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

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Product

GALANTAMINE HBR
USDMF

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GALANTAMINE HBR

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

29 API Suppliers, 15 USDMF, 8 CEP/COS, 3 JDMF, 2 EU WC, 5 KDMF, 7 NDC API, 15 Listed Suppliers, $ API Reference Price

29 API Suppliers
15 USDMF
8 CEP/COS
3 JDMF
2 EU WC
5 KDMF
7 NDC API
15 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 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

INTERMEDIATES

1 API Suppliers

1 API Suppliers

FINISHED DOSAGE FORMULATIONS

246 FDF Dossiers, 71 FDA Orange Book, 110 Europe, 15 Canada, 24 Australia, 9 South Africa, 17 Listed Dossiers

246 FDF Dossiers
71 FDA Orange Book
110 Europe
15 Canada
24 Australia
9 South Africa
17 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - EQ 16MG BASE, CAPSULE, EXTENDED RELEASE;ORAL - EQ 24MG BASE, CAPSULE, EXTENDED RELEASE;ORAL - EQ 8MG BASE

TABLET;ORAL - EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - EQ 16MG BASE
CAPSULE, EXTENDED RELEASE;ORAL - EQ 24MG BASE
CAPSULE, EXTENDED RELEASE;ORAL - EQ 8MG BASE

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 9 DKSH, 2 Jai Radhe Sales, 5 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 13 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 30 BASF, 1 Clariant, 11 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 37 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 5 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 19 Roquette, 14 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 2 Vertellus

EXCIPIENTS BY APPLICATIONS

92 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 48 Direct Compression, 35 Disintegrants & Superdisintegrants, 33 Controlled & Modified Release, 33 Thickeners and Stabilizers, 30 Granulation, 26 Solubilizers, 23 Taste Masking, 22 Lubricants & Glidants, 19 Chewable & Orodispersible Aids, 19 Co-Processed Excipients, 18 Film Formers & Plasticizers, 17 Parenteral, 15 Topical, 9 Empty Capsules, 8 Emulsifying Agents, 6 API Stability Enhancers, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Rheology Modifiers

92 Fillers, Diluents & Binders
53 Coating Systems & Additives
48 Direct Compression
35 Disintegrants & Superdisintegrants
33 Controlled & Modified Release
33 Thickeners and Stabilizers
30 Granulation
26 Solubilizers
23 Taste Masking
22 Lubricants & Glidants
19 Chewable & Orodispersible Aids
19 Co-Processed Excipients
18 Film Formers & Plasticizers
17 Parenteral
15 Topical
9 Empty Capsules
8 Emulsifying Agents
6 API Stability Enhancers
5 Surfactant & Foaming Agents
5 Coloring Agents
4 Vegetarian Capsules
4 Rheology Modifiers

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 8 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
8 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 96 Finished Drug Prices, 6 Annual Reports

3 US Medicaid Prescriptions
96 Finished Drug Prices
6 Annual Reports

MARKET PLACE

5 APIs

5 APIs

PATENTS & EXCLUSIVITIES

20 Health Canada Patents

20 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 3 USP, 3 Others

4 EDQM
3 USP
3 Others

$ API Ref.Price (USD/KG) : 5,252 Xls

Filters

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15 All

01 2Ajinomoto Company

02 1Aurobindo Pharma Limited

03 2Johnson & Johnson Innovative Medicine

04 1Jubilant Generics

05 1RANBAXY LABORATORIES LIMITED

06 1Sanochemia Pharmazeutika GmbH

07 2ScinoPharm Taiwan, Ltd

08 1Teva API

09 1Wuhan Shiji Pharmaceutical

10 1ZHEJIANG YIXIN PHARMACEUTICAL CO LTD

11 2Blank

filter Subject Reset all filters

15 All

01 1GALANTAMINE

02 1GALANTAMINE HBR

03 1GALANTAMINE HBR.

04 5GALANTAMINE HYDROBROMIDE

05 1GALANTAMINE HYDROBROMIDE (NON-STERILE DRUG SUBSTANCE)

06 1GALANTAMINE HYDROBROMIDE DRUG SUBSTANCE(SYNTHETIC)

07 2GALANTAMINE HYDROBROMIDE USP

08 1GALANTAMINE HYDROBROMIDE USP (NON-STERILE DRUG SUBSTANCE)

09 1GALANTHAMINE HYDROBROMIDE

10 1Galanthamine Hydrobromide (Non-Sterile Bulk Form)

filter Country Reset all filters

15 All

01 1Austria

02 2China

03 3India

04 1Israel

05 2Japan

06 2Taiwan

07 2U.S.A

08 2Blank

filter Status Reset all filters

15 All

01 7Active

02 8Inactive

filter GDUFA DMF Review Reset all filters

15 All

01 2Complete

02 13Blank

Capital Farma Galantamine Hydrobromide

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

List of Suppliers

Product Main Page

01

Apitoria Pharma Private Ltd

USDMF

Formnext Forum

Not Confirmed

01

Apitoria Pharma Private Ltd

Formnext Forum

Not Confirmed

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Digital Content

Galantamine Hydrobromide Usp (non-sterile Drug...

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 21934

Submission : 2008-09-02

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

02

Janssen Pharmaceutica Nv

USDMF

Formnext Forum

Not Confirmed

02

Janssen Pharmaceutica Nv

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Not Confirmed

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Digital Content

Galantamine Hydrobromide Drug Substance(synthe...

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 15384

Submission : 2001-05-08

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Janssen Pharmaceutica Nv

USDMF

Formnext Forum

Not Confirmed

03

Janssen Pharmaceutica Nv

Formnext Forum

Not Confirmed

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Digital Content

Galantamine Hydrobromide

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 14425

Submission : 1999-09-29

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Jubilant Pharmova Ltd

USDMF

Formnext Forum

Not Confirmed

04

Jubilant Pharmova Ltd

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Digital Content

Galantamine Hydrobromide

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 21989

Submission : 2008-11-26

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Sanochemia Pharmazeutika Ag

USDMF

Formnext Forum

Not Confirmed

05

Sanochemia Pharmazeutika Ag

Formnext Forum

Not Confirmed

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Digital Content

Galantamine Hydrobromide

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 26643

Submission : 2012-11-26

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Scinopharm Taiwan Ltd

USDMF

Formnext Forum

Not Confirmed

06

Scinopharm Taiwan Ltd

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Digital Content

Galantamine

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 27564

Submission : 2013-12-30

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

07

Scinopharm Taiwan Ltd

USDMF

Formnext Forum

Not Confirmed

07

Scinopharm Taiwan Ltd

Formnext Forum

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Digital Content

Galantamine Hydrobromide Usp

GDUFA

DMF Review : Complete

Rev. Date : 2015-08-24

Pay. Date : 2015-08-17

DMF Number : 17863

Submission : 2004-12-01

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

08

Teva Pharmaceutical Industries Ltd

USDMF

Formnext Forum

Not Confirmed

08

Teva Pharmaceutical Industries Ltd

Formnext Forum

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Digital Content

Galanthamine Hydrobromide

GDUFA

DMF Review : Complete

Rev. Date : 2014-12-05

Pay. Date : 2012-11-08

DMF Number : 18112

Submission : 2005-02-23

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

09

Wuhan Shiji Pharmaceutical Co Ltd

USDMF

Formnext Forum

Not Confirmed

09

Wuhan Shiji Pharmaceutical Co Ltd

Formnext Forum

Not Confirmed

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Digital Content

Galantamine Hydrobromide

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17967

Submission : 2005-01-03

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Zhejiang Yixin Pharmaceutical Co Ltd

China

USDMF

Formnext Forum

Not Confirmed

10

Zhejiang Yixin Pharmaceutical Co Ltd

China

Formnext Forum

Not Confirmed

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China

Digital Content

Galantamine Hbr.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17972

Submission : 2005-01-05

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

1
2

GALANTAMINE HBR Manufacturers | Traders | Suppliers

GALANTAMINE HBR Manufacturers, Traders, Suppliers 1

93

We have 10 companies offering GALANTAMINE HBR

Get in contact with the supplier of your choice:

Ajinomoto Company
Aurobindo Pharma Limited
Johnson & Johnson Innovative Medicine
Jubilant Generics
RANBAXY LABORATORIES LIMITED
Sanochemia Pharmazeutika GmbH
ScinoPharm Taiwan, Ltd
Teva API
Wuhan Shiji Pharmaceutical
ZHEJIANG YIXIN PHARMACEUTICAL CO LTD

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