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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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    DMF Number : 32237

    Submission : 2017-12-13

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    Certificate Number : CEP 2022-467 - Rev 01

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    Substance Number : 195

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    Registration Number : 20200113-211-J-530

    Manufacturer Name : Emnar Pharma Private Limited

    Manufacturer Address : Unit-II Plot No. 15 Jawaharlal Nehru Pharma City, Tadi (Village), Parawada (Mandal), Anakapalli (District), India.

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    DMF Number : 32436

    Submission : 2018-01-19

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    Registration Number : 20200113-211-J-530

    Manufacturer Name : Emnar Pharma Private Limited

    Manufacturer Address : Unit-II Plot No. 15 Jawaharlal Nehru Pharma City, Tadi (Village), Parawada (Mandal), Anakapalli (District), India.

     VMF Others AUDIT
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    05

    Global Calcium

    India

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

    Duphat
    Not Confirmed
    arrow

    Global Calcium

    India

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

    arrow
    Duphat
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38670

    Submission : 2023-09-26

    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

    Duphat
    Not Confirmed
    arrow

    SAFC

    U.S.A

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

    arrow
    Duphat
    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

    Duphat
    Not Confirmed
    arrow

    SAFC

    U.S.A

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

    arrow
    Duphat
    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

    Duphat
    Not Confirmed
    arrow

    SAFC

    U.S.A

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

    arrow
    Duphat
    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

    Duphat
    Not Confirmed
    arrow

    SAFC

    U.S.A

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

    arrow
    Duphat
    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

    Duphat
    Not Confirmed
    arrow

    SAFC

    U.S.A

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

    arrow
    Duphat
    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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    USDMF

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    01

    Acs Dobfar Spa

    Italy

    USDMF

    arrow
    Pharmatech Expo 2025
    Not Confirmed

    01

    Acs Dobfar Spa

    Italy
    arrow
    Pharmatech Expo 2025
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12585

    Submission : 1997-07-09

    Status : Active

    Type : II

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    02

    Pharmatech Expo 2025
    Not Confirmed

    02

    Pfizer Healthcare India Pvt Ltd

    U.S.A
    arrow
    Pharmatech Expo 2025
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21689

    Submission : 2008-07-23

    Status : Inactive

    Type : II

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    03

    Pharmatech Expo 2025
    Not Confirmed

    03

    Luitpold Pharmaceuticals Inc

    U.S.A
    arrow
    Pharmatech Expo 2025
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15236

    Submission : 2000-12-28

    Status : Inactive

    Type : II

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    04

    Pharmatech Expo 2025
    Not Confirmed

    04

    Sun Pharmaceutical Industries Ltd

    India
    arrow
    Pharmatech Expo 2025
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20090

    Submission : 2006-12-27

    Status : Inactive

    Type : II

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    05

    Safc Biosciences Inc

    U.S.A

    USDMF

    arrow
    Pharmatech Expo 2025
    Not Confirmed

    05

    Safc Biosciences Inc

    U.S.A
    arrow
    Pharmatech Expo 2025
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16457

    Submission : 2003-02-28

    Status : Inactive

    Type : II

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    06

    Safc Biosciences Inc

    U.S.A

    USDMF

    arrow
    Pharmatech Expo 2025
    Not Confirmed

    06

    Safc Biosciences Inc

    U.S.A
    arrow
    Pharmatech Expo 2025
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21368

    Submission : 2008-02-01

    Status : Inactive

    Type : II

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    07

    Safc Biosciences Inc

    U.S.A

    USDMF

    arrow
    Pharmatech Expo 2025
    Not Confirmed

    07

    Safc Biosciences Inc

    U.S.A
    arrow
    Pharmatech Expo 2025
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19772

    Submission : 2006-09-01

    Status : Inactive

    Type : II

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    08

    Safc Biosciences Inc

    U.S.A

    USDMF

    arrow
    Pharmatech Expo 2025
    Not Confirmed

    08

    Safc Biosciences Inc

    U.S.A
    arrow
    Pharmatech Expo 2025
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19557

    Submission : 2006-05-29

    Status : Inactive

    Type : II

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    09

    Safc Biosciences Inc

    U.S.A

    USDMF

    arrow
    Pharmatech Expo 2025
    Not Confirmed

    09

    Safc Biosciences Inc

    U.S.A
    arrow
    Pharmatech Expo 2025
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21545

    Submission : 2008-03-31

    Status : Inactive

    Type : II

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    10

    Pharmatech Expo 2025
    Not Confirmed

    10

    Savior Lifetec Corp Tainan Branch

    Taiwan
    arrow
    Pharmatech Expo 2025
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 25850

    Submission : 2012-03-05

    Status : Inactive

    Type : II

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    CEP/COS

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    EMNAR PHARMA PRIVATE LIMITED Hydera...

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      • EDQM
      • WHO-GMP
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      Sodium hydrogen carbonate

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      CEP 2022-467 - Rev 01
      Valid
      Chemical
      2023-10-27
      195
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      01

      EMNAR PHARMA PRIVATE LIMITED Hydera...

      India
      Pharma, Lab & Chemical Expo
      Not Confirmed
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      NOVABAY Pte. Ltd Singapore SG

      Contact Supplier
        • fda
        • EDQM
        • WHO-GMP
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        Flag France
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        Sodium hydrogen carbonate

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        CEP 2022-300 - Rev 00
        Valid
        Chemical
        2024-02-22
        195
        blank

        02

        NOVABAY Pte. Ltd Singapore SG

        France
        Pharma, Lab & Chemical Expo
        Not Confirmed
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        NOVABAY Pte. Ltd Singapore SG

        France
        arrow
        Pharma, Lab & Chemical Expo
        Not Confirmed
        • fda
        • EDQM
        • WHO-GMP
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        Sodium hydrogen carbonate

        Certificate Number : CEP 2022-300 - Rev 00

        Status : Valid

        Issue Date : 2024-02-22

        Type : Chemical

        Substance Number : 195

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        Solvay Quimica, S.L. Martorell ES

        Contact Supplier
        • FDA
        • fda
        • EDQM
        • WHO-GMP
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        Flag Belgium
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        Sodium hydrogen carbonate

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        R1-CEP 2006-043 - Rev 00
        Valid
        Chemical
        2012-03-13
        195
        blank

        03

        Solvay Quimica, S.L. Martorell ES

        Belgium
        Pharma, Lab & Chemical Expo
        Not Confirmed
        arrow

        Solvay Quimica, S.L. Martorell ES

        Belgium
        arrow
        Pharma, Lab & Chemical Expo
        Not Confirmed
        • fda
        • EDQM
        • WHO-GMP
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        Sodium hydrogen carbonate

        Certificate Number : R1-CEP 2006-043 - Rev 00

        Status : Valid

        Issue Date : 2012-03-13

        Type : Chemical

        Substance Number : 195

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        SOLVAY PEROXYTHAI LIMITED Rayong TH

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        • fda
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        R0-CEP 2020-228 - Rev 00
        Valid
        Chemical
        2022-04-08
        195
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        04

        SOLVAY PEROXYTHAI LIMITED Rayong TH

        Italy
        Pharma, Lab & Chemical Expo
        Not Confirmed
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        SOLVAY PEROXYTHAI LIMITED Rayong TH

        Italy
        arrow
        Pharma, Lab & Chemical Expo
        Not Confirmed
        • fda
        • EDQM
        • WHO-GMP
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        Certificate Number : R0-CEP 2020-228 - Rev 00

        Status : Valid

        Issue Date : 2022-04-08

        Type : Chemical

        Substance Number : 195

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        SOLVAY OPERATIONS FRANCE Paris FR

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        R1-CEP 2004-252 - Rev 01
        Valid
        Chemical
        2017-01-24
        195
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        05

        SOLVAY OPERATIONS FRANCE Paris FR

        Italy
        Pharma, Lab & Chemical Expo
        Not Confirmed
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        SOLVAY OPERATIONS FRANCE Paris FR

        Italy
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        Pharma, Lab & Chemical Expo
        Not Confirmed
        • fda
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        Sodium hydrogen carbonate

        Certificate Number : R1-CEP 2004-252 - Rev 01

        Status : Valid

        Issue Date : 2017-01-24

        Type : Chemical

        Substance Number : 195

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        API Reference Price

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        [{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1688581800,"product":"SODIUM BICARBONATE","address":"OFFICE110 A EVOMA 88,BOREWELL ROAD","city":"WHITEFIELD BANGALORE,KARNATAKA","supplier":"BUGWORKS","supplierCountry":"INDIA","foreign_port":"ADELAIDE","customer":"CHAI YEE","customerCountry":"AUSTRALIA","quantity":"2.50","actualQuantity":"2.5","unit":"KGS","unitRateFc":"300","totalValueFC":"474.5","currency":"USD","unitRateINR":15599.984400000001,"date":"06-Jul-2023","totalValueINR":"38999.961","totalValueInUsd":"474.5","indian_port":"BANGALORE AIR","hs_no":"29339990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"AUSTRALIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BANGALORE AIR","supplierAddress":"OFFICE110 A EVOMA 88,BOREWELL ROAD, WHITEFIELD BANGALORE,KARNATAKA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1695580200,"product":"CEPHALOTIN SODIUM BUFFERED STERILE (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":"SANTOS","customer":"BLAU FARMACEUTICA S,A..,","customerCountry":"BRAZIL","quantity":"1355.00","actualQuantity":"1355","unit":"KGS","unitRateFc":"170","totalValueFC":"228387","currency":"USD","unitRateINR":13991.143911439114,"date":"25-Sep-2023","totalValueINR":"18958000","totalValueInUsd":"228387","indian_port":"Ennore","hs_no":"29419090","bill_no":"4152857","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Sterile","supplierPort":"Ennore","supplierAddress":"ORCHID TOWERS,313,VALLUVARKOTTAMHIGH ROAD,NUNGAMBAKKAM, CHENNAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1695753000,"product":"CEPHALOTHIN SODIUM (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":"VICAR FARMACEUTICA S.A","customerCountry":"COLOMBIA","quantity":"370.00","actualQuantity":"370","unit":"KGS","unitRateFc":"172","totalValueFC":"63078.1","currency":"USD","unitRateINR":14151.351351351352,"date":"27-Sep-2023","totalValueINR":"5236000","totalValueInUsd":"63078.1","indian_port":"Madras Air","hs_no":"29419090","bill_no":"4217357","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"COLOMBIA","selfForZScoreResived":"Sterile","supplierPort":"Madras Air","supplierAddress":"ORCHID TOWERS,313,VALLUVARKOTTAMHIGH ROAD,NUNGAMBAKKAM, CHENNAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706034600,"product":"CEPHALOTHIN SODIUM USP 44 (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":"HO CHI MINH C","customer":"MEKOPHAR CHEMICAL PHARMACEUTICAL ","customerCountry":"VIETNAM","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"175","totalValueFC":"3413.5","currency":"USD","unitRateINR":14184.953,"date":"24-Jan-2024","totalValueINR":"283699.06","totalValueInUsd":"3413.5","indian_port":"Madras Air","hs_no":"29419090","bill_no":"6980058","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"VIETNAM, DEMOCRATIC REP. OF","selfForZScoreResived":"Sterile","supplierPort":"Madras Air","supplierAddress":"ORCHID TOWERS,313,VALLUVARKOTTAMHIGH ROAD,NUNGAMBAKKAM, CHENNAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1707071400,"product":"CEPHALOTHIN SODIUM STERILE (BUFFERED) USP (CEPHALOTHIN SODIUM WITH SODIUM BICARBONATE FOR INJECTABLE FORMULATION (TERILE","address":"ORCHID TOWERS,313,VALLUVARKOTTAMHIGH ROAD,NUNGAMBAKKAM","city":"CHENNAI","supplier":"ORCHID PHARMA LIMITED","supplierCountry":"INDIA","foreign_port":"BUENOS AIRES","customer":"INSTITUTO BIOLOGICO CONTEMPORANEO ","customerCountry":"ARGENTINA","quantity":"120.00","actualQuantity":"120","unit":"KGS","unitRateFc":"176","totalValueFC":"19929.1","currency":"USD","unitRateINR":13779.922916666666,"date":"05-Feb-2024","totalValueINR":"1653590.75","totalValueInUsd":"19929.1","indian_port":"Madras Air","hs_no":"29419090","bill_no":"7290257","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Sterile","supplierPort":"Madras Air","supplierAddress":"ORCHID TOWERS,313,VALLUVARKOTTAMHIGH ROAD,NUNGAMBAKKAM, CHENNAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1708453800,"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 ","customerCountry":"COLOMBIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"173","totalValueFC":"16213.4","currency":"USD","unitRateINR":13452.91,"date":"21-Feb-2024","totalValueINR":"1345291","totalValueInUsd":"16213.4","indian_port":"Madras Air","hs_no":"29419090","bill_no":"7704483","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"COLOMBIA","selfForZScoreResived":"Sterile","supplierPort":"Madras Air","supplierAddress":"ORCHID TOWERS,313,VALLUVARKOTTAMHIGH ROAD,NUNGAMBAKKAM, CHENNAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717353000,"product":"CEPHALOTIN SODIUM BUFFERED STERILE (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":"SANTOS","customer":"BLAU FARMACEUTICA S.A","customerCountry":"BRAZIL","quantity":"1780.00","actualQuantity":"1780","unit":"KGS","unitRateFc":"165","totalValueFC":"290781.9","currency":"USD","unitRateINR":13637.25,"date":"03-Jun-2024","totalValueINR":"24274305","totalValueInUsd":"290781.9","indian_port":"Kattupalli","hs_no":"29419090","bill_no":"1391006","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Sterile","supplierPort":"Kattupalli","supplierAddress":"ORCHID TOWERS,313,VALLUVARKOTTAMHIGH ROAD,NUNGAMBAKKAM, CHENNAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724351400,"product":"CEPHALOTHIN SODIUM STERILE (CEPHALOTHINSODIUM WITH SODIUM BICARBONATE FORINJECTABLE FORMULATION (STERILE)","address":"ORCHID TOWERS,313,VALLUVARKOTTAMHIGH ROAD,NUNGAMBAKKAM","city":"CHENNAI","supplier":"ORCHID PHARMA LIMITED","supplierCountry":"INDIA","foreign_port":"BUENOS AIRES, BA","customer":"KILAB SRL,","customerCountry":"ARGENTINA","quantity":"60.00","actualQuantity":"60","unit":"KGS","unitRateFc":"178","totalValueFC":"9542.5","currency":"USD","unitRateINR":13340.218666666666,"date":"23-Aug-2024","totalValueINR":"800413.12","totalValueInUsd":"9542.5","indian_port":"Madras Air","hs_no":"29419090","bill_no":"3417224","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Sterile","supplierPort":"Madras Air","supplierAddress":"ORCHID TOWERS,313,VALLUVARKOTTAMHIGH ROAD,NUNGAMBAKKAM, CHENNAI","customerAddress":""},{"dataSource":"API Import","activeIngredients":"SODIUM BICARBONATE","year":"2021","qtr":"Q1","strtotime":1613500200,"product":"(RAW MATERIAL FOR PHARMACEUTICAL PRODUCTS) SODIUM BICARBONATE (JP GRADE P)","address":"MEDREICH HOUSE, NO12\/8,SARASWATHI AMMAL STREET, MARUTHI","city":"SEVA NAGAR, BANGALORE, KARNATAKA","supplier":"MEIJI SEIKA PHARMA","supplierCountry":"JAPAN","foreign_port":"TOKYO - NARITA","customer":"MEDREICH","customerCountry":"INDIA","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"7.5","totalValueFC":"571.7","currency":"USD","unitRateINR":"555","date":"17-Feb-2021","totalValueINR":"41623.2","totalValueInUsd":"571.7","indian_port":"BANGALORE AIR","hs_no":"29339990","bill_no":"2797690","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TOKYO - NARITA","supplierAddress":"","customerAddress":"MEDREICH HOUSE, NO12\/8,SARASWATHI AMMAL STREET, MARUTHI"}]
        17-Feb-2021
        23-Aug-2024
        KGS
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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

        API Imports and Exports

        Importing Country Total Quantity
        (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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        USP

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        ABOUT THIS PAGE

        Sodium Bicarbonate Manufacturers

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

        Sodium Bicarbonate Suppliers

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

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

        Sodium Bicarbonate USDMF

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

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

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

        Sodium Bicarbonate 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 Sodium Bicarbonate Drug Master File in Japan (Sodium Bicarbonate JDMF) empowers Sodium Bicarbonate 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 Sodium Bicarbonate JDMF during the approval evaluation for pharmaceutical products. At the time of Sodium Bicarbonate 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 Sodium Bicarbonate suppliers with JDMF on PharmaCompass.

        Sodium Bicarbonate KDMF

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

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

        After submitting a Sodium Bicarbonate 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 Sodium Bicarbonate API can apply through the Korea Drug Master File (KDMF).

        click here to find a list of Sodium Bicarbonate suppliers with KDMF on PharmaCompass.

        Sodium Bicarbonate CEP

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

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

        Sodium Bicarbonate WC

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

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

        Sodium Bicarbonate 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 Sodium Bicarbonate as an active pharmaceutical ingredient (API).

        Finished drug products

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

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

        Sodium Bicarbonate GMP

        Sodium Bicarbonate 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 Sodium Bicarbonate 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 Sodium Bicarbonate GMP manufacturer or Sodium Bicarbonate GMP API supplier for your needs.

        Sodium Bicarbonate CoA

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

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

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