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Ibandronate Sodium

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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

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

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TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INTRAVENOUS - EQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Rochem International Inc, 4 SPI Pharma, 2 Seqens, 4 DKSH, 2 Jai Radhe Sales, 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

60 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 Co-Processed Excipients, 13 Solubilizers, 12 Parenteral, 8 Taste Masking, 7 Chewable & Orodispersible Aids, 5 Empty Capsules, 5 API Stability Enhancers, 5 Coloring Agents, 5 Emulsifying Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules, 1 Soft Gelatin, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

6 NEWS #PharmaBuzz

6 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

112 Finished Drug Prices

112 Finished Drug Prices

MARKET PLACE

6 APIs, 3 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 Health Canada Patents

2 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP, 2 Others

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/10/2024	Polpharma	Poland	ZAKLADY FARMACEUTYCZNE POLPHARMA SA	25638	IBANDRONATE SODIUM MONOHYDRATE	2011-12-29	Active	II	Complete	2016-12-12	2016-06-21
28/10/2024	Apotex Pharmachem	Canada	APOTEX PHARMACHEM INC	20525	IBANDRONATE SODIUM	2007-05-11	Active	II	N/A

Ibandronate Sodium

Ibandronate Sodium

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CHEMISTRY

Discover Molecule Insights

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

DEVELOPMENTS

1 Drugs in Development

INTERMEDIATES

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

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**

RELATED EXCIPIENT COMPANIES

1 Minakem

1 Rochem International Inc

4 SPI Pharma

2 Seqens

4 DKSH

2 Jai Radhe Sales

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

60 Fillers, Diluents & Binders

55 Coating Systems & Additives

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