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    Also known as: Sodium risedronate, 115436-72-1, Actonel, Atelvia, Risedronate (sodium), Ne 58095
    Molecular Formula
    C7H10NNaO7P2
    Molecular Weight
    305.09  g/mol
    InChI Key
    DRFDPXKCEWYIAW-UHFFFAOYSA-M
    FDA UNII
    OFG5EXG60L
    Risedronate Sodium
    A pyridine and diphosphonic acid derivative that acts as a CALCIUM CHANNEL BLOCKER and inhibits BONE RESORPTION.
    1 2D Structure

    Risedronate Sodium

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    sodium;hydroxy-(1-hydroxy-1-phosphono-2-pyridin-3-ylethyl)phosphinate
    2.1.2 InChI
    InChI=1S/C7H11NO7P2.Na/c9-7(16(10,11)12,17(13,14)15)4-6-2-1-3-8-5-6;/h1-3,5,9H,4H2,(H2,10,11,12)(H2,13,14,15);/q;+1/p-1
    2.1.3 InChI Key
    DRFDPXKCEWYIAW-UHFFFAOYSA-M
    2.1.4 Canonical SMILES
    C1=CC(=CN=C1)CC(O)(P(=O)(O)O)P(=O)(O)[O-].[Na+]
    2.2 Other Identifiers
    2.2.1 UNII
    OFG5EXG60L
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    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

    2.3.2 Depositor-Supplied Synonyms

    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

    2.4 Create Date
    2005-09-13
    3 Chemical and Physical Properties
    Molecular Weight 305.09 g/mol
    Molecular Formula C7H10NNaO7P2
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count4
    Exact Mass304.98301994 g/mol
    Monoisotopic Mass304.98301994 g/mol
    Topological Polar Surface Area151 Ų
    Heavy Atom Count18
    Formal Charge0
    Complexity375
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 6  
    Drug NameActonel
    PubMed HealthAntacid, Calcium Containing (By mouth)
    Drug ClassesAntacid, Aluminum Containing, Antacid, Aluminum/Calcium/Magnesium Containing, Antacid, Calcium Containing, Antacid, Magnesium Containing, Antiflatulent, Calcium Supplement
    Drug LabelACTONEL (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 IngredientRisedronate sodium
    Dosage FormTablet
    RouteOral
    Strength5mg; 30mg; 150mg; 35mg
    Market StatusPrescription
    CompanyWarner Chilcott

    2 of 6  
    Drug NameAtelvia
    Drug LabelAtelvia (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 IngredientRisedronate sodium
    Dosage FormTablet, delayed release
    RouteOral
    Strength35mg
    Market StatusPrescription
    CompanyWarner Chilcott

    3 of 6  
    Drug NameRisedronate sodium
    PubMed HealthRisedronate (By mouth)
    Drug ClassesCalcium Regulator
    Drug LabelACTONEL (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 IngredientRisedronate sodium
    Dosage FormTablet
    Routeoral; Oral
    Strength30mg; 150mg; 75mg; 5mg; 35mg
    Market StatusTentative Approval; Prescription
    CompanyMylan Pharms; Apotex; Aurobindo Pharma; Teva Pharms Usa; Sun Pharma Global; Teva Pharms

    4 of 6  
    Drug NameActonel
    PubMed HealthAntacid, Calcium Containing (By mouth)
    Drug ClassesAntacid, Aluminum Containing, Antacid, Aluminum/Calcium/Magnesium Containing, Antacid, Calcium Containing, Antacid, Magnesium Containing, Antiflatulent, Calcium Supplement
    Drug LabelACTONEL (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 IngredientRisedronate sodium
    Dosage FormTablet
    RouteOral
    Strength5mg; 30mg; 150mg; 35mg
    Market StatusPrescription
    CompanyWarner Chilcott

    5 of 6  
    Drug NameAtelvia
    Drug LabelAtelvia (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 IngredientRisedronate sodium
    Dosage FormTablet, delayed release
    RouteOral
    Strength35mg
    Market StatusPrescription
    CompanyWarner Chilcott

    6 of 6  
    Drug NameRisedronate sodium
    PubMed HealthRisedronate (By mouth)
    Drug ClassesCalcium Regulator
    Drug LabelACTONEL (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 IngredientRisedronate sodium
    Dosage FormTablet
    Routeoral; Oral
    Strength30mg; 150mg; 75mg; 5mg; 35mg
    Market StatusTentative Approval; Prescription
    CompanyMylan Pharms; Apotex; Aurobindo Pharma; Teva Pharms Usa; Sun Pharma Global; Teva Pharms

    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.)

    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.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Bisphosphonate [EPC]; Diphosphonates [CS]; Bisphosphonate [EPC]

    API Reference Price

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HIGHWAY,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1709749800,"product":"RISEDRONATE SODIUM USP (REJECTED RETURN CARGO VIDE SBNO.1512627DT.03-JUN-23)","address":"SHYAM-ARIHANT,3RD FLOOR, PNO.10,11","city":"SECUNDERABAD,TELANGANA","supplier":"ALTHAIA S\/A INDUSTRIA ","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"SHIVA\\'S FARMA CASA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"80.00","actualQuantity":"80","unit":"KGS","unitRateFc":"725","totalValueFC":"58603.6","currency":"USD","unitRateINR":"60827.5","date":"07-Mar-2024","totalValueINR":"4866200","totalValueInUsd":"58603.6","indian_port":"Hyderabad Air","hs_no":"29209000","bill_no":"2466343","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"GUARULHOS","supplierAddress":"RUA LUCY VASCONCELOS TEIXERIA 100BAIRRO MIRANTE DO PARAISO POUSO ALE-GRE MG, CNPJ : 48.344.725\/0008-08 BR","customerAddress":"SHYAM-ARIHANT,3RD FLOOR, PNO.10,11"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1709749800,"product":"RISEDRONATE SODIUM USP (REJECTED RETURN CARGO VIDE SBNO.5232847DT.08-NOV-23)","address":"SHYAM-ARIHANT,3RD FLOOR, PNO.10,11","city":"SECUNDERABAD,TELANGANA","supplier":"ALTHAIA S\/A INDUSTRIA ","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"SHIVA\\'S FARMA CASA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"13.00","actualQuantity":"13","unit":"KGS","unitRateFc":"725","totalValueFC":"9523.1","currency":"USD","unitRateINR":"60827.5","date":"07-Mar-2024","totalValueINR":"790757.5","totalValueInUsd":"9523.1","indian_port":"Hyderabad Air","hs_no":"29209000","bill_no":"2466343","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"GUARULHOS","supplierAddress":"RUA LUCY VASCONCELOS TEIXERIA 100BAIRRO MIRANTE DO PARAISO POUSO ALE-GRE MG, CNPJ : 48.344.725\/0008-08 BR","customerAddress":"SHYAM-ARIHANT,3RD FLOOR, PNO.10,11"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1709749800,"product":"RISEDRONATE SODIUM USP (REJECTED RETURN CARGO VIDE SBNO.8188474DT.02-MAR-23)","address":"SHYAM-ARIHANT,3RD FLOOR, PNO.10,11","city":"SECUNDERABAD,TELANGANA","supplier":"ALTHAIA S\/A INDUSTRIA ","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"SHIVA\\'S FARMA CASA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"725","totalValueFC":"14650.9","currency":"USD","unitRateINR":"60827.5","date":"07-Mar-2024","totalValueINR":"1216550","totalValueInUsd":"14650.9","indian_port":"Hyderabad Air","hs_no":"29209000","bill_no":"2466343","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"GUARULHOS","supplierAddress":"RUA LUCY VASCONCELOS TEIXERIA 100BAIRRO MIRANTE DO PARAISO POUSO ALE-GRE MG, CNPJ : 48.344.725\/0008-08 BR","customerAddress":"SHYAM-ARIHANT,3RD FLOOR, PNO.10,11"}]
    18-Jan-2021
    28-Jan-2025
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 150MG

    USFDA APPLICATION NUMBER - 20835

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    DOSAGE - TABLET;ORAL - 30MG

    USFDA APPLICATION NUMBER - 20835

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    DOSAGE - TABLET;ORAL - 35MG

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    DOSAGE - TABLET;ORAL - 5MG

    USFDA APPLICATION NUMBER - 20835

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    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

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    DOSAGE - TABLET, DELAYED RELEASE;ORAL - 35MG

    USFDA APPLICATION NUMBER - 22560

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    ABOUT THIS PAGE

    Looking for 115436-72-1 / Risedronate Sodium API manufacturers, exporters & distributors?

    Risedronate Sodium manufacturers, exporters & distributors 1

    53

    PharmaCompass offers a list of Risedronate Sodium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Risedronate Sodium manufacturer or Risedronate Sodium supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Risedronate Sodium manufacturer or Risedronate Sodium supplier.

    PharmaCompass also assists you with knowing the Risedronate Sodium API Price utilized in the formulation of products. Risedronate Sodium API Price is not always fixed or binding as the Risedronate Sodium Price is obtained through a variety of data sources. The Risedronate Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Risedronate Sodium

    Synonyms

    Sodium risedronate, 115436-72-1, Actonel, Atelvia, Risedronate (sodium), Ne 58095

    Cas Number

    115436-72-1

    Unique Ingredient Identifier (UNII)

    OFG5EXG60L

    About Risedronate Sodium

    A pyridine and diphosphonic acid derivative that acts as a CALCIUM CHANNEL BLOCKER and inhibits BONE RESORPTION.

    Risedronate (sodium) Manufacturers

    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.

    Risedronate (sodium) Suppliers

    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.

    Risedronate (sodium) USDMF

    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.

    Risedronate (sodium) JDMF

    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.

    Risedronate (sodium) KDMF

    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.

    Risedronate (sodium) CEP

    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.

    Risedronate (sodium) WC

    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.

    Risedronate (sodium) NDC

    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).

    Finished drug products

    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.

    Unfinished drugs

    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.

    Compounded drug products

    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) GMP

    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.

    Risedronate (sodium) CoA

    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).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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