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1. 1-hydroxy-2-(3-pyridyl)ethylidene Diphosphonate
2. 2-(3-pyridinyl)-1-hydroxyethylidene-bisphosphonate
3. 2-(3-pyridinyl)-1-hydroxyethylidenebisphosphonate
4. Actonel
5. Atelvia
6. Bisphosphonate Risedronate Sodium
7. Risedronate
8. Risedronate Sodium, Bisphosphonate
9. Risedronic Acid
10. Risedronic Acid, Monosodium Salt
11. Sodium, Bisphosphonate Risedronate
1. Sodium Risedronate
2. 115436-72-1
3. Actonel
4. Atelvia
5. Risedronate (sodium)
6. Ne 58095
7. Risedronic Acid Monosodium Salt
8. Risedronate Monosodium
9. Ofg5exg60l
10. Risedronate Sodium Anhydrous
11. Ne-58095 Anhydrous
12. Sodium Trihydrogen (1-hydroxy-2-(3-pyridyl)ethylidene)diphosphonate
13. 115436-72-1 (sodium)
14. Risedronic Acid Sodium
15. Benet
16. Nsc-722598
17. Nsc-759280
18. Actonel (tn)
19. Phosphonic Acid, (1-hydroxy-2-(3-pyridinyl)ethylidene)bis-, Monosodium Salt
20. Sodium Hydrogen (1-hydroxy-1-phosphono-2-(pyridin-3-yl)ethyl)phosphonate
21. Risedronate Sodium [usan]
22. Risedronic Acid Sodium Salt
23. Mfcd00867080
24. 122458-82-6
25. Unii-ofg5exg60l
26. Optinate
27. Acrel
28. Risedronate Sodium [usan:usp]
29. Sodium Hydrogen [1-hydroxy-1-phosphono-2-(pyridin-3-yl)ethyl]phosphonate
30. Optinate Septimum
31. Monosodium Risedronate
32. Monosodium (1-hydroxy-2-(3-pyridinyl)ethylidene)bisphosphonate
33. Ne 58095 Sodium
34. Risedronate Sodium (usp)
35. Chembl1654
36. Schembl18377
37. Risedronate Sodium, Min 97%
38. Chebi:8868
39. Dtxsid20924178
40. Risedronate Sodium [vandf]
41. Risedronate Sodium [mart.]
42. Act03362
43. Bcp22742
44. Hy-b0119
45. Risedronate Sodium [usp-rs]
46. Risedronate Sodium [who-dd]
47. Ac-732
48. Mfcd01706268
49. S1428
50. Akos015833432
51. Ab09807
52. Ccg-213235
53. Cs-1883
54. Nsc 722598
55. Nsc 759280
56. Risedronate Sodium [orange Book]
57. Ncgc00346521-01
58. Ac-20120
59. As-13309
60. Risedronate Sodium [usp Monograph]
61. Ft-0631078
62. M2289
63. Risedronic Acid Monosodium Salt [mi]
64. D00942
65. H11438
66. Ab01274790-01
67. Q-201723
68. Q27285633
69. 2-(3-pyridinyl)-2-hydroxyethylidene-1,1-bisphosphonate
70. Monosodium 1-hydroxy-2-(3-pyridyl)ethylidene-1,1-diphosphonate
71. 1-hydroxy-2-(3-pyridinyl) Ethylidene Bis-phosphonic Acid Monosodium Salt
72. Hydrogen [1-hydroxy-1-phosphono-2-(pyridin-3-yl)ethyl]phosphonate (na+)
73. P,p'-[1-hydroxy-2-(3-pyridonyl)ethylidene]bis-phosphonic Acid Sodium Salt
74. Phosphonic Acid, (1-hydroxy-2-(3-pyridinyl)ethylidene)bis-, Disodium Salt
75. Phosphonic Acid, (2-hydroxy-2-(3-pyridinyl)ethylidene)bis-, Disodium Salt
76. Risedronate Sodium, United States Pharmacopeia (usp) Reference Standard
77. Risedronate Sodium;risedronic Acid Sodium;ne-58095; Ne 58095; Ne58095
78. Sodium Hydrogen-1-hydroxy-1-phosphono-2-(pyridin-3-yl)ethylphosphonate
79. Sodium;hydroxy-(1-hydroxy-1-phosphono-2-pyridin-3-ylethyl)phosphinate
80. (1-hydroxy-2-(pyridin-3-yl)ethane-1,1-diyl)bis(phosphonic Acid) Sodium Salt
81. Risedronate Sodium 2.5-hydrate, European Pharmacopoeia (ep) Reference Standard
82. Risedronate Sodium, Pharmaceutical Secondary Standard; Certified Reference Material
83. 934544-85-1
| Molecular Weight | 305.09 g/mol |
|---|---|
| Molecular Formula | C7H10NNaO7P2 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 8 |
| Rotatable Bond Count | 4 |
| Exact Mass | 304.98301994 g/mol |
| Monoisotopic Mass | 304.98301994 g/mol |
| Topological Polar Surface Area | 151 Ų |
| Heavy Atom Count | 18 |
| Formal Charge | 0 |
| Complexity | 375 |
| 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 6 | |
|---|---|
| Drug Name | Actonel |
| PubMed Health | Antacid, Calcium Containing (By mouth) |
| Drug Classes | Antacid, Aluminum Containing, Antacid, Aluminum/Calcium/Magnesium Containing, Antacid, Calcium Containing, Antacid, Magnesium Containing, Antiflatulent, Calcium Supplement |
| Drug Label | ACTONEL (risedronate sodium) tablets is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each ACTONEL tablet for oral administration contains the equivalent of 5, 30, 35, 75, or 150 mg of anh... |
| Active Ingredient | Risedronate sodium |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 5mg; 30mg; 150mg; 35mg |
| Market Status | Prescription |
| Company | Warner Chilcott |
| 2 of 6 | |
|---|---|
| Drug Name | Atelvia |
| Drug Label | Atelvia (risedronate sodium) delayed-release tablets contain a pH-sensitive enteric coating and a chelating agent (EDTA). Risedronate is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each... |
| Active Ingredient | Risedronate sodium |
| Dosage Form | Tablet, delayed release |
| Route | Oral |
| Strength | 35mg |
| Market Status | Prescription |
| Company | Warner Chilcott |
| 3 of 6 | |
|---|---|
| Drug Name | Risedronate sodium |
| PubMed Health | Risedronate (By mouth) |
| Drug Classes | Calcium Regulator |
| Drug Label | ACTONEL (risedronate sodium) tablets is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each ACTONEL tablet for oral administration contains the equivalent of 5, 30, 35, 75, or 150 mg of anh... |
| Active Ingredient | Risedronate sodium |
| Dosage Form | Tablet |
| Route | oral; Oral |
| Strength | 30mg; 150mg; 75mg; 5mg; 35mg |
| Market Status | Tentative Approval; Prescription |
| Company | Mylan Pharms; Apotex; Aurobindo Pharma; Teva Pharms Usa; Sun Pharma Global; Teva Pharms |
| 4 of 6 | |
|---|---|
| Drug Name | Actonel |
| PubMed Health | Antacid, Calcium Containing (By mouth) |
| Drug Classes | Antacid, Aluminum Containing, Antacid, Aluminum/Calcium/Magnesium Containing, Antacid, Calcium Containing, Antacid, Magnesium Containing, Antiflatulent, Calcium Supplement |
| Drug Label | ACTONEL (risedronate sodium) tablets is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each ACTONEL tablet for oral administration contains the equivalent of 5, 30, 35, 75, or 150 mg of anh... |
| Active Ingredient | Risedronate sodium |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 5mg; 30mg; 150mg; 35mg |
| Market Status | Prescription |
| Company | Warner Chilcott |
| 5 of 6 | |
|---|---|
| Drug Name | Atelvia |
| Drug Label | Atelvia (risedronate sodium) delayed-release tablets contain a pH-sensitive enteric coating and a chelating agent (EDTA). Risedronate is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each... |
| Active Ingredient | Risedronate sodium |
| Dosage Form | Tablet, delayed release |
| Route | Oral |
| Strength | 35mg |
| Market Status | Prescription |
| Company | Warner Chilcott |
| 6 of 6 | |
|---|---|
| Drug Name | Risedronate sodium |
| PubMed Health | Risedronate (By mouth) |
| Drug Classes | Calcium Regulator |
| Drug Label | ACTONEL (risedronate sodium) tablets is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each ACTONEL tablet for oral administration contains the equivalent of 5, 30, 35, 75, or 150 mg of anh... |
| Active Ingredient | Risedronate sodium |
| Dosage Form | Tablet |
| Route | oral; Oral |
| Strength | 30mg; 150mg; 75mg; 5mg; 35mg |
| Market Status | Tentative Approval; Prescription |
| Company | Mylan Pharms; Apotex; Aurobindo Pharma; Teva Pharms Usa; Sun Pharma Global; Teva Pharms |
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.)
Calcium Channel Blockers
A class of drugs that act by selective inhibition of calcium influx through cellular membranes. (See all compounds classified as Calcium Channel Blockers.)
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DOSAGE - TABLET;ORAL - 150MG
USFDA APPLICATION NUMBER - 20835
DOSAGE - TABLET;ORAL - 30MG
USFDA APPLICATION NUMBER - 20835
DOSAGE - TABLET;ORAL - 35MG
USFDA APPLICATION NUMBER - 20835
DOSAGE - TABLET;ORAL - 5MG
USFDA APPLICATION NUMBER - 20835
DOSAGE - TABLET;ORAL - 75MG **Federal Registe...DOSAGE - TABLET;ORAL - 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20835
DOSAGE - TABLET, DELAYED RELEASE;ORAL - 35MG
USFDA APPLICATION NUMBER - 22560
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ABOUT THIS PAGE
A Risedronate Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Risedronate Sodium, including repackagers and relabelers. The FDA regulates Risedronate Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Risedronate Sodium 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 Risedronate Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Risedronate Sodium supplier is an individual or a company that provides Risedronate Sodium active pharmaceutical ingredient (API) or Risedronate Sodium finished formulations upon request. The Risedronate Sodium suppliers may include Risedronate Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Risedronate Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Risedronate Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Risedronate Sodium active pharmaceutical ingredient (API) in detail. Different forms of Risedronate Sodium DMFs exist exist since differing nations have different regulations, such as Risedronate Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Risedronate Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Risedronate Sodium USDMF includes data on Risedronate Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Risedronate Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Risedronate Sodium 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 Risedronate Sodium Drug Master File in Japan (Risedronate Sodium JDMF) empowers Risedronate Sodium 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 Risedronate Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Risedronate Sodium 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 Risedronate Sodium 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 Risedronate Sodium Drug Master File in Korea (Risedronate Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Risedronate Sodium. The MFDS reviews the Risedronate Sodium KDMF as part of the drug registration process and uses the information provided in the Risedronate Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Risedronate Sodium 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 Risedronate Sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Risedronate Sodium suppliers with KDMF on PharmaCompass.
A Risedronate Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Risedronate Sodium Certificate of Suitability (COS). The purpose of a Risedronate Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Risedronate Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Risedronate Sodium to their clients by showing that a Risedronate Sodium CEP has been issued for it. The manufacturer submits a Risedronate Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Risedronate Sodium CEP holder for the record. Additionally, the data presented in the Risedronate Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Risedronate Sodium DMF.
A Risedronate Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Risedronate Sodium 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 Risedronate Sodium suppliers with CEP (COS) on PharmaCompass.
A Risedronate Sodium written confirmation (Risedronate Sodium WC) is an official document issued by a regulatory agency to a Risedronate Sodium manufacturer, verifying that the manufacturing facility of a Risedronate Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Risedronate Sodium APIs or Risedronate Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Risedronate Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Risedronate Sodium 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 Risedronate Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Risedronate Sodium 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 Risedronate Sodium 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 Risedronate Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Risedronate Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Risedronate Sodium suppliers with NDC on PharmaCompass.
Risedronate Sodium 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 Risedronate Sodium 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 Risedronate Sodium GMP manufacturer or Risedronate Sodium GMP API supplier for your needs.
A Risedronate Sodium CoA (Certificate of Analysis) is a formal document that attests to Risedronate Sodium's compliance with Risedronate Sodium specifications and serves as a tool for batch-level quality control.
Risedronate Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Risedronate Sodium 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.
Risedronate Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Risedronate Sodium EP), Risedronate Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Risedronate Sodium USP).
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