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    Chemistry

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    Also known as: 62-54-4, Calcium diacetate, Acetic acid, calcium salt, Lime acetate, Phoslo, Lime pyrolignite
    Molecular Formula
    C4H6CaO4
    Molecular Weight
    158.17  g/mol
    InChI Key
    VSGNNIFQASZAOI-UHFFFAOYSA-L
    FDA UNII
    Y882YXF34X
    Calcium Acetate
    Calcium Acetate is a calcium salt of acetic acid. Calcium is a mineral essential for many cellular functions including nerve impulse transmission, muscle contraction, cardiac function, bone formation, and capillary and cell membrane permeability. Calcium acetate is administered orally to prevent or treat calcium deficiency and to treat hyperphosphatemia due to its phosphate-binding properties.
    1 2D Structure

    Calcium Acetate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    calcium;diacetate
    2.1.2 InChI
    InChI=1S/2C2H4O2.Ca/c2*1-2(3)4;/h2*1H3,(H,3,4);/q;;+2/p-2
    2.1.3 InChI Key
    VSGNNIFQASZAOI-UHFFFAOYSA-L
    2.1.4 Canonical SMILES
    CC(=O)[O-].CC(=O)[O-].[Ca+2]
    2.2 Other Identifiers
    2.2.1 UNII
    Y882YXF34X
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Acetic Acid, Calcium Salt

    2. Acetic Acid, Calcium Salt (2:1)

    3. Phoslo

    2.3.2 Depositor-Supplied Synonyms

    1. 62-54-4

    2. Calcium Diacetate

    3. Acetic Acid, Calcium Salt

    4. Lime Acetate

    5. Phoslo

    6. Lime Pyrolignite

    7. Acetate Of Lime

    8. Brown Acetate

    9. Acetic Acid Calcium Salt

    10. Gray Acetate Of Lime

    11. Brown Acetate Of Lime

    12. Phoslyra

    13. Calcium;diacetate

    14. Calcium Ethanoate

    15. Fema No. 2228

    16. Calcarea Acetica

    17. Calcium(ii) Acetate

    18. Acetic Acid, Calcium Salt (2:1)

    19. Calcium Acetate Anhydrous

    20. Calcium Acetate, Anhydrous

    21. Chebi:3310

    22. Ins No.263

    23. Y882yxf34x

    24. Teltozan

    25. Sorbo-calcion

    26. Vinegar Salts

    27. Gray Acetate

    28. Ins-263

    29. Phoslo Gelcaps

    30. Calcium Di(acetate)

    31. E-263

    32. Ca(oac)2

    33. Eliphos

    34. Sanopan

    35. Ccris 4921

    36. Hsdb 928

    37. Einecs 200-540-9

    38. Calcium Acetate [usp:jan]

    39. Unii-y882yxf34x

    40. Ai3-02903

    41. Calcium Acetate Salt

    42. Phoslo (tn)

    43. Calcium Acetate, Fcc

    44. Calcium Acetate (usp)

    45. Ec 200-540-9

    46. Calcium Acetate 23% 10m

    47. Schembl23872

    48. Calcium Acetate [ii]

    49. Calcium Acetate [mi]

    50. Calcium Acetate [fcc]

    51. Calcium Acetate [fhfi]

    52. Calcium Acetate [hsdb]

    53. Calcium Acetate [inci]

    54. Calcarea Acetica [hpus]

    55. Calcium Acetate [vandf]

    56. Calcium Acetate [mart.]

    57. Chembl1200800

    58. Dtxsid0020234

    59. Calcium Acetate [usp-rs]

    60. Calcium Acetate [who-dd]

    61. Calcium Acetate (fragrance Grade)

    62. Amy23411

    63. Mfcd00012448

    64. Calcium Acetate [orange Book]

    65. Akos015904560

    66. Calcium Acetate [ep Monograph]

    67. Calcium Acetate [usp Monograph]

    68. Db00258

    69. E263

    70. Ft-0623376

    71. Ft-0623377

    72. D00931

    73. Calcium Acetate, Anhydrous [ep Impurity]

    74. Cis,cis-1,3,5-cyclohexanetricarboxylicacid

    75. Q409251

    76. Calcium Diacetate, Cac - Acetic Acid, Calcium Salt

    77. J-519530

    2.4 Create Date
    2005-03-27
    3 Chemical and Physical Properties
    Molecular Weight 158.17 g/mol
    Molecular Formula C4H6CaO4
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count0
    Exact Mass157.9891995 g/mol
    Monoisotopic Mass157.9891995 g/mol
    Topological Polar Surface Area80.3 Ų
    Heavy Atom Count9
    Formal Charge0
    Complexity25.5
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 6  
    Drug NameCalcium acetate
    PubMed HealthCalcium Acetate (By mouth)
    Drug ClassesCalcium Supplement, Phosphate Binder
    Drug LabelEach white, round tablet (stamped CYP910) contains 667 mg calcium acetate, USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium, polyethylene glycol 8000 NF; sodium lauryl sulfate, NF; and crospovidone, NF. ELIPHOS...
    Active IngredientCalcium acetate
    Dosage FormTablet; Capsule
    RouteOral
    Strengtheq 169mg calcium
    Market StatusPrescription
    CompanyAmneal Pharms; Paddock; Invagen Pharms; Roxane

    2 of 6  
    Drug NamePhoslo gelcaps
    Active IngredientCalcium acetate
    Dosage FormCapsule
    RouteOral
    Strengtheq 169mg calcium
    Market StatusPrescription
    CompanyFresenius Medcl

    3 of 6  
    Drug NameProcalamine
    Active Ingredientcalcium acetate; sodium chloride; magnesium acetate; sodium acetate; phosphoric acid; glycerin; potassium chloride; Amino acids
    Dosage FormInjectable
    RouteInjection
    Strength200mg/100ml; 150mg/100ml; 26mg/100ml; 54mg/100ml; 120mg/100ml; 3gm/100ml; 41mg/100ml; 3%
    Market StatusPrescription
    CompanyB Braun

    4 of 6  
    Drug NameCalcium acetate
    PubMed HealthCalcium Acetate (By mouth)
    Drug ClassesCalcium Supplement, Phosphate Binder
    Drug LabelEach white, round tablet (stamped CYP910) contains 667 mg calcium acetate, USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium, polyethylene glycol 8000 NF; sodium lauryl sulfate, NF; and crospovidone, NF. ELIPHOS...
    Active IngredientCalcium acetate
    Dosage FormTablet; Capsule
    RouteOral
    Strengtheq 169mg calcium
    Market StatusPrescription
    CompanyAmneal Pharms; Paddock; Invagen Pharms; Roxane

    5 of 6  
    Drug NamePhoslo gelcaps
    Active IngredientCalcium acetate
    Dosage FormCapsule
    RouteOral
    Strengtheq 169mg calcium
    Market StatusPrescription
    CompanyFresenius Medcl

    6 of 6  
    Drug NameProcalamine
    Active Ingredientcalcium acetate; sodium chloride; magnesium acetate; sodium acetate; phosphoric acid; glycerin; potassium chloride; Amino acids
    Dosage FormInjectable
    RouteInjection
    Strength200mg/100ml; 150mg/100ml; 26mg/100ml; 54mg/100ml; 120mg/100ml; 3gm/100ml; 41mg/100ml; 3%
    Market StatusPrescription
    CompanyB Braun

    4.2 Therapeutic Uses

    ... Used to restrict phosphate absorption in patients with chronic renal failure and oxalate absorption in patients with inflammatory bowel disease.

    Hardman, J.G., L.E. Limbird, P.B. Molinoff, R.W. Ruddon, A.G. Goodman (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 9th ed. New York, NY: McGraw-Hill, 1996., p. 1523

    Calcium acetate is indicated in patients with end-stage renal failure to lower serum phosphate concentrations. It does not promote aluminum absorption. /Included in US product labeling/

    USP. Convention. USPDI - Drug Information for the Health Care Professional. 19th ed. Volume I.Micromedex, Inc. Englewood, CO., 1999. Content Prepared by the U.S. Pharmacopieal Convention, Inc., p. 719

    4.3 Drug Warning

    Except under special circumstances, this medication /calcium acetate/ should not be used when the following medical problem exists: hypercalcemia (calcium acetate may exacerbate the condition).

    USP. Convention. USPDI - Drug Information for the Health Care Professional. 19th ed. Volume I.Micromedex, Inc. Englewood, CO., 1999. Content Prepared by the U.S. Pharmacopieal Convention, Inc., p. 719

    Concurrent use /with digitalis glycosides/ is not recommended because calcium acetate may cause hypercalcemia, which could precipitate cardiac arrhythmias.

    USP. Convention. USPDI - Drug Information for the Health Care Professional. 19th ed. Volume I.Micromedex, Inc. Englewood, CO., 1999. Content Prepared by the U.S. Pharmacopieal Convention, Inc., p. 719

    4.4 Drug Indication

    Calcium acetate is one of a number of calcium salts used to treat hyperphosphatemia (too much phosphate in the blood) in patients with kidney disease.

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Patients with advanced renal insufficiency (creatinine clearance less than 30 ml/min) exhibit phosphate retention and some degree of hyperphosphatemia. The retention of phosphate plays a pivotal role in causing secondary hyperparathyroidism associated with osteodystrophy, and soft-tissue calcification. The mechanism by which phosphate retention leads to hyperparathyroidism is not clearly delineated. Therapeutic efforts directed toward the control of hyperphosphatemia include reduction in the dietary intake of phosphate, inhibition of absorption of phosphate in the intestine with phosphate binders, and removal of phosphate from the body by more efficient methods of dialysis. The rate of removal of phosphate by dietary manipulation or by dialysis is insufficient. Dialysis patients absorb 40% to 80% of dietary phosphorus. Therefore, the fraction of dietary phosphate absorbed from the diet needs to be reduced by using phosphate binders in most renal failure patients on maintenance dialysis. Calcium acetate when taken with meals combines with dietary phosphate to form insoluble calcium phosphate which is excreted in the feces. Maintenance of serum phosphorus below 6.0 mg/dl is generally considered as a clinically acceptable outcome of treatment with phosphate binders. Calcium acetate is highly soluble at neutral pH, making the calcium readily available for binding to phosphate in the proximal small intestine.

    5.2 MeSH Pharmacological Classification

    Chelating Agents

    Chemicals that bind to and remove ions from solutions. Many chelating agents function through the formation of COORDINATION COMPLEXES with METALS. (See all compounds classified as Chelating Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Pharmacological Classes
    Calcium [CS]; Cations, Divalent [CS]; Increased Coagulation Factor Activity [PE]; Blood Coagulation Factor [EPC]
    5.4 ATC Code

    V - Various

    V03 - All other therapeutic products

    V03A - All other therapeutic products

    V03AE - Drugs for treatment of hyperkalemia and hyperphosphatemia

    V03AE07 - Calcium acetate

    5.5 Absorption, Distribution and Excretion

    Absorption

    40% is absorbed in the fasting state and approximately 30% is absorbed in the nonfasting state following oral administration.

    Route of Elimination

    Calcium acetate when taken with meals, combines with dietary phosphate to form insoluble calcium phosphate which is excreted in the feces.

    5.6 Mechanism of Action

    Calcium acetate and other calcium salts are phosphate binders. They work by binding with the phosphate in the food you eat, so that it is eliminated from the body without being absorbed.

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SOLUTIONS","customerCountry":"INDIA","quantity":"324.81","actualQuantity":"324.81","unit":"KGS","unitRateFc":"8.9","totalValueFC":"2918.9","currency":"USD","unitRateINR":"753.8","date":"03-Aug-2024","totalValueINR":"244837.23","totalValueInUsd":"2918.9","indian_port":"JNPT","hs_no":"29152910","bill_no":"4864943","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"MONTREAL","supplierAddress":"100 RUE MC ARTHUR, SUIT 112 VALLEYFIELD QC J6S 4M5 CANADA Quebec - J6S4M5 Canada","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723573800,"product":"CALCIUM ACETATE MONOHYDRATE","address":"PLOT NO.3, EXPORT PROMOTION","city":"","supplier":"AG SCIENTIFIC LLC","supplierCountry":"UNITED STATES","foreign_port":"CHICAGO O\\'HARE INT\\'L","customer":"SENSA CORE MEDICAL ","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"63.7","totalValueFC":"3847.7","currency":"USD","unitRateINR":"6454.8","date":"14-Aug-2024","totalValueINR":"322741.56","totalValueInUsd":"3847.7","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"5059686","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"CHICAGO O\\'HARE INT\\'L","supplierAddress":"9950 SCRIPPS LAKE DRIVE STE 104SAN DIEGO, CALIFORNIASDNF US","customerAddress":"PLOT NO.3, EXPORT PROMOTION"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724178600,"product":"CALCIUM ACETATE PO PH 50KG (PHARMACEUTICAL PRODUCTS)","address":"SITE NO.1,BOMMASANDRA INDL.AREA,IV","city":"ANEKAL TALUK,BANGALORE","supplier":"NIACET B.V","supplierCountry":"NETHERLANDS","foreign_port":"ROTTERDAM","customer":"APOTEX 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SOLUTIONS","customerCountry":"INDIA","quantity":"2603.80","actualQuantity":"2603.795","unit":"KGS","unitRateFc":"8.8","totalValueFC":"23147.4","currency":"USD","unitRateINR":"745","date":"04-Sep-2024","totalValueINR":"1939782.13","totalValueInUsd":"23147.4","indian_port":"JNPT","hs_no":"29152910","bill_no":"5417783","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"MONTREAL","supplierAddress":"100 RUE MC ARTHUR, SUIT 112 VALLEYF IELD QC J6S 4M5 CANADA Quebec - J6S 4M5 Canada Canada","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730226600,"product":"CALCIUM ACETATE (PHARMAAGGLO 50 KG FD 100 UN)","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"MACCO ORGANIQUES INC","supplierCountry":"CANADA","foreign_port":"MONTREAL","customer":"PIRAMAL PHARMA 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SOLUTIONS","customerCountry":"INDIA","quantity":"4500.00","actualQuantity":"4500","unit":"KGS","unitRateFc":"11.4","totalValueFC":"51641.5","currency":"USD","unitRateINR":"968.4","date":"06-Nov-2024","totalValueINR":"4357935","totalValueInUsd":"51641.5","indian_port":"Bombay Air","hs_no":"29152910","bill_no":"6521773","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"MONTREAL, QC","supplierAddress":"100 RUE MC ARTHUR, SUIT 112 VALLEYF IELD QC J6S 4M5 CANADA Quebec - J6S 4M5 Canada","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733855400,"product":"CALCIUM ACETATE PO PH 50KG (BATCH NO: 0008662848) CALCIUM ACETATE PO PH 50KG (BATCH NO 0008662848)","address":"SITE NO.1,BOMMASANDRA INDL.AREA,IV","city":"ANEKAL TALUK,BANGALORE","supplier":"NIACET B.V","supplierCountry":"NETHERLANDS","foreign_port":"ROTTERDAM","customer":"APOTEX INC","customerCountry":"INDIA","quantity":"6600.00","actualQuantity":"6600","unit":"KGS","unitRateFc":"11.5","totalValueFC":"76398.8","currency":"USD","unitRateINR":"983.6","date":"11-Dec-2024","totalValueINR":"6491524.38","totalValueInUsd":"76398.8","indian_port":"Madras Sea","hs_no":"29152910","bill_no":"7164091","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Pharma Grade","supplierPort":"ROTTERDAM","supplierAddress":"PAPESTEEG 91 4006 WC TIEL P.O BOX 60 4000 AB TIEL THE NETHERLANDS NL","customerAddress":"SITE NO.1,BOMMASANDRA INDL.AREA,IV"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734892200,"product":"CALCIUM ACETATE (PHARMA AGGLO 50 KG FD 65 UN) CALCIUM ACETATE (PHARMA AGGLO 50 KG FD 65 UN)","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"MACCO ORGANIQUES INC","supplierCountry":"CANADA","foreign_port":"MONTREAL, QC","customer":"PIRAMAL PHARMA SOLUTIONS","customerCountry":"INDIA","quantity":"3250.00","actualQuantity":"3250","unit":"KGS","unitRateFc":"11.4","totalValueFC":"37313.4","currency":"USD","unitRateINR":"975.5","date":"23-Dec-2024","totalValueINR":"3170480.63","totalValueInUsd":"37313.4","indian_port":"Bombay Air","hs_no":"29152910","bill_no":"7413606","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"MONTREAL, QC","supplierAddress":"100 RUE MC ARTHUR, SUIT 112 VALLEYF IELD QC J6S 4M5 CANADA Quebec - J6S 4M5 Canada","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738953000,"product":"CALCIUM ACETATE PO PH 50KG BATCH NO:0008984858 (100% EOU) CALCIUM ACETATE PO PH 50KG BATCH NO:0008984858 (100% EOU)","address":"SITE NO.1,BOMMASANDRA INDL.AREA,IV","city":"ANEKAL TALUK,BANGALORE","supplier":"NIACET B.V","supplierCountry":"NETHERLANDS","foreign_port":"ROTTERDAM","customer":"APOTEX INC","customerCountry":"INDIA","quantity":"8400.00","actualQuantity":"8400","unit":"KGS","unitRateFc":"10.3","totalValueFC":"87901.8","currency":"N\/A","unitRateINR":"910","date":"08-Feb-2025","totalValueINR":"7644302.48","totalValueInUsd":"87901.8","indian_port":"Madras Sea","hs_no":"29152910","bill_no":"8251502","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Pharma Grade","supplierPort":"ROTTERDAM","supplierAddress":"PAPESTEEG 91 4006 WC TIEL SDNF NETHERLANDS","customerAddress":"SITE NO.1,BOMMASANDRA INDL.AREA,IV"}]
    08-Jan-2021
    08-Feb-2025
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - CAPSULE;ORAL - 667MG

    USFDA APPLICATION NUMBER - 21160

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    DOSAGE - SOLUTION;ORAL - 667MG/5ML

    USFDA APPLICATION NUMBER - 22581

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    ABOUT THIS PAGE

    Looking for 62-54-4 / Calcium Acetate API manufacturers, exporters & distributors?

    Calcium Acetate manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Calcium Acetate 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 Calcium Acetate manufacturer or Calcium Acetate supplier for your needs.

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

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

    API | Excipient name

    Calcium Acetate

    Synonyms

    62-54-4, Calcium diacetate, Acetic acid, calcium salt, Lime acetate, Phoslo, Lime pyrolignite

    Cas Number

    62-54-4

    Unique Ingredient Identifier (UNII)

    Y882YXF34X

    About Calcium Acetate

    Calcium Acetate is a calcium salt of acetic acid. Calcium is a mineral essential for many cellular functions including nerve impulse transmission, muscle contraction, cardiac function, bone formation, and capillary and cell membrane permeability. Calcium acetate is administered orally to prevent or treat calcium deficiency and to treat hyperphosphatemia due to its phosphate-binding properties.

    E263 Manufacturers

    A E263 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of E263, including repackagers and relabelers. The FDA regulates E263 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. E263 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 E263 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    E263 Suppliers

    A E263 supplier is an individual or a company that provides E263 active pharmaceutical ingredient (API) or E263 finished formulations upon request. The E263 suppliers may include E263 API manufacturers, exporters, distributors and traders.

    click here to find a list of E263 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    E263 USDMF

    A E263 DMF (Drug Master File) is a document detailing the whole manufacturing process of E263 active pharmaceutical ingredient (API) in detail. Different forms of E263 DMFs exist exist since differing nations have different regulations, such as E263 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A E263 DMF submitted to regulatory agencies in the US is known as a USDMF. E263 USDMF includes data on E263's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The E263 USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of E263 suppliers with USDMF on PharmaCompass.

    E263 CEP

    A E263 CEP of the European Pharmacopoeia monograph is often referred to as a E263 Certificate of Suitability (COS). The purpose of a E263 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of E263 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of E263 to their clients by showing that a E263 CEP has been issued for it. The manufacturer submits a E263 CEP (COS) as part of the market authorization procedure, and it takes on the role of a E263 CEP holder for the record. Additionally, the data presented in the E263 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the E263 DMF.

    A E263 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. E263 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 E263 suppliers with CEP (COS) on PharmaCompass.

    E263 WC

    A E263 written confirmation (E263 WC) is an official document issued by a regulatory agency to a E263 manufacturer, verifying that the manufacturing facility of a E263 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting E263 APIs or E263 finished pharmaceutical products to another nation, regulatory agencies frequently require a E263 WC (written confirmation) as part of the regulatory process.

    click here to find a list of E263 suppliers with Written Confirmation (WC) on PharmaCompass.

    E263 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 E263 as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for E263 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 E263 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 E263 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a E263 NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of E263 suppliers with NDC on PharmaCompass.

    E263 GMP

    E263 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 E263 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 E263 GMP manufacturer or E263 GMP API supplier for your needs.

    E263 CoA

    A E263 CoA (Certificate of Analysis) is a formal document that attests to E263's compliance with E263 specifications and serves as a tool for batch-level quality control.

    E263 CoA mostly includes findings from lab analyses of a specific batch. For each E263 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.

    E263 may be tested according to a variety of international standards, such as European Pharmacopoeia (E263 EP), E263 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (E263 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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