

Formnext Forum

Not Confirmed

04

Cambrex Profarmaco Milano Srl

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.

Post an Enquiry

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Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2013-10-04

Pay. Date : 2013-09-30

DMF Number : 11692

Submission : 1995-10-03

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Global Calcium Private Ltd

USDMF

Formnext Forum

Not Confirmed

05

Global Calcium Private 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.

Post an Enquiry

Post an Enquiry

Digital Content

Clozapine Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 36869

Submission : 2022-03-23

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

06

Mankind Pharma Ltd

USDMF

Formnext Forum

Not Confirmed

06

Mankind Pharma 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.

Post an Enquiry

Post an Enquiry

Digital Content

Clozapine Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 37540

Submission : 2023-02-01

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Shanghai Zhongxi Sunve Pharmaceutica...

USDMF

Formnext Forum

Not Confirmed

07

Shanghai Zhongxi Sunve Pharmaceutica...

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.

Post an Enquiry

Post an Enquiry

Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 11195

Submission : 1994-11-16

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Shouguang Fukang Pharmaceutical Co L...

USDMF

Formnext Forum

Not Confirmed

08

Shouguang Fukang Pharmaceutical Co L...

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.

Post an Enquiry

Post an Enquiry

Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2014-08-29

Pay. Date : 2013-09-25

DMF Number : 25182

Submission : 2011-08-03

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Tianish Laboratories Private Ltd

USDMF

Formnext Forum

Not Confirmed

09

Tianish Laboratories Private 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.

Post an Enquiry

Post an Enquiry

Digital Content

Clozapine Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-11-04

Pay. Date : 2013-08-27

DMF Number : 27379

Submission : 2013-09-17

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Wuhan Shiji Pharmaceutical Co Ltd

USDMF

Formnext Forum

Not Confirmed

10

Wuhan Shiji Pharmaceutical 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.

Post an Enquiry

Post an Enquiry

Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 19822

Submission : 2006-10-02

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

1
2

MolPort-001-728-041 Manufacturers | Traders | Suppliers

MolPort-001-728-041 Manufacturers, Traders, Suppliers 1

81

We have 13 companies offering MolPort-001-728-041

Get in contact with the supplier of your choice:

Cohance Lifesciences
Medichem S.A
Arevipharma
Aurore Life Sciences
Cambrex Corporation
Global Calcium
Mankind Pharma
R L Fine Chem
Sandoz B2B
SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL
Shouguang Fukang Pharmaceutical Co., Ltd
Viatris
Wuhan Shiji Pharmaceutical

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