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    Chemistry

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    Also known as: Sodium hydrogen carbonate, 144-55-8, Baking soda, Sodium hydrogencarbonate, Sodium acid carbonate, Carbonic acid monosodium salt
    Molecular Formula
    CHNaO3
    Molecular Weight
    84.007  g/mol
    InChI Key
    UIIMBOGNXHQVGW-UHFFFAOYSA-M
    FDA UNII
    8MDF5V39QO
    Sodium Bicarbonate
    A white, crystalline powder that is commonly used as a pH buffering agent, an electrolyte replenisher, systemic alkalizer and in topical cleansing solutions.
    1 2D Structure

    Sodium Bicarbonate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    sodium;hydrogen carbonate
    2.1.2 InChI
    InChI=1S/CH2O3.Na/c2-1(3)4;/h(H2,2,3,4);/q;+1/p-1
    2.1.3 InChI Key
    UIIMBOGNXHQVGW-UHFFFAOYSA-M
    2.1.4 Canonical SMILES
    C(=O)(O)[O-].[Na+]
    2.2 Other Identifiers
    2.2.1 UNII
    8MDF5V39QO
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Baking Soda

    2. Bicarbonate, Sodium

    3. Carbonic Acid Monosodium Salt

    4. Hydrogen Carbonate, Sodium

    5. Soda, Baking

    6. Sodium Hydrogen Carbonate

    2.3.2 Depositor-Supplied Synonyms

    1. Sodium Hydrogen Carbonate

    2. 144-55-8

    3. Baking Soda

    4. Sodium Hydrogencarbonate

    5. Sodium Acid Carbonate

    6. Carbonic Acid Monosodium Salt

    7. Bicarbonate Of Soda

    8. Sodium Hydrocarbonate

    9. Monosodium Carbonate

    10. Meylon

    11. Acidosan

    12. Neut

    13. Natriumhydrogenkarbonat

    14. Nahco3

    15. Natrum Bicarbonicum

    16. Jusonin

    17. Soludal

    18. Soda Mint

    19. Soda (van)

    20. Carbonic Acid Sodium Salt (1:1)

    21. Monosodium Hydrogen Carbonate

    22. Nabic

    23. Mfcd00003528

    24. Sodium Hydrogencarbonat

    25. Hydrocerol Esc 5671

    26. Carbonic Acid, Monosodium Salt

    27. Genitron Tp-bch 51051

    28. Sodium Bicarbonate Anhydrous

    29. 8mdf5v39qo

    30. E500

    31. Ins No.500(ii)

    32. Chebi:32139

    33. Ins-500(ii)

    34. Col-evac

    35. Sel De Vichy

    36. E-500(ii)

    37. Nsc-134031

    38. Natrium Bicarbonicum

    39. Natrii Hydrogencarbonas

    40. E 500

    41. E-500

    42. Natrium Hydrogencarbonicum

    43. Sodium Hydrogen-carbonate

    44. Caswell No. 747

    45. Sodium Carbonate (na(hco3))

    46. Sodium Bicarbonate (1:1)

    47. Sodium Bicarbonate In Plastic Container

    48. Meylon (tn)

    49. Ccris 3064

    50. Hsdb 697

    51. Neut (tn)

    52. Sodium;hydrogen Carbonate

    53. Einecs 205-633-8

    54. Sodium Bicarbonate Solution

    55. Unii-8mdf5v39qo

    56. Epa Pesticide Chemical Code 073505

    57. Nsc 134031

    58. Sodium Bicarbonate [usp:jan]

    59. Sodium Bicabonate

    60. Sodium Bicarbonat

    61. Bicarbonate Sodium

    62. Sodium-bicarbonate

    63. Sodiumbi-carbonate

    64. Sodium Bi-carbonate

    65. Sodium Bicarbonate-

    66. Sodium Bi Carbonate

    67. Natriumhydrogencarbonat

    68. Sodium Hydrogencabonate

    69. Sodium;hydron;carbonate

    70. Sodiumhydrogen Carbonate

    71. Natrii Hydrogenocarbonas

    72. Sodium Hydrogen Cabonate

    73. Hydrogen Carbonate Sodium

    74. Sodium Bicarbonate, Usp

    75. Sodium Hyd-rogencarbonate

    76. Sodium-hydrogen-carbonate

    77. Sodium Hydrogen Carboante

    78. Sodium Bicarboniate

    79. Ec 205-633-8

    80. Chembl1353

    81. B1654 [langual]

    82. Sodium Bicarbonate [ii]

    83. Sodium Bicarbonate [mi]

    84. Dtxsid9021269

    85. Sodium Bicarbonate [fcc]

    86. Sodium Bicarbonate [jan]

    87. Sodium Bicarbonate (jp17/usp)

    88. Sodium Bicarbonate [hsdb]

    89. Sodium Bicarbonate [inci]

    90. Sodium Hydrogen Carbonate Solution

    91. Natrum Bicarbonicum [hpus]

    92. Sodium Bicarbonate [vandf]

    93. Sodium Bicarbonate [mart.]

    94. Amy40219

    95. Sodium Bicarbonate [usp-rs]

    96. Sodium Bicarbonate [who-dd]

    97. Str00078

    98. Sodium Bicarbonate -40-+140 Mesh

    99. Sodium Bicarbonate, Biochemical Grade

    100. Akos015836321

    101. Akos015951222

    102. Sodium Hydrogen Carbonate, Puratronic?

    103. Db01390

    104. Sodium Bicarbonate [orange Book]

    105. Baros Component Sodium Bicarbonate

    106. Sodium Bicarbonate A.c.s. Reagent Grade

    107. Sodium Bicarbonate [usp Monograph]

    108. Bicarbonate, 1m Buffer Solution, Ph 8.0

    109. Bicarbonate, 1m Buffer Solution, Ph 8.5

    110. Sodium Hydrogen Carbonate [who-ip]

    111. Zegerid Component Sodium Bicarbonate

    112. B7292

    113. Ft-0645108

    114. Normocarb Component Sodium Bicarbonate

    115. S0561

    116. Sodium Bicarbonate Component Of Baros

    117. Halflytely Component Sodium Bicarbonate

    118. Sodium Bicarbonate Component Of Zegerid

    119. D01203

    120. Natrii Hydrogenocarbonas [who-ip Latin]

    121. 3-phenyl-2-thioxotetrahydropyrimidin-4(1h)-one

    122. Sodium Bicarbonate Component Of Halflytely

    123. Sodium Bicarbonate Component Of Normocarb

    124. Sodium Bicarbonate, 1m Buffer Solution, Ph 8.0

    125. Sodium Bicarbonate, 1m Buffer Solution, Ph 9.0

    126. Sodium Hydrogen Carbonate [ep Monograph]

    127. Q179731

    128. Sodium Bicarbonate, 1m Buffer Solution, Ph 10.0

    129. Sodium Bicarbonate, Hplc, Meets Acs Specifications

    130. Sodium Bicarbonate 5% W/v Solution In Water (+/- 0.3%)

    131. Saturated Aqueous Sodium Bicarbonate Solution (~9.6% Wt/wt)

    2.4 Create Date
    2005-03-27
    3 Chemical and Physical Properties
    Molecular Weight 84.007 g/mol
    Molecular Formula CHNaO3
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count0
    Exact Mass83.98233817 g/mol
    Monoisotopic Mass83.98233817 g/mol
    Topological Polar Surface Area60.4 Ų
    Heavy Atom Count5
    Formal Charge0
    Complexity33.9
    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 8  
    Drug NameBss plus
    Active Ingredientsodium chloride; sodium phosphate; magnesium chloride; potassium chloride; glutathione disulfide; sodium bicarbonate; dextrose; Calcium chloride
    Dosage FormSolution
    RouteIrrigation
    Strength0.2mg/ml; 0.38mg/ml; 0.184mg/ml; 0.92mg/ml; 2.1mg/ml; 0.154mg/ml; 0.42mg/ml; 7.14mg/ml
    Market StatusPrescription
    CompanyAlcon

    2 of 8  
    Drug NameGolytely
    PubMed HealthSodium Bicarbonate
    Drug ClassesAntacid, Sodium Bicarbonate Containing
    Active Ingredientsodium chloride; sodium bicarbonate; Polyethylene glycol 3350; sodium sulfate anhydrous; potassium chloride
    Dosage FormFor solution
    RouteOral
    Strength5.86gm/bot; 227.1gm/packet; 6.74gm/bot; 2.82gm/packet; 22.74gm/bot; 21.5gm/packet; 2.97gm/bot; 5.53gm/packet; 6.36gm/packet; 236gm/bot
    Market StatusPrescription
    CompanyBraintree

    3 of 8  
    Drug NameNulytely
    Active Ingredientsodium chloride; sodium bicarbonate; Polyethylene glycol 3350; potassium chloride
    Dosage FormFor solution
    RouteOral
    Strength420gm/bot; 1.48gm/bot; 11.2gm/bot; 5.72gm/bot
    Market StatusPrescription
    CompanyBraintree

    4 of 8  
    Drug NameSodium bicarbonate
    PubMed HealthPolyethylene Glycol 3350, Sodium and Potassium Salts (Oral route)
    Drug ClassesLaxative, Hyperosmotic
    Drug LabelSodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer.Solutions are off...
    Active IngredientSodium bicarbonate
    Dosage FormInjectable
    RouteInjection
    Strength0.9meq/ml; 1meq/ml
    Market StatusPrescription
    CompanyHospira

    5 of 8  
    Drug NameBss plus
    Active Ingredientsodium chloride; sodium phosphate; magnesium chloride; potassium chloride; glutathione disulfide; sodium bicarbonate; dextrose; Calcium chloride
    Dosage FormSolution
    RouteIrrigation
    Strength0.2mg/ml; 0.38mg/ml; 0.184mg/ml; 0.92mg/ml; 2.1mg/ml; 0.154mg/ml; 0.42mg/ml; 7.14mg/ml
    Market StatusPrescription
    CompanyAlcon

    6 of 8  
    Drug NameGolytely
    PubMed HealthSodium Bicarbonate
    Drug ClassesAntacid, Sodium Bicarbonate Containing
    Active Ingredientsodium chloride; sodium bicarbonate; Polyethylene glycol 3350; sodium sulfate anhydrous; potassium chloride
    Dosage FormFor solution
    RouteOral
    Strength5.86gm/bot; 227.1gm/packet; 6.74gm/bot; 2.82gm/packet; 22.74gm/bot; 21.5gm/packet; 2.97gm/bot; 5.53gm/packet; 6.36gm/packet; 236gm/bot
    Market StatusPrescription
    CompanyBraintree

    7 of 8  
    Drug NameNulytely
    Active Ingredientsodium chloride; sodium bicarbonate; Polyethylene glycol 3350; potassium chloride
    Dosage FormFor solution
    RouteOral
    Strength420gm/bot; 1.48gm/bot; 11.2gm/bot; 5.72gm/bot
    Market StatusPrescription
    CompanyBraintree

    8 of 8  
    Drug NameSodium bicarbonate
    PubMed HealthPolyethylene Glycol 3350, Sodium and Potassium Salts (Oral route)
    Drug ClassesLaxative, Hyperosmotic
    Drug LabelSodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer.Solutions are off...
    Active IngredientSodium bicarbonate
    Dosage FormInjectable
    RouteInjection
    Strength0.9meq/ml; 1meq/ml
    Market StatusPrescription
    CompanyHospira

    4.2 Therapeutic Uses

    Sodium bicarbonate is used in the treatment of metabolic acidosis associated with many conditions including severe renal disease (e.g., renal tubular acidosis), uncontrolled diabetes (ketoacidosis), extracorporeal circulation of the blood, cardiac arrest, circulatory insufficiency caused by shock or severe dehydration, ureterosigmoidostomy, lactic acidosis, alcoholic ketoacidosis, use of carbonic anhydrase inhibitors, and ammonium chloride administration. In metabolic acidosis, the principal disturbance is a loss of proton acceptors (e.g., loss of bicarbonate during severe diarrhea) or accumulation of an acid load (e.g., ketoacidosis, lactic acidosis, renal tubular acidosis).

    American Society of Health-System Pharmacists 2017; Drug Information 2017. Bethesda, MD. 2017, p. 2852

    The specific role of sodium bicarbonate therapy in the treatment of diabetic ketoacidosis has not been established. Because correction of the underlying metabolic disorder generally results in correction of acid-base abnormalities and because of the potential risks of sodium bicarbonate therapy in the treatment of this disorder, administration of sodium bicarbonate is generally reserved for the treatment of severe acidosis (e.g., arterial pH less than 7-7.15 or serum bicarbonate concentration of 8 mEq/L or less). Rapid correction of acidosis with sodium bicarbonate in patients with diabetic ketoacidosis may cause hypokalemia, paradoxical acidosis in cerebrospinal fluid (CSF) since carbon dioxide diffuses more rapidly into CSF than does bicarbonate, and lactic acidosis since increased pH increases hemoglobin-oxygen affinity which, when combined with erythrocyte 2,3-diphosphoglycerate (2,3-DPG) deficiency in these patients, results in peripheral tissue hypoxia. However, the benefits and risks of sodium bicarbonate therapy in ketoacidosis have not been fully determined, and additional controlled studies of the safety and efficacy of the drug are necessary. Generally, when sodium bicarbonate is used in the treatment of diabetic ketoacidosis, the acidosis should only be partially corrected (e.g., to an arterial pH of about 7.2) to avoid rebound metabolic alkalosis as ketones are metabolized.

    American Society of Health-System Pharmacists 2017; Drug Information 2017. Bethesda, MD. 2017, p. 2852

    Oral sodium bicarbonate is indicated to reduce uric acid crystallization as an adjuvant to uricosuric medication in gout. /Included in US product labeling/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.

    Parenteral sodium bicarbonate is indicated in the treatment of certain drug intoxications, including barbiturates, and in poisoning by salicylates or methyl alcohol. /Included in US product labeling/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.

    For more Therapeutic Uses (Complete) data for Sodium bicarbonate (29 total), please visit the HSDB record page.

    4.3 Drug Warning

    Sodium bicarbonate is generally contraindicated in patients with metabolic or respiratory alkalosis, in patients with hypocalcemia in whom alkalosis may induce tetany, in patients with excessive chloride loss from vomiting or continuous GI suctioning, and in patients at risk of developing diuretic-induced hypochloremic alkalosis. Sodium bicarbonate should not be used orally as an antidote in the treatment of acute ingestion of strong mineral acids, since carbon dioxide gas forms during neutralization and may cause gastric distention and possible rupture.

    American Society of Health-System Pharmacists 2017; Drug Information 2017. Bethesda, MD. 2017, p. 2853

    Sodium bicarbonate should be used with extreme caution in patients with congestive heart failure or other edematous or sodium-retaining conditions; in patients with renal insufficiency, especially those with severe insufficiency such as oliguria or anuria; and in patients receiving corticosteroids or corticotropin, since each gram of sodium bicarbonate contains about 12 mEq of sodium. IV administration of sodium bicarbonate may cause fluid and/or solute overload resulting in dilution of serum electrolytes, overhydration, congestive conditions, or pulmonary edema. The risk of dilutional conditions is inversely proportional to the electrolyte concentration administered, and the risk of solute overload and resultant congestive conditions with peripheral and/or pulmonary edema is directly proportional to the electrolyte concentration administered.

    American Society of Health-System Pharmacists 2017; Drug Information 2017. Bethesda, MD. 2017, p. 2853

    Gastric distention and flatulence may occur when sodium bicarbonate is administered orally. Inadvertent extravasation of hypertonic solutions of sodium bicarbonate has reportedly caused chemical cellulitis because of their alkalinity, subsequently resulting in tissue necrosis, ulceration, and/or sloughing at the site of injection.

    American Society of Health-System Pharmacists 2017; Drug Information 2017. Bethesda, MD. 2017, p. 2853

    Predisposing factors /contributing to milk-alkali syndrome/ are preexisting hypertension, sarcoidosis, dehydration and electrolyte imbalance due to vomiting or aspiration of gastric contents with inadequate iv fluid replacement, and renal dysfunction caused by primary renal disease.

    American Medical Association, Council on Drugs. AMA Drug Evaluations Annual 1994. Chicago, IL: American Medical Association, 1994., p. 909

    For more Drug Warnings (Complete) data for Sodium bicarbonate (14 total), please visit the HSDB record page.

    4.4 Drug Indication

    Sodium bicarbonate is used for the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturateprotein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of blood pigments.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Intravenous sodium bicarbonate therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH and reverses the clinical manifestations of acidosis.

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

    B - Blood and blood forming organs

    B05 - Blood substitutes and perfusion solutions

    B05C - Irrigating solutions

    B05CB - Salt solutions

    B05CB04 - Sodium bicarbonate

    B - Blood and blood forming organs

    B05 - Blood substitutes and perfusion solutions

    B05X - I.v. solution additives

    B05XA - Electrolyte solutions

    B05XA02 - Sodium bicarbonate

    5.4 Absorption, Distribution and Excretion

    Elimination: Renal; carbon dioxide formed is eliminated via lungs.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.

    Excess sodium bicarbonate is emptied rapidly into small intestine where it is absorbed.

    Miller, R. R., and D. J. Greenblatt. Handbook of Drug Therapy. New York: Elsevier North Holland, 1979., p. 1043

    It is eliminated principally in the urine and effectively alkalizes it. ... /It/ is completely absorbed orally and usually is excreted within 3-4 hr.

    American Medical Association, AMA Department of Drugs. AMA Drug Evaluations. 4th ed. Chicago: American Medical Association, 1980., p. 1440

    Oral: Onset of action: Rapid; Duration: 8-10 minutes. I.V: Onset of action: 15 minutes; duration: 1-2 hours.

    Lelkin, J.B., Paloucek, F.P., Poisoning & Toxicology Compendium. LEXI-COMP Inc. & American Pharmaceutical Association, Hudson, OH 1998., p. 1079

    For more Absorption, Distribution and Excretion (Complete) data for Sodium bicarbonate (8 total), please visit the HSDB record page.

    5.5 Metabolism/Metabolites

    Excessive use can cause systemic alkalosis /in animals/, but body usually splits bicarbonate radical into water and carbon dioxide ...

    Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 533

    Sodium bicarbonate rapidly reacts with hydrochloric acid to form sodium chloride, carbon dioxide, and water; excess bicarbonate that does not neutralize gastric acid rapidly empties into the small intestine and is absorbed.

    McEvoy, G.K. (ed.). American Hospital Formulary Service--Drug Information 94. Bethesda, MD: American Society of Hospital Pharmacists, Inc. 1994 (Plus Supplements)., p. 1870

    5.6 Mechanism of Action

    Sodium bicarbonate is a systemic alkalizer, which increases plasma bicarbonate, buffers excess hydrogen ion concentration, and raises blood pH, thereby reversing the clinical manifestations of acidosis. It is also a urinary alkalizer, increasing the excretion of free bicarbonate ions in the urine, thus effectively raising the urinary pH. By maintaining an alkaline urine, the actual dissolution of uric acid stones may be accomplished. Sodium bicarbonate acts as an antacid and reacts chemically to neutralize or buffer existing quantities of stomach acid but has no direct effect on its output. This action results in increased pH value of stomach contents, thus providing relief of hyperacidity symptoms. [PharmGKB]

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    Emnar Pharma

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    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    MAGHREB PHARMA
    Not Confirmed
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    Emnar Pharma

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    MAGHREB PHARMA
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-06-24

    Pay. Date : 2021-05-17

    DMF Number : 32436

    Submission : 2018-01-19

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    06

    SAFC

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    MAGHREB PHARMA
    Not Confirmed
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    SAFC

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    MAGHREB PHARMA
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16457

    Submission : 2003-02-28

    Status : Inactive

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 230MF40003

    Registrant's Address : 13804 West 107th Street Lenexa, Kansas 66215 USA

    Initial Date of Registration : 2018-01-15

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    07

    SAFC

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    MAGHREB PHARMA
    Not Confirmed
    arrow

    SAFC

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    MAGHREB PHARMA
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19557

    Submission : 2006-05-29

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    08

    SAFC

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    MAGHREB PHARMA
    Not Confirmed
    arrow

    SAFC

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    MAGHREB PHARMA
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19772

    Submission : 2006-09-01

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    09

    SAFC

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    MAGHREB PHARMA
    Not Confirmed
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    SAFC

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    MAGHREB PHARMA
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21368

    Submission : 2008-02-01

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    10

    SAFC

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    MAGHREB PHARMA
    Not Confirmed
    arrow

    SAFC

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    MAGHREB PHARMA
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21545

    Submission : 2008-03-31

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Only 10 entries up to this point, click to access all click full view read-more
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    EU WC

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    01

    Emnar Pharma

    India
    Cophex
    Not Confirmed
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    Emnar Pharma

    India
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    Cophex
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Sodium Bicarbonate USP

    Date of Issue : 2020-05-20

    Valid Till : 2023-02-01

    Written Confirmation Number : WC-0392

    Address of the Firm : Unit II Plot No.15 Jawaharlal Nehru Pharma City, Tadi V Parawada M Visakhapatnam...

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    02

    Sun Pharmaceutical Industries Limited

    India
    Cophex
    Not Confirmed
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    Sun Pharmaceutical Industries Limited

    India
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    Cophex
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Sodium Bicarbonate Sterile IH

    Date of Issue : 2022-07-06

    Valid Till : 2025-07-04

    Written Confirmation Number : WC-0216

    Address of the Firm : Industrial Area-3, A. B. Road, Dewas (M.P.)-455001

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    API Reference Price

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    [{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1695148200,"product":"CEPHALOTHIN SODIUM BUFFERED STERILE USP(CEPHALOTHIN SODIUM WITH SODIUM BICARBONATE FOR INJECTABLE FORMULATION (STERILE)","address":"ORCHID TOWERS,313,VALLUVARKOTTAMHIGH ROAD,NUNGAMBAKKAM","city":"CHENNAI","supplier":"ORCHID PHARMA LIMITED","supplierCountry":"INDIA","foreign_port":"BOGOTA","customer":"VITALIS","customerCountry":"COLOMBIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"175","totalValueFC":"33575","currency":"USD","unitRateINR":13935,"date":"20-Sep-2023","totalValueINR":"2787000","totalValueInUsd":"33575","indian_port":"Madras Air","hs_no":"29419090","bill_no":"4048073","productDescription":"API","marketType":"","country":"COLOMBIA","selfForZScoreResived":"Sterile","supplierPort":"Madras Air","supplierAddress":"ORCHID TOWERS,313,VALLUVARKOTTAMHIGH ROAD,NUNGAMBAKKAM, CHENNAI","customerAddress":""},{"dataSource":"API 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Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1710873000,"product":"CEPHALOTHIN SODIUM BUFFERED STERILE USP(CEPHALOTHIN SODIUM WITH SODIUM BICARBONATE FOR INJECTABLE FORMULATION STERILE","address":"ORCHID TOWERS,313,VALLUVARKOTTAMHIGH ROAD,NUNGAMBAKKAM","city":"CHENNAI","supplier":"ORCHID PHARMA LIMITED","supplierCountry":"INDIA","foreign_port":"BOGOTA","customer":"VITALIS S A C I,830.068.119-1","customerCountry":"COLOMBIA","quantity":"190.00","actualQuantity":"190","unit":"KGS","unitRateFc":"173","totalValueFC":"30754.5","currency":"USD","unitRateINR":13440.660105263158,"date":"20-Mar-2024","totalValueINR":"2553725.42","totalValueInUsd":"30754.5","indian_port":"Madras Air","hs_no":"29419090","bill_no":"8481189","productDescription":"API","marketType":"","country":"COLOMBIA","selfForZScoreResived":"Sterile","supplierPort":"Madras Air","supplierAddress":"ORCHID TOWERS,313,VALLUVARKOTTAMHIGH ROAD,NUNGAMBAKKAM, CHENNAI","customerAddress":""},{"dataSource":"API 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Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729449000,"product":"CEPHALOTIN SODIUM BUFFERED STERILE (CEPHALOTHIN SODIUM WITH SODIUM BICARBONATE FOR INJECTABLE FORMAULATION) (STERILE)","address":"ORCHID TOWERS,313,VALLUVARKOTTAMHIGH ROAD,NUNGAMBAKKAM","city":"CHENNAI","supplier":"ORCHID PHARMA LIMITED","supplierCountry":"INDIA","foreign_port":"SANTOS","customer":"BLAU FARMACEUTICA SA","customerCountry":"BRAZIL","quantity":"1800.00","actualQuantity":"1800","unit":"KGS","unitRateFc":"165","totalValueFC":"294078.5","currency":"USD","unitRateINR":13728,"date":"21-Oct-2024","totalValueINR":"24710400","totalValueInUsd":"294078.5","indian_port":"Madras Sea","hs_no":"29419090","bill_no":"4975910","productDescription":"API","marketType":"","country":"BRAZIL","selfForZScoreResived":"Sterile","supplierPort":"Madras Sea","supplierAddress":"ORCHID TOWERS,313,VALLUVARKOTTAMHIGH ROAD,NUNGAMBAKKAM, CHENNAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731609000,"product":"CEPHALOTHIN SODIUM BUFFERED STERILE USP(CEPHALOTHIN SODIUM WITH SODIUM BICARBONATE FOR INJECTABLE FORMULATION STERILE)","address":"ORCHID TOWERS, 313, VALLUVARKOTTAM","city":"CHENNAI","supplier":"ORCHID PHARMA LIMITED","supplierCountry":"INDIA","foreign_port":"BOGOTA","customer":"VITALIS S A C I,830.068.119-1,","customerCountry":"COLOMBIA","quantity":"170.00","actualQuantity":"170","unit":"KGS","unitRateFc":"171","totalValueFC":"27117.2","currency":"USD","unitRateINR":13461.019294117646,"date":"15-Nov-2024","totalValueINR":"2288373.28","totalValueInUsd":"27117.2","indian_port":"Madras Air","hs_no":"29419090","bill_no":"5625023","productDescription":"API","marketType":"","country":"COLOMBIA","selfForZScoreResived":"Sterile","supplierPort":"Madras Air","supplierAddress":"ORCHID TOWERS, 313, VALLUVARKOTTAM, CHENNAI","customerAddress":""},{"dataSource":"API Import","activeIngredients":"SODIUM 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BICARBONATE","year":"2021","qtr":"Q2","strtotime":1620930600,"product":"SODIUM BICARBONATE USP#4 3103973","address":"OLD NO.1\/63, NEW NO.1\/5B PUDUPAKKAMVILLAGE, VIA VANDALLUR","city":"KELAMBAKKAM ROAD, KELAMBAKKAM","supplier":"UNIVAR SOLUTIONS","supplierCountry":"SINGAPORE","foreign_port":"HOUSTON TX","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"22.68","actualQuantity":"22.68","unit":"KGS","unitRateFc":"123.5","totalValueFC":"2858.4","currency":"USD","unitRateINR":"9231.6","date":"14-May-2021","totalValueINR":"209373.26","totalValueInUsd":"2858.4","indian_port":"MADRAS AIR","hs_no":"29349990","bill_no":"3945571","productDescription":"API","marketType":"","country":"SINGAPORE","selfForZScoreResived":"Pharma Grade","supplierPort":"HOUSTON TX","supplierAddress":"","customerAddress":"OLD NO.1\/63, NEW NO.1\/5B PUDUPAKKAMVILLAGE, VIA VANDALLUR"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q2","strtotime":1624041000,"product":"(RAW 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GRADE P)","address":"MEDREICH HOUSE, NO12\/8,","city":"SEVA NAGAR, BANGALORE, KARNATAKA","supplier":"MEIJI SEIKA PHARMA","supplierCountry":"JAPAN","foreign_port":"N\/A","customer":"MEDREICH","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"9.9","totalValueFC":"251.3","currency":"USD","unitRateINR":"834.5","date":"09-Sep-2023","totalValueINR":"20861.57","totalValueInUsd":"251.3","indian_port":"Bangalore Air","hs_no":"29349990","bill_no":"7752642","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"N\/A","customerAddress":"MEDREICH HOUSE, NO12\/8,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1700591400,"product":"(RAW MATERIAL FOR PHARMACEUTICAL PRODUCTS) SODIUM BICARBONATE (JP GRADE P)","address":"MEDREICH HOUSE, NO12\/8,","city":"SEVA NAGAR, BANGALORE, KARNATAKA","supplier":"MEIJI SEIKA PHARMA","supplierCountry":"JAPAN","foreign_port":"TOKYO - NARITA","customer":"MEDREICH","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"9.9","totalValueFC":"251","currency":"USD","unitRateINR":"836","date":"22-Nov-2023","totalValueINR":"20898.85","totalValueInUsd":"251","indian_port":"Bangalore Air","hs_no":"29349990","bill_no":"8881853","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TOKYO - NARITA","supplierAddress":"4-16, KYOBASHI, 2-CHOME, CHUO-KUTOKYO-104-8002SDNF JAPAN","customerAddress":"MEDREICH HOUSE, NO12\/8,"}]
    22-Apr-2021
    15-Nov-2024
    KGS
    overview
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

    Total Value (USD)

    Quantity (KGS) & Unit rate (USD/KGS) over time

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    API Imports and Exports

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    (KGS)    		 Average Price
    (USD/KGS)    		 Number of Transactions

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - SOLUTION;IRRIGATION - 0.154MG/ML;0.9...DOSAGE - SOLUTION;IRRIGATION - 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML

    USFDA APPLICATION NUMBER - 18469

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    DOSAGE - FOR SOLUTION;ORAL - 420GM/BOT;1.48GM...DOSAGE - FOR SOLUTION;ORAL - 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT

    USFDA APPLICATION NUMBER - 19797

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    DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML)

    USFDA APPLICATION NUMBER - 207026

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    DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;3....DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML)

    USFDA APPLICATION NUMBER - 207026

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    DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)

    USFDA APPLICATION NUMBER - 21703

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    DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

    USFDA APPLICATION NUMBER - 21703

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    DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

    USFDA APPLICATION NUMBER - 21703

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    DOSAGE - INJECTABLE;INJECTION - 5.15GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

    USFDA APPLICATION NUMBER - 21703

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    DOSAGE - INJECTABLE;INJECTION - 5.15GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

    USFDA APPLICATION NUMBER - 21703

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    DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20...DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

    USFDA APPLICATION NUMBER - 21703

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    DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20...DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.44GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

    USFDA APPLICATION NUMBER - 21703

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    DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20...DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)

    USFDA APPLICATION NUMBER - 21703

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    DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20...DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)

    USFDA APPLICATION NUMBER - 21703

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    DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;N/...DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

    USFDA APPLICATION NUMBER - 21703

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    DOSAGE - CAPSULE;ORAL - 20MG;1.1GM

    USFDA APPLICATION NUMBER - 21849

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    DOSAGE - CAPSULE;ORAL - 40MG;1.1GM

    USFDA APPLICATION NUMBER - 21849

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    DOSAGE - CAPSULE;ORAL - 20MG;1.1GM

    USFDA APPLICATION NUMBER - 22281

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    Ph. Eur. Grade Sodium Bicarbonate Excipient needed in India [ENA22071]
    A company that focuses on development of various generic drugs is looking for suppliers of Ph. Eur. Grade Sodium Bicarbonate Excipient. The initial required quantity is 5 kg - 10 kg for development and 200 kg to exhibit batches. The suppliers must support this enquiry with CoA.
    13 Feb 2025

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    13 Feb 2025

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    13 Feb 2025

    Germany.png
    Various Excipients needed in Germany [ENA19027]
    A CMO that focuses on manufacturing and packaging of soft gum is looking for suppliers of various excipients for development purposes. The supplier must support this enquiry with EU Food Law, USFDA & CoA. 1. MCC (5 kg) Excipient 2. Sodium Carbonate (0.5 kg) Excipient 3. Sodium Bicarbonate (1 kg) Excipient 4. Xylitol (0.5 kg) Excipient 5. Erythritol (0.5 kg) Excipient
    10 Feb 2024

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    10 Feb 2024

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    10 Feb 2024

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    Various Excipients needed in India [ENA18745]
    A company that focuses on manufacturing of tablets, capsules & oral liquids is looking for suppliers of Various Excipient for commercial purposes. The supplier must support this enquiry with CoA. 1. USP Grade Mannitol (100 kg) Excipient 2. USP Grade Maltodextrin (15 kg) Excipient 3. USP Grade Sodium bicarbonate (50 kg) Excipient 4. USP Grade Tartaric acid (5 kg) Excipient
    09 Dec 2023

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    09 Dec 2023

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    09 Dec 2023

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    ABOUT THIS PAGE

    Looking for 144-55-8 / Sodium Bicarbonate API manufacturers, exporters & distributors?

    Sodium Bicarbonate manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Sodium Bicarbonate

    Synonyms

    Sodium hydrogen carbonate, 144-55-8, Baking soda, Sodium hydrogencarbonate, Sodium acid carbonate, Carbonic acid monosodium salt

    Cas Number

    144-55-8

    Unique Ingredient Identifier (UNII)

    8MDF5V39QO

    About Sodium Bicarbonate

    A white, crystalline powder that is commonly used as a pH buffering agent, an electrolyte replenisher, systemic alkalizer and in topical cleansing solutions.

    PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 Manufacturers

    A PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5, including repackagers and relabelers. The FDA regulates PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PRISMASOL BGK 4/2.5 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 PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 Suppliers

    A PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 supplier is an individual or a company that provides PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 active pharmaceutical ingredient (API) or PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 finished formulations upon request. The PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 suppliers may include PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 API manufacturers, exporters, distributors and traders.

    click here to find a list of PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 USDMF

    A PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 DMF (Drug Master File) is a document detailing the whole manufacturing process of PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 active pharmaceutical ingredient (API) in detail. Different forms of PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 DMFs exist exist since differing nations have different regulations, such as PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 DMF submitted to regulatory agencies in the US is known as a USDMF. PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 USDMF includes data on PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 suppliers with USDMF on PharmaCompass.

    PRISMASOL BGK 4/2.5 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 PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 Drug Master File in Japan (PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 JDMF) empowers PRISMASOL BGK 4/2.5 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 PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 JDMF during the approval evaluation for pharmaceutical products. At the time of PRISMASOL BGK 4/2.5 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 PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 suppliers with JDMF on PharmaCompass.

    PRISMASOL BGK 4/2.5 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 PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 Drug Master File in Korea (PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5. The MFDS reviews the PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 KDMF as part of the drug registration process and uses the information provided in the PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 KDMF to evaluate the safety and efficacy of the drug.

    After submitting a PRISMASOL BGK 4/2.5 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 PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 suppliers with KDMF on PharmaCompass.

    PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 CEP

    A PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 CEP of the European Pharmacopoeia monograph is often referred to as a PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 Certificate of Suitability (COS). The purpose of a PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 to their clients by showing that a PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 CEP has been issued for it. The manufacturer submits a PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 CEP (COS) as part of the market authorization procedure, and it takes on the role of a PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 CEP holder for the record. Additionally, the data presented in the PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 DMF.

    A PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 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 PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 suppliers with CEP (COS) on PharmaCompass.

    PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 WC

    A PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 written confirmation (PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 WC) is an official document issued by a regulatory agency to a PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 manufacturer, verifying that the manufacturing facility of a PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 APIs or PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 finished pharmaceutical products to another nation, regulatory agencies frequently require a PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 WC (written confirmation) as part of the regulatory process.

    click here to find a list of PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 suppliers with Written Confirmation (WC) on PharmaCompass.

    PRISMASOL BGK 4/2.5 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 PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for PRISMASOL BGK 4/2.5 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 PRISMASOL BGK 4/2.5 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 PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a PRISMASOL BGK 4/2.5 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 PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 suppliers with NDC on PharmaCompass.

    PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 GMP

    PRISMASOL BGK 4/2.5 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 PRISMASOL BGK 4/2.5 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 PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 GMP manufacturer or PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 GMP API supplier for your needs.

    PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 CoA

    A PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 CoA (Certificate of Analysis) is a formal document that attests to PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5's compliance with PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 specifications and serves as a tool for batch-level quality control.

    PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 CoA mostly includes findings from lab analyses of a specific batch. For each PRISMASOL BGK 4/2.5 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.

    PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 may be tested according to a variety of international standards, such as European Pharmacopoeia (PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 EP), PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER-5 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (PRISMASOL BGK 4/2.5 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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