Alendronate Sodium | API DMFs | US Drug Master File (DMF) Details | Pharmacompass.com

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Alendronate Sodium
USDMF

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Alendronate Sodium

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

50 API Suppliers, 24 USDMF, 13 CEP/COS, 6 JDMF, 11 EU WC, 13 KDMF, 11 NDC API, 20 Listed Suppliers, $ API Reference Price

50 API Suppliers
24 USDMF
13 CEP/COS
6 JDMF
11 EU WC
13 KDMF
11 NDC API
20 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

FINISHED DOSAGE FORMULATIONS

232 FDF Dossiers, 64 FDA Orange Book, 107 Europe, 25 Canada, 6 Australia, 3 South Africa, 27 Listed Dossiers

232 FDF Dossiers
64 FDA Orange Book
107 Europe
25 Canada
6 Australia
3 South Africa
27 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 70MG BASE, TABLET;ORAL - EQ 70MG BASE;2,800 IU, TABLET;ORAL - EQ 70MG BASE;5,600 IU

TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 70MG BASE
TABLET;ORAL - EQ 70MG BASE;2,800 IU
TABLET;ORAL - EQ 70MG BASE;5,600 IU

RELATED EXCIPIENT COMPANIES

4 Rochem International Inc, 17 SPI Pharma, 6 DKSH, 1 Jai Radhe Sales, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 3 Boai NKY Pharmaceuticals Ltd, 14 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 2 Actylis, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 7 BASF, 1 Bioplus Life Sciences, 7 DFE Pharma, 5 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 26 Kerry, 3 Lonza Capsugel, 12 Microlex e.U, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qualicaps, 18 Roquette, 1 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 1 Ulanqab Kema New Material, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

80 Fillers, Diluents & Binders, 36 Direct Compression, 27 Disintegrants & Superdisintegrants, 23 Taste Masking, 20 Thickeners and Stabilizers, 20 Co-Processed Excipients, 19 Granulation, 15 Lubricants & Glidants, 14 Chewable & Orodispersible Aids, 8 Empty Capsules, 7 Coating Systems & Additives, 6 Controlled & Modified Release, 6 Parenteral, 4 API Stability Enhancers, 3 Emulsifying Agents, 2 Solubilizers, 2 Topical, 2 Rheology Modifiers, 1 Surfactant & Foaming Agents, 1 Film Formers & Plasticizers

80 Fillers, Diluents & Binders
36 Direct Compression
27 Disintegrants & Superdisintegrants
23 Taste Masking
20 Thickeners and Stabilizers
20 Co-Processed Excipients
19 Granulation
15 Lubricants & Glidants
14 Chewable & Orodispersible Aids
8 Empty Capsules
7 Coating Systems & Additives
6 Controlled & Modified Release
6 Parenteral
4 API Stability Enhancers
3 Emulsifying Agents
2 Solubilizers
2 Topical
2 Rheology Modifiers
1 Surfactant & Foaming Agents
1 Film Formers & Plasticizers

DIGITAL CONTENT

5 DATA COMPILATION #PharmaFlow, 25 NEWS #PharmaBuzz

5 DATA COMPILATION #PharmaFlow
25 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 120 Finished Drug Prices, 5 Annual Reports

4 US Medicaid Prescriptions
120 Finished Drug Prices
5 Annual Reports

MARKET PLACE

10 APIs, 1 FDF Dossiers

10 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

1 US Patents, 17 Health Canada Patents

1 US Patents
17 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 4 JP, 1 Others

2 EDQM
1 USP
4 JP
1 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 182 Xls

Filters

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24 All

01 1Polpharma

02 1Alembic Pharmaceuticals Limited

03 1Apotex Inc

04 1Aurobindo Pharma Limited

05 1CSPC Pharmaceutical Group

06 1CTX Lifesciences

07 1Cadila Pharmaceuticals

08 2Chemi SpA

09 1Chongqing Carelife Pharmaceutical

10 1Cipla

11 1Gador SA

12 1Ipca Laboratories

13 1Jubilant Generics

14 1Lupin Ltd

15 1Minsheng Group Shaoxing Pharmaceutical

16 1Orchid Pharma

17 1Signa S.A. de C.V.

18 1Sun Pharmaceutical Industries Limited

19 2Teva API

20 1Trifarma

21 1Viatris

22 1Blank

filter Subject Reset all filters

24 All

01 1ALEDRONATE SODIUM USP

02 1ALENDRONATE MONOSODIUM TRIHYDRATE

03 2ALENDRONATE SODIUM

04 1ALENDRONATE SODIUM NON-STERILE BULK DRUG SUBSTANCE

05 1ALENDRONATE SODIUM TRIHYDRATE

06 2ALENDRONATE SODIUM TRIHYDRATE USP

07 7ALENDRONATE SODIUM USP

08 1ALENDRONATE SODIUM USP (NON-STERILE DRUG SUBSTANCE)

09 1ALENDRONATE SODIUM USP (TRIHYDRATE)

10 1ALENDRONATE SODIUM USP 28

11 4SODIUM ALENDRONATE

12 2SODIUM ALENDRONATE TRIHYDRATE

filter Country Reset all filters

24 All

01 1Argentina

02 1Canada

03 3China

04 10India

05 2Israel

06 3Italy

07 1Mexico

08 1Poland

09 1U.S.A

10 1Blank

filter Status Reset all filters

24 All

01 12Active

02 12Inactive

filter GDUFA DMF Review Reset all filters

24 All

01 4Complete

02 20Blank

Alendronate Sodium

List of Suppliers

Product Main Page

01

Zaklady Farmaceutyczne Polpharma Sa

American Pharma Summit

Not Confirmed

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

Contact Supplier

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Digital Content

Sodium Alendronate

GDUFA

DMF Review : Complete

Rev. Date : 2014-12-16

Pay. Date : 2014-11-28

DMF Number : 16962

Submission : 2003-11-17

Status : Active

Type : II

Product Web Link

Digital Content

02

Apotex Pharmachem Inc

USDMF

American Pharma Summit

Not Confirmed

02

Apotex Pharmachem Inc

American Pharma Summit

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

Alendronate Sodium Trihydrate Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 15409

Submission : 2001-04-30

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Apitoria Pharma Private Ltd

USDMF

American Pharma Summit

Not Confirmed

03

Apitoria Pharma Private Ltd

American Pharma Summit

Not Confirmed

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Digital Content

Alendronate Sodium Usp (non-sterile Drug Subst...

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 20031

Submission : 2006-12-04

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

04

Cadila Pharmaceuticals Ltd

USDMF

American Pharma Summit

Not Confirmed

04

Cadila Pharmaceuticals Ltd

American Pharma Summit

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

Aledronate Sodium Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 20704

Submission : 2007-07-11

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Cipla Ltd

USDMF

American Pharma Summit

Not Confirmed

05

Cipla Ltd

American Pharma Summit

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

Alendronate Sodium Usp

GDUFA

DMF Review : Complete

Rev. Date : 2019-12-15

Pay. Date : 2019-12-11

DMF Number : 14334

Submission : 1999-08-06

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Ipca Laboratories Ltd

USDMF

American Pharma Summit

Not Confirmed

06

Ipca Laboratories Ltd

American Pharma Summit

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

Alendronate Sodium Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-11-14

Pay. Date : 2013-07-30

DMF Number : 21008

Submission : 2007-12-03

Status : Active

Type : II

Product Web Link

Digital Content

07

Orchid Pharma Ltd

USDMF

American Pharma Summit

Not Confirmed

07

Orchid Pharma Ltd

American Pharma Summit

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

Alendronate Sodium Trihydrate

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 20415

Submission : 2007-04-06

Status : Active

Type : II

Product Web Link

Digital Content

08

Sun Pharmaceutical Industries Ltd

USDMF

American Pharma Summit

Not Confirmed

08

Sun Pharmaceutical Industries Ltd

American Pharma Summit

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

Alendronate Sodium Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 20786

Submission : 2007-08-14

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Teva Pharmaceutical Industries Ltd

USDMF

American Pharma Summit

Not Confirmed

09

Teva Pharmaceutical Industries Ltd

American Pharma Summit

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

Alendronate Monosodium Trihydrate

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 18327

Submission : 2005-05-03

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

10

Tianish Laboratories Private Ltd

USDMF

American Pharma Summit

Not Confirmed

10

Tianish Laboratories Private Ltd

American Pharma Summit

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

Alendronate Sodium Usp (trihydrate)

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 20402

Submission : 2007-04-02

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

1
2
3

Alendronate Sodium Manufacturers | Traders | Suppliers

Alendronate Sodium Manufacturers, Traders, Suppliers 1

88

We have 21 companies offering Alendronate Sodium

Get in contact with the supplier of your choice:

Polpharma
Alembic Pharmaceuticals Limited
Apotex Inc
Aurobindo Pharma Limited
Cadila Pharmaceuticals
Chemi SpA
Chongqing Carelife Pharmaceutical
Cipla
CSPC Pharmaceutical Group
CTX Lifesciences
Gador SA
Ipca Laboratories
Jubilant Generics
Lupin Ltd
Minsheng Group Shaoxing Pharmaceutical
Orchid Pharma
Signa S.A. de C.V.
Sun Pharmaceutical Industries Limited
Teva API
Trifarma
Viatris

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