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

Client Email

Product

Lactulose
Epilactose
D-(-)-Fructose
A-Lactulose
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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Lactulose

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

31 API Suppliers, 20 USDMF, 13 CEP/COS, 4 JDMF, 2 NDC API, 5 Listed Suppliers, $ API Reference Price

31 API Suppliers
20 USDMF
13 CEP/COS
4 JDMF
2 NDC API
5 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 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

98 FDF Dossiers, 37 FDA Orange Book, 40 Europe, 9 Canada, 12 Listed Dossiers

98 FDF Dossiers
37 FDA Orange Book
40 Europe
9 Canada
12 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 1 Pfanstiehl, 2 BASF, 3 Kerry, 1 Roquette, 1 Shanghai Hegeng Industrial Co. Ltd, 1 Shijiazhuang Huaxu Pharmaceutical

1 SPI Pharma
1 Pfanstiehl
2 BASF
3 Kerry
1 Roquette
1 Shanghai Hegeng Industrial Co. Ltd
1 Shijiazhuang Huaxu Pharmaceutical

EXCIPIENTS BY APPLICATIONS

3 Co-Processed Excipients, 3 Parenteral, 3 Direct Compression, 2 Granulation, 1 Controlled & Modified Release, 1 Thickeners and Stabilizers, 1 Fillers, Diluents & Binders, 1 Taste Masking, 1 Chewable & Orodispersible Aids, 1 Coating Systems & Additives

3 Co-Processed Excipients
3 Parenteral
3 Direct Compression
2 Granulation
1 Controlled & Modified Release
1 Thickeners and Stabilizers
1 Fillers, Diluents & Binders
1 Taste Masking
1 Chewable & Orodispersible Aids
1 Coating Systems & Additives

DIGITAL CONTENT

4 NEWS #PharmaBuzz

4 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

5 US Medicaid Prescriptions, 28 Finished Drug Prices

5 US Medicaid Prescriptions
28 Finished Drug Prices

MARKET PLACE

54 APIs, 8 FDF Dossiers, 5 EXCIPIENTS

54 APIs
8 FDF Dossiers
5 EXCIPIENTS

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 1 JP, 2 Others

3 EDQM
1 USP
1 JP
2 Others

$ API Ref.Price (USD/KG) : 3 Xls

Filters

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Filters

FILTER :

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20 All

01 1Abbott Laboratories

02 2DANIPHARM A S

03 4Fresenius Kabi Austria

04 4Inalco SpA

05 1Lactose India Limited

06 1RELAX LTD

07 3SOLVAY -Technology Solutions

08 1Syngars Technology

09 1Zambon Switzerland

10 2Blank

filter Subject Reset all filters

20 All

01 2LACTULOSE

02 1LACTULOSE 50% SYRUP

03 2LACTULOSE CONCENTRATE

04 1LACTULOSE CONCENTRATE (BULK)

05 4LACTULOSE CONCENTRATE USP

06 1LACTULOSE CRYSTALLINE

07 3LACTULOSE CRYSTALS

08 1LACTULOSE PURUM LIQUIDUM

09 1LACTULOSE SOLUTION

10 2LACTULOSE SOLUTION USP

11 1LACTULOSE SYRUP (MLS-50)

12 1PURIFIED LACTULOSE SYRUP

filter Country Reset all filters

20 All

01 4Austria

02 1China

03 2Denmark

04 3Germany

05 1India

06 4Italy

07 1Malta

08 1Switzerland

09 1U.S.A

10 2Blank

filter Status Reset all filters

20 All

01 9Active

02 11Inactive

filter GDUFA DMF Review Reset all filters

20 All

01 5Complete

02 15Blank

API Suppliers
USDMF
CEP/COS
JDMF
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Abbott Laboratories Co

USDMF

Discovery on Target

Not Confirmed

01

Abbott Laboratories Co

Discovery on Target

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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Post an Enquiry

Digital Content

Lactulose Concentrate Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 10145

Submission : 1993-03-19

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Danipharm As

USDMF

Luxepack

Not Confirmed

02

Danipharm As

Luxepack

Not Confirmed

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Digital Content

Lactulose Concentrate

GDUFA

DMF Review : Complete

Rev. Date : 2017-03-28

Pay. Date : 2016-09-30

DMF Number : 8760

Submission : 1990-09-20

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Fresenius Kabi Austria Gmbh

Austria

USDMF

Luxepack

Not Confirmed

03

Fresenius Kabi Austria Gmbh

Austria

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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Austria

Digital Content

Lactulose Concentrate Usp

GDUFA

DMF Review : Complete

Rev. Date : 2017-02-22

Pay. Date : 2017-01-23

DMF Number : 20562

Submission : 2007-05-29

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Fresenius Kabi Austria Gmbh

Austria

USDMF

Luxepack

Not Confirmed

04

Fresenius Kabi Austria Gmbh

Austria

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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Austria

Digital Content

Lactulose Crystals

GDUFA

DMF Review : Complete

Rev. Date : 2013-06-25

Pay. Date : 2012-11-28

DMF Number : 15254

Submission : 2001-02-16

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Fresenius Kabi Austria Gmbh

Austria

USDMF

Luxepack

Not Confirmed

05

Fresenius Kabi Austria Gmbh

Austria

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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Austria

Digital Content

Lactulose Solution Usp

GDUFA

DMF Review : Complete

Rev. Date : 2015-09-09

Pay. Date : 2014-12-12

DMF Number : 15253

Submission : 2001-02-16

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Inalco Sas Di Giovanni Cipolletti An...

USDMF

Luxepack

Not Confirmed

06

Inalco Sas Di Giovanni Cipolletti An...

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

Lactulose 50% Syrup

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 5412

Submission : 1984-02-07

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Website

Corporate PDF

07

Lactose (india) Limited

USDMF

Luxepack

Not Confirmed

07

Lactose (india) Limited

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

Lactulose Concentrate Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39039

Submission : 2024-01-18

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Relax Ltd

USDMF

Luxepack

Not Confirmed

08

Relax 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.

Post an Enquiry

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Digital Content

Lactulose Concentrate Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-03-15

Pay. Date : 2013-03-04

DMF Number : 8195

Submission : 1989-09-08

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Solvay Duphar Bv

Germany

USDMF

Luxepack

Not Confirmed

09

Solvay Duphar Bv

Germany

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.

Post an Enquiry

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Germany

Digital Content

Lactulose Solution

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 835

Submission : 1964-09-09

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Website

Corporate PDF

10

Syngars Technology Co Ltd

USDMF

Luxepack

Not Confirmed

10

Syngars Technology Co 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.

Post an Enquiry

Post an Enquiry

Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38252

Submission : 2023-03-28

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

1
2

Lactulose Manufacturers | Traders | Suppliers

Lactulose Manufacturers, Traders, Suppliers 1

99

We have 9 companies offering Lactulose

Get in contact with the supplier of your choice:

Abbott Laboratories
DANIPHARM A S
Fresenius Kabi Austria
Inalco SpA
Lactose India Limited
RELAX LTD
SOLVAY -Technology Solutions
Syngars Technology
Zambon Switzerland

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