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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
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
Molecular Weight | 341.21 g/mol |
---|---|
Molecular Formula | C9H22NNaO7P2 |
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 Ų |
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 |
1 of 4 | |
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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 |
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.
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.)
M05BA06
M05BA06
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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ABOUT THIS PAGE
A Ibandronic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ibandronic Acid, including repackagers and relabelers. The FDA regulates Ibandronic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ibandronic Acid API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Ibandronic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ibandronic Acid supplier is an individual or a company that provides Ibandronic Acid active pharmaceutical ingredient (API) or Ibandronic Acid finished formulations upon request. The Ibandronic Acid suppliers may include Ibandronic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Ibandronic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ibandronic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Ibandronic Acid active pharmaceutical ingredient (API) in detail. Different forms of Ibandronic Acid DMFs exist exist since differing nations have different regulations, such as Ibandronic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ibandronic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Ibandronic Acid USDMF includes data on Ibandronic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ibandronic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ibandronic Acid suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Ibandronic Acid Drug Master File in Japan (Ibandronic Acid JDMF) empowers Ibandronic Acid API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Ibandronic Acid JDMF during the approval evaluation for pharmaceutical products. At the time of Ibandronic Acid JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Ibandronic Acid suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ibandronic Acid Drug Master File in Korea (Ibandronic Acid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ibandronic Acid. The MFDS reviews the Ibandronic Acid KDMF as part of the drug registration process and uses the information provided in the Ibandronic Acid KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ibandronic Acid KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Ibandronic Acid API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ibandronic Acid suppliers with KDMF on PharmaCompass.
A Ibandronic Acid CEP of the European Pharmacopoeia monograph is often referred to as a Ibandronic Acid Certificate of Suitability (COS). The purpose of a Ibandronic Acid CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ibandronic Acid EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ibandronic Acid to their clients by showing that a Ibandronic Acid CEP has been issued for it. The manufacturer submits a Ibandronic Acid CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ibandronic Acid CEP holder for the record. Additionally, the data presented in the Ibandronic Acid CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ibandronic Acid DMF.
A Ibandronic Acid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ibandronic Acid CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Ibandronic Acid suppliers with CEP (COS) on PharmaCompass.
A Ibandronic Acid written confirmation (Ibandronic Acid WC) is an official document issued by a regulatory agency to a Ibandronic Acid manufacturer, verifying that the manufacturing facility of a Ibandronic Acid active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ibandronic Acid APIs or Ibandronic Acid finished pharmaceutical products to another nation, regulatory agencies frequently require a Ibandronic Acid WC (written confirmation) as part of the regulatory process.
click here to find a list of Ibandronic Acid suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Ibandronic Acid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ibandronic Acid API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Ibandronic Acid as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Ibandronic Acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ibandronic Acid NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ibandronic Acid suppliers with NDC on PharmaCompass.
Ibandronic Acid Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Ibandronic Acid GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Ibandronic Acid GMP manufacturer or Ibandronic Acid GMP API supplier for your needs.
A Ibandronic Acid CoA (Certificate of Analysis) is a formal document that attests to Ibandronic Acid's compliance with Ibandronic Acid specifications and serves as a tool for batch-level quality control.
Ibandronic Acid CoA mostly includes findings from lab analyses of a specific batch. For each Ibandronic Acid CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Ibandronic Acid may be tested according to a variety of international standards, such as European Pharmacopoeia (Ibandronic Acid EP), Ibandronic Acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ibandronic Acid USP).
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