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Approved Drug Products containing Ibandronate Sodium listed in the FDA Orange Book. Original Data : FDA Website

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Product

Ibandronate Sodium
FDA Orange Book

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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Ibandronate Sodium

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

35 API Suppliers, 14 USDMF, 2 CEP/COS, 1 JDMF, 8 EU WC, 23 KDMF, 5 NDC API, 20 Listed Suppliers, $ API Reference Price

35 API Suppliers
14 USDMF
2 CEP/COS
1 JDMF
8 EU WC
23 KDMF
5 NDC API
20 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Imports

INTERMEDIATES

2 API Suppliers

2 API Suppliers

FINISHED DOSAGE FORMULATIONS

200 FDF Dossiers, 21 FDA Orange Book, 134 Europe, 1 Australia, 10 South Africa, 34 Listed Dossiers

200 FDF Dossiers
21 FDA Orange Book
134 Europe
1 Australia
10 South Africa
34 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TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INTRAVENOUS - EQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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, 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, 8 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 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

61 Fillers, Diluents & Binders, 55 Coating Systems & Additives, 31 Controlled & Modified Release, 28 Direct Compression, 23 Lubricants & Glidants, 21 Thickeners and Stabilizers, 21 Disintegrants & Superdisintegrants, 20 Film Formers & Plasticizers, 19 Granulation, 14 Topical, 14 Solubilizers, 13 Co-Processed Excipients, 12 Parenteral, 8 Taste Masking, 7 Chewable & Orodispersible Aids, 5 Emulsifying Agents, 5 Empty Capsules, 5 API Stability Enhancers, 5 Coloring Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules, 1 Soft Gelatin, 1 Surfactant & Foaming Agents

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

6 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 Health Canada Patents

2 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP, 2 Others

2 USP
2 Others

$ API Ref.Price (USD/KG) : 915 Xls

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21 All

01 1ACCORD HLTHCARE

02 1APOTEX

03 1APOTEX INC

04 1AUROBINDO PHARMA

05 1AVET LIFESCIENCES

06 1COBALT LABS INC

07 1DR REDDYS LABS LTD

08 1EUGIA PHARMA

09 2HOFFMANN LA ROCHE

10 1MACLEODS PHARMS LTD

11 1MYLAN LABS LTD

12 1NANG KUANG PHARM CO

13 1NORVIUM BIOSCIENCE

14 1ORBION PHARMS

15 1ROCHE

16 1SAGENT PHARMS INC

17 1SUN PHARM

18 1SUN PHARM INDUSTRIES

19 1TEVA PARENTERAL

20 1WATSON LABS TEVA

filter Dosage Reset all filters

21 All

01 1INJECTABLE; INJECTION

02 9INJECTABLE;INTRAVENOUS

03 1TABLET; ORAL

04 10TABLET;ORAL

filter Regulatory Info Reset all filters

21 All

01 9DISCN

02 10RX

03 2Blank

filter Brand Name Reset all filters

21 All

01 3BONIVA

02 18IBANDRONATE SODIUM

filter RLD Reset all filters

21 All

01 16No

02 3Yes

03 2Blank

FDF Dossiers
FDA Orange Book
Europe
Australia
South Africa
Listed Dossiers

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Product Main Page

01

WATSON LABS TEVA

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Digital Content

RLD : No

TE Code :

IBANDRONATE SODIUM

Brand Name : IBANDRONATE SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date : 2012-03-20

Application Number : 79003

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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02

APOTEX INC

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RLD : No

TE Code : AB

IBANDRONATE SODIUM

Brand Name : IBANDRONATE SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date : 2012-03-19

Application Number : 78948

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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03

COBALT LABS INC

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RLD :

TE Code :

IBANDRONATE SODIUM

Brand Name : IBANDRONATE SODIUM

Dosage Form : TABLET; ORAL

Dosage Strength : 2.5MG

Approval Date :

Application Number : 79002

RX/OTC/DISCN :

RLD :

TE Code :

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04

HOFFMANN LA ROCHE

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RLD : Yes

TE Code :

IBANDRONATE SODIUM

Brand Name : BONIVA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2003-05-16

Application Number : 21455

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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05

HOFFMANN LA ROCHE

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Digital Content

RLD : Yes

TE Code :

IBANDRONATE SODIUM

Brand Name : BONIVA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2005-03-24

Application Number : 21455

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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06

ROCHE

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ROCHE

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Digital Content

RLD : Yes

TE Code :

IBANDRONATE SODIUM

Brand Name : BONIVA

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : EQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2006-01-06

Application Number : 21858

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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07

ORBION PHARMS

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RLD : No

TE Code : AB

IBANDRONATE SODIUM

Brand Name : IBANDRONATE SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date : 2012-03-19

Application Number : 78998

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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08

SUN PHARM INDUSTRIES

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SUN PHARM INDUSTRIES

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Digital Content

RLD : No

TE Code :

IBANDRONATE SODIUM

Brand Name : IBANDRONATE SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date : 2012-08-15

Application Number : 78996

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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09

DR REDDYS LABS LTD

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DR REDDYS LABS LTD

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Digital Content

RLD : No

TE Code : AB

IBANDRONATE SODIUM

Brand Name : IBANDRONATE SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date : 2012-04-30

Application Number : 78997

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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10

NORVIUM BIOSCIENCE

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NORVIUM BIOSCIENCE

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RLD : No

TE Code :

IBANDRONATE SODIUM

Brand Name : IBANDRONATE SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date : 2012-03-19

Application Number : 78995

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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