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

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Product

Lisdexamfetamine
USDMF

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Lisdexamfetamine

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

21 API Suppliers, 10 USDMF, 2 EU WC, 10 NDC API, 13 Listed Suppliers, $ API Reference Price

21 API Suppliers
10 USDMF
2 EU WC
10 NDC API
13 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports

API Reference Price
API Exports
API Imports

INTERMEDIATES

1 API Suppliers

1 API Suppliers

FINISHED DOSAGE FORMULATIONS

239 FDF Dossiers, 133 FDA Orange Book, 58 Europe, 32 Canada, 6 Australia, 3 South Africa, 7 Listed Dossiers

239 FDF Dossiers
133 FDA Orange Book
58 Europe
32 Canada
6 Australia
3 South Africa
7 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 10MG, CAPSULE;ORAL - 20MG, CAPSULE;ORAL - 30MG, CAPSULE;ORAL - 40MG, CAPSULE;ORAL - 50MG, CAPSULE;ORAL - 60MG, CAPSULE;ORAL - 70MG

CAPSULE;ORAL - 10MG
CAPSULE;ORAL - 20MG
CAPSULE;ORAL - 30MG
CAPSULE;ORAL - 40MG
CAPSULE;ORAL - 50MG
CAPSULE;ORAL - 60MG
CAPSULE;ORAL - 70MG

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 13 SPI Pharma, 8 DKSH, 1 Jai Radhe Sales, 1 Pharm-RX Chemical, 8 Gangwal Healthcare, 1 Pfanstiehl, 4 ACG Worldwide, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 BASF, 1 Bioplus Life Sciences, 3 DFE Pharma, 5 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 5 Kerry, 3 Lonza Capsugel, 9 Microlex e.U, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qualicaps, 13 Roquette, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 3 Vasa Pharmachem

2 Rochem International Inc
13 SPI Pharma
8 DKSH
1 Jai Radhe Sales
1 Pharm-RX Chemical
8 Gangwal Healthcare
1 Pfanstiehl
4 ACG Worldwide
5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
1 BASF
1 Bioplus Life Sciences
3 DFE Pharma
5 Gangwal Chemicals
1 Ideal Cures Pvt Ltd
2 Ingredion Pharma Solutions
5 Kerry
3 Lonza Capsugel
9 Microlex e.U
1 Pharmatrans-Sanaq
4 Pluviaendo
3 Prachin Chemical
1 Qualicaps
13 Roquette
4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
9 Sigachi Industries
3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

42 Fillers, Diluents & Binders, 22 Direct Compression, 16 Thickeners and Stabilizers, 14 Disintegrants & Superdisintegrants, 13 Taste Masking, 11 Lubricants & Glidants, 11 Co-Processed Excipients, 11 Chewable & Orodispersible Aids, 10 Granulation, 8 Empty Capsules, 7 Coating Systems & Additives, 4 Controlled & Modified Release, 4 Parenteral, 3 Film Formers & Plasticizers, 3 Coloring Agents, 3 Emulsifying Agents, 2 API Stability Enhancers, 2 Rheology Modifiers

42 Fillers, Diluents & Binders
22 Direct Compression
16 Thickeners and Stabilizers
14 Disintegrants & Superdisintegrants
13 Taste Masking
11 Lubricants & Glidants
11 Co-Processed Excipients
11 Chewable & Orodispersible Aids
10 Granulation
8 Empty Capsules
7 Coating Systems & Additives
4 Controlled & Modified Release
4 Parenteral
3 Film Formers & Plasticizers
3 Coloring Agents
3 Emulsifying Agents
2 API Stability Enhancers
2 Rheology Modifiers

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 39 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
39 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 55 Finished Drug Prices, 1 Annual Reports

1 US Medicaid Prescriptions
55 Finished Drug Prices
1 Annual Reports

MARKET PLACE

8 APIs, 3 FDF Dossiers

8 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

7 Health Canada Patents

7 Health Canada Patents

$ API Ref.Price (USD/KG) : 3,811 Xls

Filters

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10 All

01 2Veranova

02 1Noramco

03 2Alkem Laboratories

04 1Cambrex Corporation

05 1Chattem Chemicals, Inc

06 1DMFs Not Supported

07 2Mallinckrodt Pharmaceuticals

filter Subject Reset all filters

10 All

01 1Bis-Boc-Lisdexamfetamine

02 5LISDEXAMFETAMINE DIMESYLATE

03 1LISDEXAMFETAMINE DIMESYLATE B1625

04 1LISDEXAMFETAMINE DIMESYLATE DRUG SUBSTANCE

05 1LISDEXAMFETAMINE DIMESYLATE INT

06 1MMB4 DIMESYLATE

filter Country Reset all filters

10 All

01 2India

02 2Ireland

03 5U.S.A

04 1Blank

filter Status Reset all filters

10 All

01 8Active

02 2Inactive

filter GDUFA DMF Review Reset all filters

10 All

01 5Complete

02 5Blank

Lisdexamfetamine Dimesylate

API Suppliers
USDMF
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

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Digital Content

Lisdexamfetamine Dimesylate

GDUFA

DMF Review : Complete

Rev. Date : 2020-01-28

Pay. Date : 2020-01-21

DMF Number : 22442

Submission : 2009-01-27

Status : Active

Type : II

Product Web Link

Digital Content

02

Noramco Llc

CPhI Worldwide, Milan

Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.

Contact Supplier

Contact Supplier

Digital Content

Lisdexamfetamine Dimesylate Drug Substance

GDUFA

DMF Review : Complete

Rev. Date : 2021-12-30

Pay. Date : 2021-11-18

DMF Number : 35645

Submission : 2021-11-23

Status : Active

Type : II

Product Web Link

Digital Content

03

Veranova Lp

CPhI Worldwide, Milan

Veranova: A CDMO that manages complexity with confidence.

Contact Supplier

Contact Supplier

Digital Content

Lisdexamfetamine Dimesylate B1625

GDUFA

DMF Review : Complete

Rev. Date : 2023-11-21

Pay. Date : 2023-10-12

DMF Number : 38874

Submission : 2023-10-20

Status : Active

Type : II

Product Web Link

Digital Content

04

Alkem Laboratories Ltd

USDMF

Pharmaconex 2024

Not Confirmed

04

Alkem Laboratories Ltd

Pharmaconex 2024

Not Confirmed

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Digital Content

Lisdexamfetamine Dimesylate

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38667

Submission : 2023-08-03

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

05

Alkem Laboratories Ltd

USDMF

Pharmaconex 2024

Not Confirmed

05

Alkem Laboratories Ltd

Pharmaconex 2024

Not Confirmed

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Digital Content

Bis-boc-lisdexamfetamine

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 36325

Submission : 2021-10-25

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

06

Cambrex Charles City Inc

USDMF

Pharmaconex 2024

Not Confirmed

06

Cambrex Charles City Inc

Pharmaconex 2024

Not Confirmed

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Digital Content

Mmb4 Dimesylate

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 20103

Submission : 2006-12-29

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Chattem Chemicals Inc

USDMF

Pharmaconex 2024

Not Confirmed

07

Chattem Chemicals Inc

Pharmaconex 2024

Not Confirmed

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Digital Content

Lisdexamfetamine Dimesylate

GDUFA

DMF Review : Complete

Rev. Date : 2019-07-02

Pay. Date : 2018-05-22

DMF Number : 32289

Submission : 2018-05-18

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Website

Corporate PDF

08

August Pharmaceuticals Llc

Country

USDMF

Pharmaconex 2024

Not Confirmed

08

August Pharmaceuticals Llc

Country

Pharmaconex 2024

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

Lisdexamfetamine Dimesylate Int

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 35754

Submission : 2021-05-28

Status : Active

Type : II

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

09

Specgx Llc

USDMF

Pharmaconex 2024

Not Confirmed

09

Specgx Llc

Pharmaconex 2024

Not Confirmed

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Post an Enquiry

Digital Content

Lisdexamfetamine Dimesylate

GDUFA

DMF Review : Complete

Rev. Date : 2020-07-28

Pay. Date : 2020-06-03

DMF Number : 34823

Submission : 2020-05-29

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Specgx Llc

USDMF

Pharmaconex 2024

Not Confirmed

10

Specgx Llc

Pharmaconex 2024

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

Lisdexamfetamine Dimesylate

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 32210

Submission : 2017-11-22

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

Lisdexamfetamine Manufacturers | Traders | Suppliers

Lisdexamfetamine Manufacturers, Traders, Suppliers 1

29

We have 6 companies offering Lisdexamfetamine

Get in contact with the supplier of your choice:

Veranova
Noramco
Alkem Laboratories
Cambrex Corporation
Chattem Chemicals, Inc
Mallinckrodt Pharmaceuticals

Contact us
to update this info

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