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

Client Email

Product

Guanfacine
Palmitoylethanolamide
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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Guanfacine

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

14 API Suppliers, 10 USDMF, 1 JDMF, 1 EU WC, 9 NDC API, 6 Listed Suppliers, $ API Reference Price

14 API Suppliers
10 USDMF
1 JDMF
1 EU WC
9 NDC API
6 Listed Suppliers
$ API Reference Price

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

111 FDF Dossiers, 73 FDA Orange Book, 18 Europe, 12 Canada, 4 Australia, 4 Listed Dossiers

111 FDF Dossiers
73 FDA Orange Book
18 Europe
12 Canada
4 Australia
4 Listed Dossiers

RELATED EXCIPIENT COMPANIES

2 Evonik, 4 SPI Pharma, 2 Seqens, 1 DKSH, 6 Boai NKY Pharmaceuticals Ltd, 11 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 33 BASF, 15 Corel Pharma Chem, 5 DFE Pharma, 1 Finar, 9 Gangwal Chemicals, 13 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 36 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 17 Roquette, 7 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

72 Fillers, Diluents & Binders, 64 Coating Systems & Additives, 42 Controlled & Modified Release, 39 Direct Compression, 28 Granulation, 23 Disintegrants & Superdisintegrants, 21 Solubilizers, 21 Thickeners and Stabilizers, 18 Lubricants & Glidants, 16 Co-Processed Excipients, 13 Taste Masking, 12 Film Formers & Plasticizers, 11 Topical, 9 Chewable & Orodispersible Aids, 6 Parenteral, 5 Empty Capsules, 5 Emulsifying Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 2 Coloring Agents, 2 Rheology Modifiers, 1 Surfactant & Foaming Agents

72 Fillers, Diluents & Binders
64 Coating Systems & Additives
42 Controlled & Modified Release
39 Direct Compression
28 Granulation
23 Disintegrants & Superdisintegrants
21 Solubilizers
21 Thickeners and Stabilizers
18 Lubricants & Glidants
16 Co-Processed Excipients
13 Taste Masking
12 Film Formers & Plasticizers
11 Topical
9 Chewable & Orodispersible Aids
6 Parenteral
5 Empty Capsules
5 Emulsifying Agents
4 Vegetarian Capsules
4 API Stability Enhancers
2 Coloring Agents
2 Rheology Modifiers
1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 23 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
23 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 16 Finished Drug Prices, 10 Annual Reports

2 US Medicaid Prescriptions
16 Finished Drug Prices
10 Annual Reports

MARKET PLACE

6 APIs, 1 FDF Dossiers

6 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 Health Canada Patents

4 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 USP, 2 Others

1 USP
2 Others

$ API Ref.Price (USD/KG) : 4,952 Xls

Filters

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10 All

01 1Medichem S.A

02 1Jubilant Generics

03 1PharmaBlock Sciences

04 1Procos

05 1Quimica Sintetica

06 2Sandoz B2B

07 1Torrent Pharmaceuticals Limited

08 1Unichem Laboratories Limited

09 1Zhejiang Guobang Pharmaceutical

filter Subject Reset all filters

10 All

01 1GUANFACINE HCL

02 5GUANFACINE HYDROCHLORIDE

03 3GUANFACINE HYDROCHLORIDE USP

04 1GUANFACINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE

filter Country Reset all filters

10 All

01 2China

02 3India

03 1Italy

04 2Spain

05 2Switzerland

filter Status Reset all filters

10 All

01 8Active

02 2Inactive

filter GDUFA DMF Review Reset all filters

10 All

01 6Complete

02 4Blank

API Suppliers
USDMF
JDMF
EU WC
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Medichem Sa

CPhI Worldwide, Milan

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

Contact Supplier

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Digital Content

Guanfacine Hydrochloride

GDUFA

DMF Review : Complete

Rev. Date : 2013-02-26

Pay. Date : 2013-02-05

DMF Number : 8590

Submission : 1990-06-12

Status : Active

Type : II

Product Web Link

Digital Content

02

Jubilant Pharmova Ltd

USDMF

Formnext Forum

Not Confirmed

02

Jubilant Pharmova Ltd

Formnext Forum

Not Confirmed

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Digital Content

Guanfacine Hydrochloride Usp

GDUFA

DMF Review : Complete

Rev. Date : 2016-11-18

Pay. Date : 2016-08-23

DMF Number : 28049

Submission : 2014-03-07

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Pharmablock Pharmaceuticals (zhejian...

USDMF

Formnext Forum

Not Confirmed

03

Pharmablock Pharmaceuticals (zhejian...

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Not Confirmed

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Digital Content

Guanfacine Hydrochloride, Non-sterile, Bulk Dr...

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 36431

Submission : 2021-12-23

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Procos Spa

USDMF

Formnext Forum

Not Confirmed

04

Procos Spa

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Not Confirmed

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Digital Content

Guanfacine Hydrochloride

GDUFA

DMF Review : Complete

Rev. Date : 2015-02-24

Pay. Date : 2014-06-19

DMF Number : 28312

Submission : 2014-05-19

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

05

Quimica Sintetica Sa

USDMF

Formnext Forum

Not Confirmed

05

Quimica Sintetica Sa

Formnext Forum

Not Confirmed

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Digital Content

Guanfacine Hydrochloride

GDUFA

DMF Review : Complete

Rev. Date : 2014-08-01

Pay. Date : 2014-07-29

DMF Number : 8661

Submission : 1990-07-12

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Sandoz Ltd Pharmaceutical Div Chemic...

USDMF

Formnext Forum

Not Confirmed

06

Sandoz Ltd Pharmaceutical Div Chemic...

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Digital Content

Guanfacine Hcl

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 4784

Submission : 1982-12-06

Status : Inactive

Type : II

Product Web Link

Digital Content

07

Sandoz Pharmaceuticals Corp Div Sand...

USDMF

Formnext Forum

Not Confirmed

07

Sandoz Pharmaceuticals Corp Div Sand...

Formnext Forum

Not Confirmed

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Digital Content

Guanfacine Hydrochloride

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 4985

Submission : 1983-04-22

Status : Inactive

Type : II

Product Web Link

Digital Content

08

Torrent Pharmaceuticals Ltd

USDMF

Formnext Forum

Not Confirmed

08

Torrent Pharmaceuticals Ltd

Formnext Forum

Not Confirmed

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Digital Content

Guanfacine Hydrochloride Usp

GDUFA

DMF Review : Complete

Rev. Date : 2014-10-27

Pay. Date : 2014-07-15

DMF Number : 28443

Submission : 2014-08-04

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Unichem Laboratories Ltd

USDMF

Formnext Forum

Not Confirmed

09

Unichem Laboratories Ltd

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Not Confirmed

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Digital Content

Guanfacine Hydrochloride Usp

GDUFA

DMF Review : Complete

Rev. Date : 2020-10-14

Pay. Date : 2020-09-08

DMF Number : 34653

Submission : 2020-03-26

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Zhejiang Guobang Pharmaceutical Co L...

USDMF

Formnext Forum

Not Confirmed

10

Zhejiang Guobang Pharmaceutical Co L...

Formnext Forum

Not Confirmed

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Digital Content

Guanfacine Hydrochloride

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39404

Submission : 2024-01-11

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

Guanfacine Manufacturers | Traders | Suppliers

Guanfacine Manufacturers, Traders, Suppliers 1

59

We have 9 companies offering Guanfacine

Get in contact with the supplier of your choice:

Medichem S.A
Jubilant Generics
PharmaBlock Sciences
Procos
Quimica Sintetica
Sandoz B2B
Torrent Pharmaceuticals Limited
Unichem Laboratories Limited
Zhejiang Guobang Pharmaceutical

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