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Ibandronate Sodium

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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ACTIVE PHARMA INGREDIENTS

35 API Suppliers, 14 USDMF, 3 CEP/COS, 1 JDMF, 7 EU WC, 24 KDMF, 5 NDC API, 20 Listed Suppliers, $ API Reference Price

35 API Suppliers
14 USDMF
3 CEP/COS
1 JDMF
7 EU WC
24 KDMF
5 NDC API
20 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

201 FDF Dossiers, 21 FDA Orange Book, 134 Europe, 1 Australia, 10 South Africa, 35 Listed Dossiers

201 FDF Dossiers
21 FDA Orange Book
134 Europe
1 Australia
10 South Africa
35 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INTRAVENOUS - EQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INTRAVENOUS - EQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Rochem International Inc, 4 SPI Pharma, 2 Seqens, 4 DKSH, 4 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 12 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 22 BASF, 1 Clariant, 10 Corel Pharma Chem, 5 DFE Pharma, 2 Finar, 8 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 4 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 19 Roquette, 7 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

relatedExcipients
1 Minakem
1 Rochem International Inc
4 SPI Pharma
2 Seqens
4 DKSH
4 Faran Shimi Pharmaceutical
1 Boai NKY Pharmaceuticals Ltd
1 Chynops Pharma
12 Gangwal Healthcare
5 Nanjing Well Pharmaceutical
1 ACG Worldwide
5 Actylis
1 Aeon Procare
1 Alcedo Pharmachem
7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
22 BASF
1 Clariant
10 Corel Pharma Chem
5 DFE Pharma
2 Finar
8 Gangwal Chemicals
7 Ideal Cures Pvt Ltd
1 Ingredion Pharma Solutions
31 Kerry
3 Kima Chemical
6 Lonza Capsugel
13 Microlex e.U
1 NEWEDGE Overseas
2 Nomisma Healthcare
3 Novo Excipients
3 Pharmatrans-Sanaq
4 Pluviaendo
4 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
1 Qualicaps
19 Roquette
7 Seppic
4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
11 Sigachi Industries
2 The Dow Chemical Company
1 Valens Pharmachem
3 Vasa Pharmachem
1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

58 Fillers, Diluents & Binders, 55 Coating Systems & Additives, 31 Controlled & Modified Release, 27 Direct Compression, 23 Lubricants & Glidants, 21 Thickeners and Stabilizers, 20 Film Formers & Plasticizers, 20 Disintegrants & Superdisintegrants, 19 Granulation, 14 Topical, 13 Solubilizers, 13 Co-Processed Excipients, 12 Parenteral, 8 Taste Masking, 7 Chewable & Orodispersible Aids, 5 Coloring Agents, 5 Emulsifying Agents, 5 Empty Capsules, 5 API Stability Enhancers, 4 Rheology Modifiers, 4 Vegetarian Capsules, 1 Soft Gelatin, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

6 NEWS #PharmaBuzz

media
6 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

112 Finished Drug Prices

globalSalesInformation
112 Finished Drug Prices

MARKET PLACE

6 APIs, 3 FDF Dossiers

marketPlace
6 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 Health Canada Patents

patents
2 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP , 2 Others

otherSolutions
2 USP
2 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 915

MARKET PLACE

API

FDF

2INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

201

FDF Dossiers

FDA Orange Book

134

Europe

Canada

Australia

South Africa

Listed Dossiers

1DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

Annual Reports (USD Million)

Finished Drug Prices

227 RELATED EXCIPIENT COMPANIES

371EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 138844-81-2, Bondronat, Ibandronate sodium salt, Boniva, Ibandronate (sodium), Sodium ibandronate

Molecular Formula

C₉H₂₂NNaO₇P₂

Molecular Weight

341.21 g/mol

InChI Key

LXLBEOAZMZAZND-UHFFFAOYSA-M

FDA UNII

23Y0B94E49

Aminobisphosphonate that is a potent inhibitor of BONE RESORPTION. It is used in the treatment of HYPERCALCEMIA associated with malignancy, for the prevention of fracture and bone complications in patients with breast cancer and bone metastases, and for the treatment and prevention of POSTMENOPAUSAL OSTEOPOROSIS.

1 2D Structure

Ibandronate Sodium

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

sodium;hydroxy-[1-hydroxy-3-[methyl(pentyl)amino]-1-phosphonopropyl]phosphinate

2.1.2 InChI

InChI=1S/C9H23NO7P2.Na/c1-3-4-5-7-10(2)8-6-9(11,18(12,13)14)19(15,16)17;/h11H,3-8H2,1-2H3,(H2,12,13,14)(H2,15,16,17);/q;+1/p-1

2.1.3 InChI Key

LXLBEOAZMZAZND-UHFFFAOYSA-M

2.1.4 Canonical SMILES

CCCCCN(C)CCC(O)(P(=O)(O)O)P(=O)(O)[O-].[Na+]

2.2 Other Identifiers

2.2.1 UNII

23Y0B94E49

2.3 Synonyms

2.3.1 MeSH Synonyms

1. (1-hydroxy-3-(methylpentylamino)propylidene)bisphosphonate

2. 1-hydroxy-3-(methylpentylamino)propylidenebisphosphonate

3. Bm 21.0955

4. Bm 210955

5. Bm-21.0955

6. Bm-210955

7. Bm21.0955

8. Bm210955

9. Bondronat

10. Boniva

11. Bonviva

12. Ibandronate

13. Ibandronate Sodium Anhydrous

14. Ibandronic Acid

15. Ibandronic Acid, Sodium Salt, Monohydrate

16. Rpr 102289a

17. Rpr-102289a

18. Rpr102289a

2.3.2 Depositor-Supplied Synonyms

1. 138844-81-2

2. Bondronat

3. Ibandronate Sodium Salt

4. Boniva

5. Ibandronate (sodium)

6. Sodium Ibandronate

7. Ibandronate Sodium Anhydrous

8. Bonviva

9. 23y0b94e49

10. (1-hydroxy-3-(methylpentylamino)propylidene)bisphosphonic Acid Sodium

11. Sodium;hydroxy-[1-hydroxy-3-[methyl(pentyl)amino]-1-phosphonopropyl]phosphinate

12. Phosphonic Acid, (1-hydroxy-3-(methylpentylamino)propylidene)bis-, Monosodium Salt

13. Bm 21.0955na

14. Ncgc00167428-01

15. Bm-21.0955

16. Unii-23y0b94e49

17. Dsstox_cid_26618

18. Dsstox_rid_81770

19. Dsstox_gsid_46618

20. Schembl1030768

21. Chembl1201008

22. Dtxsid8046618

23. Hy-b0515b

24. Hms3263m08

25. Hms3714g19

26. Sodium Ibandronate Anhydrous

27. Bcp22744

28. Ibandronate Sodium [who-dd]

29. Tox21_112432

30. Tox21_501103

31. Mfcd07197214

32. Akos026750153

33. Bcp9000767

34. Ccg-220679

35. Ccg-222407

36. Lp01103

37. Ibandronic Acid Sodium Salt [mi]

38. Ncgc00261788-01

39. Cas-138844-81-2

40. Ft-0670252

41. S0877

42. H11437

43. Ibandronate Sodium Salt, >=97% (nmr), Solid

44. J-007183

45. Q27253790

46. (1-hydroxy-3-(methyl(pentyl)amino)propane-1,1-diyl)diphosphonic Acid Monosodium Salt

2.4 Create Date

2008-02-05

3 Chemical and Physical Properties

Molecular Formula	C₉H₂₂NNaO₇P₂
Molecular Weight	341.21 g/mol
Hydrogen Bond Donor Count	4
Hydrogen Bond Acceptor Count	8
Rotatable Bond Count	9
Exact Mass	341.07692032 g/mol
Monoisotopic Mass	341.07692032 g/mol
Topological Polar Surface Area	141 Å²
Heavy Atom Count	20
Formal Charge	0
Complexity	377
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Boniva
PubMed Health	Ibandronate
Drug Classes	Calcium Regulator
Drug Label	BONIVA (ibandronate sodium) is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The chemical name for ibandronate sodium is 3-(N-methyl-N-pentyl)amino-1-hydroxypropane-1,1-diphosphonic acid, monosodium salt, mon...
Active Ingredient	Ibandronate sodium
Dosage Form	Injectable; Tablet
Route	Intravenous; Oral
Strength	eq 3mg base/3ml; eq 150mg base
Market Status	Prescription
Company	Hoffmann La Roche; Roche

2 of 4
Drug Name	Ibandronate sodium
Drug Label	BONIVA (ibandronate sodium) is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The chemical name for ibandronate sodium is 3-(N-methyl-N-pentyl)amino-1-hydroxypropane-1,1-diphosphonic acid, monosodium salt, mon...
Active Ingredient	Ibandronate sodium
Dosage Form	Tablet; Injectable
Route	injection; oral; Oral; Intravenous
Strength	2.5mg; 1mg; eq 150mg base; eq 3mg base/3ml
Market Status	Tentative Approval; Prescription
Company	Mylan Pharms; Teva Parenteral; Apotex; Sun Pharm Inds; Watson Labs; Emcure Pharms; Mutual Pharm; Cobalt Labs; Sagent Pharms; Dr Reddys Labs; Agila Speclts; Orchid Hlthcare

3 of 4
Drug Name	Boniva
PubMed Health	Ibandronate
Drug Classes	Calcium Regulator
Drug Label	BONIVA (ibandronate sodium) is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The chemical name for ibandronate sodium is 3-(N-methyl-N-pentyl)amino-1-hydroxypropane-1,1-diphosphonic acid, monosodium salt, mon...
Active Ingredient	Ibandronate sodium
Dosage Form	Injectable; Tablet
Route	Intravenous; Oral
Strength	eq 3mg base/3ml; eq 150mg base
Market Status	Prescription
Company	Hoffmann La Roche; Roche

4 of 4
Drug Name	Ibandronate sodium
Drug Label	BONIVA (ibandronate sodium) is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The chemical name for ibandronate sodium is 3-(N-methyl-N-pentyl)amino-1-hydroxypropane-1,1-diphosphonic acid, monosodium salt, mon...
Active Ingredient	Ibandronate sodium
Dosage Form	Tablet; Injectable
Route	injection; oral; Oral; Intravenous
Strength	2.5mg; 1mg; eq 150mg base; eq 3mg base/3ml
Market Status	Tentative Approval; Prescription
Company	Mylan Pharms; Teva Parenteral; Apotex; Sun Pharm Inds; Watson Labs; Emcure Pharms; Mutual Pharm; Cobalt Labs; Sagent Pharms; Dr Reddys Labs; Agila Speclts; Orchid Hlthcare

4.2 Drug Indication

Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5. 1). A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.

Bondronat is indicated for:

- prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases;

- treatment of tumour-induced hypercalcaemia with or without metastases.

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Bone Density Conservation Agents

Agents that inhibit BONE RESORPTION and/or favor BONE MINERALIZATION and BONE REGENERATION. They are used to heal BONE FRACTURES and to treat METABOLIC BONE DISEASES such as OSTEOPOROSIS. (See all compounds classified as Bone Density Conservation Agents.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Diphosphonates [CS]; Bisphosphonate [EPC]

5.3 ATC Code

M05BA06

API SUPPLIERS

01

Polpharma

Poland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Pharma, Lab & Chemical Expo

Not Confirmed

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

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Poland

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USDMF

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CEP/COS

JDMF

EU-WC NDC KDMF

VMF ASMF, CN

AUDIT

02

LGM Pharma

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Pharma, Lab & Chemical Expo

Not Confirmed

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

03

Dr. Reddy's Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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04

Jai Radhe Sales

India

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Jai Radhe Sales is your partner for all your sourcing needs.

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05

Laboratorium Ofichem B.V

Netherlands

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.

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06

HRV Global Life Sciences

India

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HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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TAPI Technology & API Services

Israel

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI WW Frankfurt

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TAPI offers customized CDMO Solutions for API development and manufacturing services.

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08

Polpharma

Poland

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Sun Pharmaceutical Industries Limi...

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Roche Diagnostics GmbH

Germany

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API Reference Price

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Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

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Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21455

DOSAGE - TABLET;ORAL - EQ 2.5MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21455

DOSAGE - INJECTABLE;INTRAVENOUS - EQ 3MG BASE...DOSAGE - INJECTABLE;INTRAVENOUS - EQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21858

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DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INTRAVENOUS - EQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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TABLET;ORAL - EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INTRAVENOUS - EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons