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    Chemistry

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    Also known as: 127-09-3, Acetic acid, sodium salt, Sodium acetate anhydrous, Acetic acid sodium salt, Sodium acetate, anhydrous, Anhydrous sodium acetate
    Molecular Formula
    C2H3NaO2
    Molecular Weight
    82.03  g/mol
    InChI Key
    VMHLLURERBWHNL-UHFFFAOYSA-M
    FDA UNII
    NVG71ZZ7P0
    Sodium Acetate
    The trihydrate sodium salt of acetic acid, which is used as a source of sodium ions in solutions for dialysis and as a systemic and urinary alkalizer, diuretic, and expectorant.
    1 2D Structure

    Sodium Acetate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    sodium;acetate
    2.1.2 InChI
    InChI=1S/C2H4O2.Na/c1-2(3)4;/h1H3,(H,3,4);/q;+1/p-1
    2.1.3 InChI Key
    VMHLLURERBWHNL-UHFFFAOYSA-M
    2.1.4 Canonical SMILES
    CC(=O)[O-].[Na+]
    2.2 Other Identifiers
    2.2.1 UNII
    NVG71ZZ7P0
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Sodium Acetate Trihydrate

    2. Sodium Acetate, Anhydrous

    2.3.2 Depositor-Supplied Synonyms

    1. 127-09-3

    2. Acetic Acid, Sodium Salt

    3. Sodium Acetate Anhydrous

    4. Acetic Acid Sodium Salt

    5. Sodium Acetate, Anhydrous

    6. Anhydrous Sodium Acetate

    7. Sodium Ethanoate

    8. Fema No. 3024

    9. Sodium-acetate

    10. Acetic Acid, Sodium Salt (1:1)

    11. Sodium;acetate

    12. Mfcd00012459

    13. Natriumacetat

    14. Sodium Acetate,anhydrous

    15. Nvg71zz7p0

    16. Chebi:32954

    17. Sodii Acetas

    18. Natriumazetat

    19. Nsc-77459

    20. Natrium Aceticum

    21. Octan Sodny [czech]

    22. Caswell No. 741a

    23. Natriumacetat [german]

    24. Chembl1354

    25. Fema Number 3024

    26. Octan Sodny

    27. Naoac

    28. Hsdb 688

    29. Sodium Acetate In Plastic Container

    30. Einecs 204-823-8

    31. Nsc 77459

    32. Unii-nvg71zz7p0

    33. Epa Pesticide Chemical Code 044006

    34. Sodiumacetate

    35. Sodium Aceate

    36. Acona

    37. Scfa

    38. Ch3coona

    39. Acetic Acidsodium Salt

    40. Sodium Acetate Solution

    41. Short Chain Fatty Acids

    42. Sodium Acetate ,(s)

    43. Ch3co2na

    44. Dsstox_cid_7044

    45. Ec 204-823-8

    46. Dsstox_rid_78290

    47. Sodium Acetate [mi]

    48. Dsstox_gsid_27044

    49. Sodium Acetate, Acs Reagent

    50. Sodium Acetate [fhfi]

    51. Sodium Acetate [hsdb]

    52. Dtxsid2027044

    53. Sodium Acetate [who-dd]

    54. Sodium Acetate Solution, 0.3 M

    55. Sodium Acetate, Biochemical Grade

    56. Sodium Acetate Anhydrous Acs Usp

    57. Tox21_202741

    58. Sodium Acetate Anhydrous [ii]

    59. Akos003052995

    60. Akos015837569

    61. Sodium Acetate, Bioxtra, >=99.0%

    62. Db09395

    63. Sodium Acetate, Reagentplus(r), 99%

    64. Sodium Acetate, For Hplc, >=99.5%

    65. Sodium Acetate,anhydrous [vandf]

    66. Acetate, 1m Buffer Solution, Ph, 3.0

    67. Acetate, 1m Buffer Solution, Ph, 3.5

    68. Acetate, 1m Buffer Solution, Ph, 4.0

    69. Acetate, 1m Buffer Solution, Ph, 5.0

    70. Acetate, 1m Buffer Solution, Ph, 5.5

    71. Ncgc00260289-01

    72. Sodium Acetate, Ar, Anhydrous, >=99%

    73. Sodium Acetate, Lr, Anhydrous, >=98%

    74. Cas-127-09-3

    75. E262

    76. Sodium Acetate, Acs Reagent, >=99.0%

    77. B7296

    78. Ft-0635282

    79. Ft-0659959

    80. Ft-0689166

    81. S0559

    82. Sodium Acetate Anhydrous, >99%, Fcc, Fg

    83. Sodium Acetate Anhydrous [orange Book]

    84. Sodium Acetate, 99.995% Trace Metals Basis

    85. Sodium Acetate, Saj First Grade, >=98.0%

    86. Sodium Acetate, Trace Metals Grade, 99.99%

    87. Sodium Acetate Anhydrous Acs Grade 12kg

    88. Sodium Acetate, Jis Special Grade, >=98.5%

    89. Sodium Acetate, Vetec(tm) Reagent Grade, 98%

    90. Sodium Acetate Anhydrous [usp Monograph]

    91. A805637

    92. Q339940

    93. J-005463

    94. Sodium Acetate, For Hplc, 99.0-101.0% (nt)

    95. Sodium Acetate, Puriss., Anhydrous, >=98%, Powder

    96. Sodium Acetate, Anhydrous, Reagentplus(r), >=99.0%

    97. Sodium Acetate, Anhydrous, For Molecular Biology, >=99%

    98. Sodium Acetate, For Electrophoresis, >=99%, Crystalline

    99. Sodium Acetate, 1m Aqueous Solution, Ph 4.5, Rnase Free

    100. Sodium Acetate, 3m Aqueous Solution, Ph 4.5, Autoclaved

    101. Sodium Acetate, 3m Aqueous Solution, Ph 5.2, Autoclaved

    102. Sodium Acetate, 3m Aqueous Solution, Ph 5.2, Rnase Free

    103. Sodium Acetate, 3m Aqueous Solution, Ph 7.0, Autoclaved

    104. Sodium Acetate, 3m Aqueous Solution, Ph 7.0, Rnase Free

    105. Sodium Acetate, Meets Usp Testing Specifications, Anhydrous

    106. Sodium Acetate, United States Pharmacopeia (usp) Reference Standard

    107. Sodium Acetate Solution, Bioultra, For Molecular Biology, ~3 M In H2o

    108. Sodium Acetate, Bioultra, For Luminescence, Anhydrous, >=99.0% (nt)

    109. Sodium Acetate, Puriss. P.a., Acs Reagent, Reag. Ph. Eur., Anhydrous

    110. Sodium Acetate, Anhydrous, Bioultra, For Luminescence, For Molecular Biology, >=99.0% (nt)

    111. Sodium Acetate, Anhydrous, Free-flowing, Redi-dri(tm), Acs Reagent, >=99.0%

    112. Mettler-toledo Calibration Substance Me 30130599, Sodium Acetate Anhydrous, Tracable To Primary Standards (lgc)

    113. Sodium Acetate Solution, Nmr Reference Standard, 50 Mm In D2o (99.9 Atom % D), Water 1 %, Nmr Tube Size 3 Mm X 8 In.

    114. Sodium Acetate, Powder, Bioreagent, For Electrophoresis, Suitable For Cell Culture, Suitable For Insect Cell Culture, >=99%

    2.4 Create Date
    2005-03-27
    3 Chemical and Physical Properties
    Molecular Weight 82.03 g/mol
    Molecular Formula C2H3NaO2
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count2
    Rotatable Bond Count0
    Exact Mass82.00307362 g/mol
    Monoisotopic Mass82.00307362 g/mol
    Topological Polar Surface Area40.1 Ų
    Heavy Atom Count5
    Formal Charge0
    Complexity34.6
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameSodium acetate in plastic container
    Active IngredientSodium acetate anhydrous
    Dosage FormInjectable
    RouteInjection
    Strength2meq/ml
    Market StatusPrescription
    CompanyHospira

    2 of 2  
    Drug NameSodium acetate in plastic container
    Active IngredientSodium acetate anhydrous
    Dosage FormInjectable
    RouteInjection
    Strength2meq/ml
    Market StatusPrescription
    CompanyHospira

    4.2 Therapeutic Uses

    Diuretics; Expectorants; Pharmaceutic Aids

    National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)

    /FORMER USE/: HYOSCYAMUS SODIUM ACETATE, & PHENOBARBITAL ELIXIR COMBINES SMOOTH MUSCLE ANTISPASMODIC ACTION OF ... HYOSCYAMUS, WITH URINARY ALKALINIZING & DIURETIC EFFECTS OF SODIUM ACETATE, & SEDATIVE EFFECTS OF PHENOBARBITAL. /IT IS/ USED IN MANAGEMENT OF CYSTITIS & FOR BLADDER IRRITATION.

    American Hospital Formulary Service. Volumes I and II. Washington, DC: American Society of Hospital Pharmacists, to 1984., p. 86:00

    DOSAGE OF ELIXIR OF HYOSCYAMUS CMPD /CONTAINING SODIUM ACETATE & PHENOBARBITAL/ IS 5 ML GIVEN 3 TIMES DAILY BEFORE MEALS.

    American Hospital Formulary Service. Volumes I and II. Washington, DC: American Society of Hospital Pharmacists, to 1984., p. 86:00

    ... /SODIUM ACETATE/ HAS BEEN USED FOR PARENTERAL THERAPY OF ACIDOTIC CONDITIONS. IT IS BOTH A SYSTEMIC & URINARY ALKALIZER. /SODIUM ACETATE TRIHYDRATE, USP/

    Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 772

    For more Therapeutic Uses (Complete) data for SODIUM ACETATE (8 total), please visit the HSDB record page.

    4.3 Drug Indication

    Injection, USP 40 mEq is indicated as a source of sodium, for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. Sodium acetate and other bicarbonate precursors are alkalinising agents, and can be used to correct metabolic acidosis, or for alkalinisation of the urine.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Sodium is the principal cation of extracellular fluid. It comprises more than 90% of total cations at its normal plasma concentration of approximately 140 mEq/liter. The sodium ion exerts a primary role in controlling total body water and its distribution. Acetate ions acts as hydrogen ion acceptor which is alternative to bicarbonate.

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Increased Large Intestinal Motility [PE]
    5.3 ATC Code

    B - Blood and blood forming organs

    B05 - Blood substitutes and perfusion solutions

    B05X - I.v. solution additives

    B05XA - Electrolyte solutions

    B05XA08 - Sodium acetate

    5.4 Absorption, Distribution and Excretion

    Absorption

    It is readily available in the circulation after IV administration.

    Route of Elimination

    Both the sodium and bicarbonate ions are excreted mainly in the urine. Some sodium is excreted in the feces, and small amounts may also be excreted in saliva, sweat, bile and pancreatic secretions.

    5.5 Metabolism/Metabolites

    In liver, sodium acetate is being metabolized into bicarbonate. To form bicarbonate, acetate is slowly hydrolyzed to carbon dioxide and water, which are then converted to bicarbonate by the addition of a hydrogen ion.

    THE ACETATE ION IS RAPIDLY & COMPLETELY METABOLIZED BY BODY, & CONSEQUENTLY ADMIN OF SODIUM ACETATE IS EVENTUALLY EQUIVALENT TO GIVING SODIUM BICARBONATE. /SODIUM ACETATE TRIHYDRATE, USP/

    Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 772

    CONSTANT RATE INFUSIONS OF SODIUM ACETATE GIVEN TO VOLUNTEERS, AT 4 MMOL/KG/HR INCR PLASMA ACETATE BY ONLY 0.41 MMOL/L, INDICATING A HIGH ACETATE METABOLIZING CAPACITY IN MAN.

    KVEIM MH R ET AL; J OSLO CITY HOSP: 30 (8): 101 (1980)

    Readily metabolized outside the liver.

    American Medical Association. AMA Drug Evaluations Annual 1991. Chicago, IL: American Medical Association, 1991., p. 723

    5.6 Mechanism of Action

    It works as a source of sodium ions especially in cases of hyponatremic patients. Sodium has a primary role in regulating extracellular fluid volume. It controls water distribution, fluid and electrolyte balance and the osmotic pressure of body fluids. Sodium is also involved in nerve conduction, muscle contraction, acid-base balance and cell nutrient uptake.

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250, 64293 Darm stadt,(BENEFICIARY MERCKFINANCIALS SERVICES GMBH) GERMANY","customerAddress":"50A , RING ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1772130600,"product":"SODIUM ACETATE TRIHYDRATE EMPROVE EXPERT PH EUR,BP,CHP,JP,USP 12PCS X 1KG (PHARMA GRADE)ORGANIC CHEMICAL","address":"50A , RING ROAD,","city":"BANGALORE, KARNATAKA","supplier":"MERCK LIFE SCIENCE KGAA","supplierCountry":"CHINA","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MERCK LIFE SCIENCE PRIVATE LTD","customerCountry":"INDIA","quantity":"12.00","actualQuantity":"12","unit":"KGS","unitRateFc":"53.9","totalValueFC":"654.9","currency":"N\/A","unitRateINR":"4953.9","date":"27-Feb-2026","totalValueINR":"59446.29","totalValueInUsd":"654.9","indian_port":"Bombay Air","hs_no":"29152990","bill_no":"8450115","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"Frankfurter Strasse 250, 64293 Darm stadt,(BENEFICIARY MERCKFINANCIALS SERVICES GMBH) GERMANY","customerAddress":"50A , RING ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1772217000,"product":"SODIUM ACETATE ANHYDROUS EMPROVE EXPERT CHP,USP 3PCS X 25KG(PHARMA GRADE)ORGANIC CHEMICAL","address":"50A , RING ROAD,","city":"BANGALORE, KARNATAKA","supplier":"MERCK LIFE SCIENCE KGAA","supplierCountry":"CHINA","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MERCK LIFE SCIENCE PRIVATE LTD","customerCountry":"INDIA","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"29.2","totalValueFC":"2219.7","currency":"N\/A","unitRateINR":"2686.4","date":"28-Feb-2026","totalValueINR":"201481.16","totalValueInUsd":"2219.7","indian_port":"Bombay Air","hs_no":"29152990","bill_no":"6","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"Frankfurter Strasse 250, 64293 Darm stadt,(BENEFICIARY MERCKFINANCIALS SERVICES GMBH) GERMANY","customerAddress":"50A , RING ROAD,"}]
    06-Jan-2022
    28-Feb-2026
    KGS
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    Average Price (USD/KGS)

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100...DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML)

    USFDA APPLICATION NUMBER - 200656

    read-more

    DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100...DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML)

    USFDA APPLICATION NUMBER - 200656

    read-more

    DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100...DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML)

    USFDA APPLICATION NUMBER - 200656

    read-more

    DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100...DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML)

    USFDA APPLICATION NUMBER - 200656

    read-more

    DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100...DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML)

    USFDA APPLICATION NUMBER - 200656

    read-more

    DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100...DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML)

    USFDA APPLICATION NUMBER - 200656

    read-more

    DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100...DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML)

    USFDA APPLICATION NUMBER - 200656

    read-more

    DOSAGE - SOLUTION;IRRIGATION - 0.48MG/ML;0.3M...DOSAGE - SOLUTION;IRRIGATION - 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML

    USFDA APPLICATION NUMBER - 20742

    read-more

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    ABOUT THIS PAGE

    Looking for 127-09-3 / Sodium Acetate API manufacturers, exporters & distributors?

    Sodium Acetate manufacturers, exporters & distributors 1

    59

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

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

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

    API | Excipient name

    Sodium Acetate

    Synonyms

    127-09-3, Acetic acid, sodium salt, Sodium acetate anhydrous, Acetic acid sodium salt, Sodium acetate, anhydrous, Anhydrous sodium acetate

    Cas Number

    127-09-3

    Unique Ingredient Identifier (UNII)

    NVG71ZZ7P0

    About Sodium Acetate

    The trihydrate sodium salt of acetic acid, which is used as a source of sodium ions in solutions for dialysis and as a systemic and urinary alkalizer, diuretic, and expectorant.

    KABIVEN IN PLASTIC CONTAINER-5 Manufacturers

    A KABIVEN IN PLASTIC CONTAINER-5 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of KABIVEN IN PLASTIC CONTAINER-5, including repackagers and relabelers. The FDA regulates KABIVEN IN PLASTIC CONTAINER-5 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. KABIVEN IN PLASTIC CONTAINER-5 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 KABIVEN IN PLASTIC CONTAINER-5 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    KABIVEN IN PLASTIC CONTAINER-5 Suppliers

    A KABIVEN IN PLASTIC CONTAINER-5 supplier is an individual or a company that provides KABIVEN IN PLASTIC CONTAINER-5 active pharmaceutical ingredient (API) or KABIVEN IN PLASTIC CONTAINER-5 finished formulations upon request. The KABIVEN IN PLASTIC CONTAINER-5 suppliers may include KABIVEN IN PLASTIC CONTAINER-5 API manufacturers, exporters, distributors and traders.

    click here to find a list of KABIVEN IN PLASTIC CONTAINER-5 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    KABIVEN IN PLASTIC CONTAINER-5 USDMF

    A KABIVEN IN PLASTIC CONTAINER-5 DMF (Drug Master File) is a document detailing the whole manufacturing process of KABIVEN IN PLASTIC CONTAINER-5 active pharmaceutical ingredient (API) in detail. Different forms of KABIVEN IN PLASTIC CONTAINER-5 DMFs exist exist since differing nations have different regulations, such as KABIVEN IN PLASTIC CONTAINER-5 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A KABIVEN IN PLASTIC CONTAINER-5 DMF submitted to regulatory agencies in the US is known as a USDMF. KABIVEN IN PLASTIC CONTAINER-5 USDMF includes data on KABIVEN IN PLASTIC CONTAINER-5's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The KABIVEN IN PLASTIC CONTAINER-5 USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of KABIVEN IN PLASTIC CONTAINER-5 suppliers with USDMF on PharmaCompass.

    KABIVEN IN PLASTIC CONTAINER-5 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 KABIVEN IN PLASTIC CONTAINER-5 Drug Master File in Japan (KABIVEN IN PLASTIC CONTAINER-5 JDMF) empowers KABIVEN IN PLASTIC CONTAINER-5 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 KABIVEN IN PLASTIC CONTAINER-5 JDMF during the approval evaluation for pharmaceutical products. At the time of KABIVEN IN PLASTIC CONTAINER-5 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 KABIVEN IN PLASTIC CONTAINER-5 suppliers with JDMF on PharmaCompass.

    KABIVEN IN PLASTIC CONTAINER-5 KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a KABIVEN IN PLASTIC CONTAINER-5 Drug Master File in Korea (KABIVEN IN PLASTIC CONTAINER-5 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of KABIVEN IN PLASTIC CONTAINER-5. The MFDS reviews the KABIVEN IN PLASTIC CONTAINER-5 KDMF as part of the drug registration process and uses the information provided in the KABIVEN IN PLASTIC CONTAINER-5 KDMF to evaluate the safety and efficacy of the drug.

    After submitting a KABIVEN IN PLASTIC CONTAINER-5 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 KABIVEN IN PLASTIC CONTAINER-5 API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of KABIVEN IN PLASTIC CONTAINER-5 suppliers with KDMF on PharmaCompass.

    KABIVEN IN PLASTIC CONTAINER-5 WC

    A KABIVEN IN PLASTIC CONTAINER-5 written confirmation (KABIVEN IN PLASTIC CONTAINER-5 WC) is an official document issued by a regulatory agency to a KABIVEN IN PLASTIC CONTAINER-5 manufacturer, verifying that the manufacturing facility of a KABIVEN IN PLASTIC CONTAINER-5 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting KABIVEN IN PLASTIC CONTAINER-5 APIs or KABIVEN IN PLASTIC CONTAINER-5 finished pharmaceutical products to another nation, regulatory agencies frequently require a KABIVEN IN PLASTIC CONTAINER-5 WC (written confirmation) as part of the regulatory process.

    click here to find a list of KABIVEN IN PLASTIC CONTAINER-5 suppliers with Written Confirmation (WC) on PharmaCompass.

    KABIVEN IN PLASTIC CONTAINER-5 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 KABIVEN IN PLASTIC CONTAINER-5 as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for KABIVEN IN PLASTIC CONTAINER-5 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 KABIVEN IN PLASTIC CONTAINER-5 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 KABIVEN IN PLASTIC CONTAINER-5 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a KABIVEN IN PLASTIC CONTAINER-5 NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of KABIVEN IN PLASTIC CONTAINER-5 suppliers with NDC on PharmaCompass.

    KABIVEN IN PLASTIC CONTAINER-5 GMP

    KABIVEN IN PLASTIC CONTAINER-5 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 KABIVEN IN PLASTIC CONTAINER-5 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 KABIVEN IN PLASTIC CONTAINER-5 GMP manufacturer or KABIVEN IN PLASTIC CONTAINER-5 GMP API supplier for your needs.

    KABIVEN IN PLASTIC CONTAINER-5 CoA

    A KABIVEN IN PLASTIC CONTAINER-5 CoA (Certificate of Analysis) is a formal document that attests to KABIVEN IN PLASTIC CONTAINER-5's compliance with KABIVEN IN PLASTIC CONTAINER-5 specifications and serves as a tool for batch-level quality control.

    KABIVEN IN PLASTIC CONTAINER-5 CoA mostly includes findings from lab analyses of a specific batch. For each KABIVEN IN PLASTIC CONTAINER-5 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.

    KABIVEN IN PLASTIC CONTAINER-5 may be tested according to a variety of international standards, such as European Pharmacopoeia (KABIVEN IN PLASTIC CONTAINER-5 EP), KABIVEN IN PLASTIC CONTAINER-5 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (KABIVEN IN PLASTIC CONTAINER-5 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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