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    Chemistry

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    Also known as: 14882-18-9, Bismuth oxysalicylate, Bismuth oxide salicylate, Wismutsubsalicylat, Basic bismuth salicylate, Bismuthi subsalicylas
    Molecular Formula
    C7H6BiO4
    Molecular Weight
    363.10  g/mol
    InChI Key
    QBWLKDFBINPHFT-UHFFFAOYSA-L
    Bismuth Subsalicylate
    Bismuth Subsalicylate is a bismuth salt of salicylic acid. Little absorbed from the gastrointestinal tract, bismuth subsalicylate exerts a local effect on the gastric mucosa, coating it and protecting it from the corrosive effects of acid and pepsin. This agent also has local antimicrobial properties. (NCI04)
    1 2D Structure

    Bismuth Subsalicylate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 InChI
    InChI=1S/C7H6O3.Bi.H2O/c8-6-4-2-1-3-5(6)7(9)10;;/h1-4,8H,(H,9,10);;1H2/q;+2;/p-2
    2.1.2 InChI Key
    QBWLKDFBINPHFT-UHFFFAOYSA-L
    2.1.3 Canonical SMILES
    C1=CC=C2C(=C1)C(=O)O[Bi]O2.O
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Helidac

    2. Kaopectate

    3. Pepto-bismol

    4. Subsalicylate Bismuth

    5. Trigastronol

    2.2.2 Depositor-Supplied Synonyms

    1. 14882-18-9

    2. Bismuth Oxysalicylate

    3. Bismuth Oxide Salicylate

    4. Wismutsubsalicylat

    5. Basic Bismuth Salicylate

    6. Bismuthi Subsalicylas

    7. 4h-1,3,2-benzodioxabismin-4-one, 2-hydroxy-

    8. Bismutum Subsalicylicum

    9. Bismuth(iii) Subsalicylate

    10. Pink Bismuth

    11. Bismuth, (2-hydroxybenzoato-o1,o2)oxo-

    12. Stabisol

    13. Vismut

    14. Spiromak Forte

    15. Ncgc00166299-01

    16. Trigastronol

    17. 2-hydroxy-benzo[1,3,2]dioxabismin-4-one

    18. Bismuth Oxysalicylate;bismuth(iii) Salicylate Basic

    19. 2-hydroxy-2h,4h-benzo[d]1,3-dioxa-2-bismacyclohexan-4-one

    20. Bismuth Salicylate, Basic

    21. Wismutsalicylat, Basisches

    22. Bismuth, Oxo(salicylato)-

    23. Bismogenol Tosse Inj

    24. Ccris 4751

    25. Hsdb 332

    26. Salicylic Acid Basic Bismuth Salt

    27. Salicylic Acid, Bismuth Basic Salt

    28. Einecs 238-953-1

    29. Unii-62tey51rr1

    30. Bismuth, (2-hydroxybenzoato-o(1),o(2))oxo-

    31. Wismutoxidsalicylat

    32. 2-hydroxybenzoic Acid Bismuth (3+) Salt, Basic

    33. Bismuth-subsalicylate

    34. Mfcd00085368

    35. Pepto-bismol (tn)

    36. Bismuth Subsalicylate [usan:usp:jan]

    37. Dsstox_cid_4622

    38. 2-hydroxy-4h-1,3,2-benzodioxabismin-4-one

    39. Ec 238-953-1

    40. Dsstox_rid_77471

    41. Dsstox_gsid_24622

    42. Mls000069654

    43. Dtxsid6024622

    44. Bismuth Subsalicylate (jan/usp)

    45. Chebi:261649

    46. Hms2093h13

    47. Pharmakon1600-01505412

    48. Hy-b0550

    49. Tox21_112398

    50. Nsc759117

    51. Akos015888405

    52. Ccg-213424

    53. Db01294

    54. Nsc 759117

    55. Ncgc00166299-03

    56. 2-hydroxy-1,3,2-benzodioxabismin-4-one

    57. As-65783

    58. Smr000059234

    59. Sbi-0206855.p001

    60. Cas-14882-18-9

    61. C07870

    62. D00728

    63. Ab00489978_02

    64. 2-hydroxy-4h-benzo[d][1,3,2]dioxabismin-4-one

    65. Sr-05000001933

    66. J-008518

    67. Sr-05000001933-1

    68. Bismuth(iii) Subsalicylate, 99.9% Trace Metals Basis

    69. Bismuth(iii) Salicylate Basic, Purum, >=97.0% (kt)

    70. Bismuth Oxysalicylate, Bismuth Subsalicylate, Bismuth(iii) Salicylate Basic

    71. Bismuth Subsalicylate, United States Pharmacopeia (usp) Reference Standard

    72. 87-27-4

    2.3 Create Date
    2007-08-23
    3 Chemical and Physical Properties
    Molecular Weight 363.10 g/mol
    Molecular Formula C7H6BiO4
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count0
    Exact Mass363.00701 g/mol
    Monoisotopic Mass363.00701 g/mol
    Topological Polar Surface Area36.5 Ų
    Heavy Atom Count12
    Formal Charge0
    Complexity173
    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 Therapeutic Uses

    USED MEDICINALLY AS INTESTINAL ABSORBENT.

    Gosselin, R.E., H.C. Hodge, R.P. Smith, and M.N. Gleason. Clinical Toxicology of Commercial Products. 4th ed. Baltimore: Williams and Wilkins, 1976., p. II-93

    MEDICATION (VET): ANTIDIARRHEAL. WEAK INTESTINAL ANTISEPTIC DUE TO LIBERATION OF SALICYLIC ACID. USUALLY COMBINED WITH CARBONATES TO MINIMIZE IRRITANT EFFECTS OF FREE ACID WHILE UTILIZING PROTECTIVE EFFECT OF BISMUTH.

    Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 48

    THE CMPD IS SOMETIMES USED ORALLY TO ALLAY DIARRHEA OR TO SOOTHE GASTRITIS OR PEPTIC ULCER. ... BEFORE THE ADVENT OF PENICILLIN, BISMUTH SUBSALICYLATE WAS MUCH USED IN THE TREATMENT OF SYPHILIS...

    Hayes, W.J., Jr., E.R. Laws, Jr., (eds.). Handbook of Pesticide Toxicology. Volume 2. Classes of Pesticides. New York, NY: Academic Press, Inc., 1991., p. 542

    /SRP: FORMER/ TREATMENT OF VINCENT'S ANGINA, SYPHILIS

    American Hospital Formulary Service. Volumes I and II. Washington, DC: American Society of Hospital Pharmacists, to 1984., p. 8:28

    For more Therapeutic Uses (Complete) data for BISMUTH SUBSALICYLATE (7 total), please visit the HSDB record page.

    4.2 Drug Warning

    EVEN WHEN ITS USE WAS EXTENSIVE, THE GRADUAL IM INJECTION USED AGAINST SYPHILIS RARELY LED TO SERIOUS POISONING. IT WAS CUSTOMARY TO STOP TREATMENT IF GINGIVITIS, ALBUMINURIA, CUTANEOUS ERUPTIONS, OR MARKED DIARRHEA APPEARED.

    Hayes, W.J., Jr., E.R. Laws, Jr., (eds.). Handbook of Pesticide Toxicology. Volume 2. Classes of Pesticides. New York, NY: Academic Press, Inc., 1991., p. 543

    BIOAVAILABILITY OF DOXYCYCLINE WAS SIGNIFICANTLY REDUCED BY 37% & 51%, RESPECTIVELY, WHEN SUBSALICYLATE BISMUTH WAS GIVEN SIMULTANEOUSLY & AS A MULTIPLE-DOSE REGIMEN BEFORE DOXYCYCLINE. SUBSALICYLATE BISMUTH SHOULD NOT BE TAKEN WHEN DOXYCYCLINE IS USED FOR THERAPEUTIC PURPOSES. AUTHORS SUGGEST TRAVELERS SHOULD NOT TAKE THE AGENTS TOGETHER IN AN EFFORT TO PREVENT DIARRHEA.

    PMID:7040708 ERICSSON CD ET AL; JAMA 247 (16): 2266 (1982)

    The excretion of large amounts of bismuth obtained from bismuth subsalicylate into breast milk is not expected because of the poor absorption of bismuth into the systemic circulation. Salicylates, however, are excreted in milk and are eliminated more slowly from milk than from plasma with milk:plasma ratios, rising from 0.03-0.08 at 3 hours to 0.34 at 12 hours. Due to the potential for adverse effects in the nursing infant, the American Academy of Pediatrics recommends that salicylates should be used cautiously during breast feeding. A recent review also states that bismuth subsalicylate should be avoided during lactation because of systemic salicylate absorption.

    Briggs, G.G, R.K. Freeman, S.J. Yaffe. A Reference Guide to Fetal and Neonatal Risk. Drugs in Pregnancy and Lactation. 4th ed. Baltimore, MD: Williams & Wilkins 1994., p. 96

    Although the risk for toxicity may be small, significant fetal adverse effects have resulted from chronic exposure to salicylates Because of this, the use of bismuth subsalicyate during gestation should be restricted to the first half of pregnancy and then only in amounts that do not exceed the recommended doses.

    Briggs, G.G, R.K. Freeman, S.J. Yaffe. A Reference Guide to Fetal and Neonatal Risk. Drugs in Pregnancy and Lactation. 4th ed. Baltimore, MD: Williams & Wilkins 1994., p. 96

    4.3 Minimum/Potential Fatal Human Dose

    3(?). 3= MODERATELY TOXIC: PROBABLE ORAL LETHAL DOSE (HUMAN) 0.5-5 G/KG, BETWEEN 1 OZ & 1 PINT FOR 70 KG PERSON (150 LB).

    Gosselin, R.E., H.C. Hodge, R.P. Smith, and M.N. Gleason. Clinical Toxicology of Commercial Products. 4th ed. Baltimore: Williams and Wilkins, 1976., p. II-93

    4.4 Drug Indication

    Bismuth subsalicylate is indicated to temporarily relieve diarrhea, travelers' diarrhea, and upset stomach due to overindulgence in food and drink, including heartburn, indigestion, nausea, gas, belching, and fullness. Bismuth subsalicylate is a component of HELIDAC Therapy (bismuth subsalicylate, [metronidazole], and [tetracycline]), which is a treatment regimen indicated for the eradication of _H. pylori_ for treatment of patients with _H. pylori_ infection and duodenal ulcer disease.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Bismuth subsalicylate is an antacid and antimicrobial, gastroprotective, anti-secretory, and anti-inflammatory actions. It works to reduce the severity and incidence of flatulence and diarrhea, and consequently relieving gastrointestinal discomfort. In one study, bismuth subsalicylate was prevented traveler's diarrhea with a protection rate >60%. Organobismuth compounds, formed by the breakdown of bismuth subsalicylate in the gastrointestinal tract, inhibit the growth of _Helicobacter pylori_ and other bacteria implicated in gastrointestinal disorders, and some fungi. In one study, bismuth subsalicylate was shown to eradicate up to 90% of _H. pylori_ infection when used as part of a quadruple therapy regimen containing a proton pump inhibitor, tetracycline, and metronidazole. Bismuth subsalicylate exhibited antimicrobial activity against _Clostridium difficile_, enterotoxigenic _Escherichia coli_ O157:H7, _norovirus_, and other common enteric pathogens such as _Salmonella_ and _Shigella_.

    5.2 MeSH Pharmacological Classification

    Antidiarrheals

    Miscellaneous agents found useful in the symptomatic treatment of diarrhea. They have no effect on the agent(s) that cause diarrhea, but merely alleviate the condition. (See all compounds classified as Antidiarrheals.)

    5.3 FDA Pharmacological Classification
    5.3.1 Pharmacological Classes
    Bismuth [EPC]; Bismuth [CS]
    5.4 Absorption, Distribution and Excretion

    Absorption

    Following oral administration, bismuth subsalicylate hydrolyzes into bismuth and salicylic acid in the stomach. Salicylic acid is almost completely absorbed in the small intestine and reaches plasma peak levels one to two hours after dosing. In one study involving healthy male subjects, oral administration of 60 mL Pepto-Bismol, a common over-the-counter product of bismuth subsalicylate, equivalent to 1050 mg of bismuth subsalicylate, resulted in the peak plasma concentration of salicylate of 40.1 g/mL, with a time to peak concentration (Tmax) of 1.8 hours. Less than 1% of bismuth from bismuth subsalicylate is absorbed from the gastrointestinal tract into the systemic circulation. In one study, oral administration of 787 mg bismuth subsalicylate in the chewable tablet form for two weeks resulted in the mean trough blood bismuth concentration was 5.1 3.1 ng/mL. In another study, the mean trough blood bismuth concentration ranged from five to 32 ng/mL following oral administration of 525 mg bismuth subsalicylate in the liquid suspension form.

    Route of Elimination

    Following oral administration, salicylate dissociated from bismuth subsalicylate is excreted in the urine. Bismuth is primarily eliminated via urinary and biliary routes.

    Volume of Distribution

    There is no information available.

    Clearance

    The renal clearance of bismuth is 50 18 mL/min.

    THE AUTOPSY DISTRIBUTION OF BISMUTH IN 22 PATIENTS WHO RECEIVED THERAPEUTIC IM INJECTIONS (MAINLY BISMUTH SALICYLATE) WAS AS FOLLOWS (MEDIAN VALUES, MG/KG, WET WEIGHT): KIDNEY 33.3; LIVER 6.8; SPLEEN 1.6; COLON 1.2; LUNG 0.9; BRAIN 0.6 & BLOOD 0.5.

    Friberg, L., Nordberg, G.F., Kessler, E. and Vouk, V.B. (eds). Handbook of the Toxicology of Metals. 2nd ed. Vols I, II.: Amsterdam: Elsevier Science Publishers B.V., 1986., p. 121

    In the gastrointestinal tract, bismuth subsalicylate is converted to salicylic acid and insoluble bismuth salts. The salicylate portion of bismuth subsalicylate is extensively absorbed (greater than 90%) and excreted in urine.

    Clayton, G.D., F.E. Clayton (eds.) Patty's Industrial Hygiene and Toxicology. Volumes 2A, 2B, 2C, 2D, 2E, 2F: Toxicology. 4th ed. New York, NY: John Wiley & Sons Inc., 1993-1994., p. 1951

    Bismuth subsalicylate (bismuth salicylate) is hydrolyzed in the gastrointestinal tract to bismuth salts and sodium salicylate. Two tablets or 30 ml suspension of the compound yields 204 mg and 258 mg, respectively, of salicylate. Inorganic bismuth salts, in contrast to organic complexes of bismuth, are relatively water-insoluble and poorly absorbed systemically, but significant absorption of salicylate does occur. A brief 1992 study found minimal absorption of bismuth (exact serum concentrations not specified) from bismuth subsalicylate in 12 healthy subjects, as opposed to a peak serum level of 0.050 ug/ml after a dose of 216 mg of colloidal bismuth subcitrate in a single patient. Some bismuth absorption was documented across the normal gastric mucosa, but the primary absorption occurred from the duodenum.

    Briggs, G.G, R.K. Freeman, S.J. Yaffe. A Reference Guide to Fetal and Neonatal Risk. Drugs in Pregnancy and Lactation. 4th ed. Baltimore, MD: Williams & Wilkins 1994., p. 95

    5.5 Metabolism/Metabolites

    Bismuth subsalicylate undergo hydrolysis at pH levels lesser than three. It is largely hydrolyzed in the stomach to bismuth oxychloride and salicylic acid. In the small intestine, unchanged bismuth subsalicylate reacts with other anions such as bicarbonate and phosphate to form insoluble bismuth salts. In the colon, unchanged bismuth subsalicylate and other bismuth salts react with hydrogen sulfide produced by anaerobic bacteria to form bismuth sulfide, a highly insoluble black salt responsible for the darkening of the stools.

    5.6 Biological Half-Life

    The terminal half-life of salicylic acid following a single oral dose of 525 mg bismuth subsalicylate is ranges from two to five hours. Bismuth has an intermediate half-life of 5 to 11 days and a terminal half-life of 21 to 72 days.

    5.7 Mechanism of Action

    The exact mechanism of bismuth subsalicylate is not fully understood. Bismuth subsalicylate is an insoluble complex that constitutes salicylic acid and trivalent bismuth. Once orally administered, bismuth subsalicylate hydrolyzes in the stomach into bismuth oxychloride, which is minimally absorbed into the bloodstream, and salicylic acid, which is almost completely absorbed. Bismuth interacts with other anions and compounds, such as hydrochloric acid, bicarbonate, phosphate, and hydrogen sulfide, in the gastrointestinal tract to form bismuth salts such as bismuth oxychloride, bismuth subcarbonate, bismuth phosphate, and bismuth sulfide. Bismuth salts possess bactericidal and antimicrobial activity, mainly by preventing bacteria from binding and growing on the mucosal cells of the stomach. It has no effects on normal gut flora. By preventing bacteria from binding to mucosal cells, bismuth subsalicylate prevents intestinal secretion and fluid loss, promotes fluid and electrolyte reabsorption, reduces gastrointestinal inflammation, and promotes the healing of pre-existing ulcer in the stomach. Salicylic acid from dissociated bismuth subsalicylate adds to the anti-inflammatory actions of bismuth salts by inhibiting the cyclooxygenase enzyme and limiting the formation of prostaglandin, a pro-inflammatory mediator. Bismuth subsalicylate exhibits cytoprotective and demulcent activity, which makes it an effective drug in peptic ulcer disease. It blocks the adhesion of H. pylori to the gastric epithelial cells and blocks the bacteria's enzyme activities, including phospholipase, protease, and urease.

    IN THE Y-1 ADRENAL CELL TISSUE CULTURE SYSTEM, A PREPN CONTAINING BISMUTH SUBSALICYLATE REDUCED THE ACTIVITY OF CRUDE TOXIN FROM VIBRIO CHOLERAE BY 104-FOLD AS COMPARED WITH THE ACTIVITY OF CONTROLS. SIMILAR RESULTS WERE OBTAINED USING THE ADULT RABBIT LIGATED INTESTINAL LOOP MODEL. THE PREPN FAILED TO AFFECT CRUDE ESCHERICHIA COLI OR CHOLERA TOXIN ACTIVITY ONCE THESE TOXINS HAD BECOME BOUND TO INTESTINAL MUCOSA.

    PMID:335003 ERICSSON CD ET AL; J INFECT DIS 136 (5): 693 (1977)

    ATTAPULGITE & PEPTO-BISMOL WERE EFFECTIVE IN REDUCING FLUID ACCUMULATION IN LIGATED SEGMENTS OF PIG INTESTINE INFECTED WITH ENTEROPATHOGENIC ESCHERICHIA COLI. FOR PEPTO-BISMOL THIS EFFECT WAS ASSOCIATED WITH AN ANTIBACTERIAL AS WELL AS AN ANTITOXIC EFFECT, PROBABLY DUE TO ITS ABSORBENT PROPERTIES. AN ASPIRIN-LIKE EFFECT IN THE GUT DUE TO THE ACTIVE INGREDIENT BISMUTH SUBSALICYLATE MAY HAVE CONTRIBUTED TO THE EFFECTIVENESS OF PEPTO-BISMOL.

    PMID:356940 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1277637 GYLES CL, ZIGLER M; CAN J COMP MED 42 (3): 260 (1978)

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LTD,MANC, MUMBAI,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728498600,"product":"BISMUTH SUBSALICYLATE","address":"B\/11, SIDDHARTH KUTIR CHS LTD,MANC","city":"MUMBAI,MAHARASHTRA","supplier":"FARMAVISION HEALTHCARE","supplierCountry":"INDIA","foreign_port":"APAPA","customer":"ECOMED PHARMA LTD.","customerCountry":"NIGERIA","quantity":"400.00","actualQuantity":"400","unit":"KGS","unitRateFc":"36","totalValueFC":"10212.4","currency":"USD","unitRateINR":2145.29115,"date":"10-Oct-2024","totalValueINR":"858116.46","totalValueInUsd":"10212.4","indian_port":"JNPT","hs_no":"29181590","bill_no":"4729412","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"NIGERIA","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"B\/11, SIDDHARTH KUTIR CHS LTD,MANC, MUMBAI,MAHARASHTRA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1674757800,"product":"BISMUTH SUBSALICYLATE MICRONIZED BATCH:222440041","address":"11TH FLR.GRANDEUR,OPP.GUNDECHA,SYM PHONY, VEERA DESAI RD.EXTENSION","city":"MUMBAI SUBURBAN,MAHARASHTRA","supplier":"OCB PHARMACEUTICAL, SRL","supplierCountry":"SPAIN","foreign_port":"NA","customer":"MARKSANS PHARMA","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"20","totalValueFC":"747.3","currency":"USD","unitRateINR":"6110.1","date":"27-Jan-2023","totalValueINR":"61100.51","totalValueInUsd":"747.3","indian_port":"BOMBAY AIR","hs_no":"29182190","bill_no":"4372739","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"NA","supplierAddress":"","customerAddress":"11TH FLR.GRANDEUR,OPP.GUNDECHA,SYM PHONY, VEERA DESAI RD.EXTENSION"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1677781800,"product":"BISMUTH SUBSALICYLATE MICRONIZED BATCH:232440012","address":"11TH FLR.GRANDEUR,OPP.GUNDECHA,SYM PHONY, VEERA DESAI RD.EXTENSION","city":"MUMBAI SUBURBAN,MAHARASHTRA","supplier":"OCB PHARMACEUTICAL, SRL","supplierCountry":"SPAIN","foreign_port":"NA","customer":"MARKSANS PHARMA","customerCountry":"INDIA","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"20","totalValueFC":"4114.3","currency":"USD","unitRateINR":"2256","date":"03-Mar-2023","totalValueINR":"338404","totalValueInUsd":"4114.3","indian_port":"BOMBAY AIR","hs_no":"29182190","bill_no":"4880804","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"NA","supplierAddress":"","customerAddress":"11TH FLR.GRANDEUR,OPP.GUNDECHA,SYM PHONY, VEERA DESAI RD.EXTENSION"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1698085800,"product":"BISMUTH SUBSALICYLATE MICRONIZED (0244) (232440086, 232440087)","address":"11TH FLOOR, LOTUS BUSINESS PARK,","city":"MUMBAI,MAHARASHTRA","supplier":"OCB PHARMACEUTICAL SRL","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"MARKSANS PHARMA","customerCountry":"INDIA","quantity":"600.00","actualQuantity":"600","unit":"KGS","unitRateFc":"21.8","totalValueFC":"13853.6","currency":"USD","unitRateINR":"1921.7","date":"24-Oct-2023","totalValueINR":"1153027.53","totalValueInUsd":"13853.6","indian_port":"JNPT","hs_no":"29182190","bill_no":"8448708","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"BARCELONA","supplierAddress":"P.I CAN CASTELLS, CARLES BUHIGAS 5AP.O BOX No 1 08420 CANOVELLES BARCELONA, SPAIN SPAIN","customerAddress":"11TH FLOOR, LOTUS BUSINESS PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1708626600,"product":"BISMUTH SUBSALICYLATE MICRONIZED (0244) 232440902, 232440113","address":"11TH FLOOR, LOTUS BUSINESS PARK,","city":"MUMBAI,MAHARASHTRA","supplier":"OCB PHARMACEUTICAL SRL","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"MARKSANS PHARMA","customerCountry":"INDIA","quantity":"600.00","actualQuantity":"600","unit":"KGS","unitRateFc":"21.8","totalValueFC":"13847.7","currency":"USD","unitRateINR":"1915","date":"23-Feb-2024","totalValueINR":"1148993.2","totalValueInUsd":"13847.7","indian_port":"JNPT","hs_no":"29182190","bill_no":"2271016","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"BARCELONA","supplierAddress":"P.I CAN CASTELLS, CARLES BUHIGAS 5AP.O BOX No 1 08420 CANOVELLES BARCELONA SPAIN","customerAddress":"11TH FLOOR, LOTUS BUSINESS PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728585000,"product":"BISMUTH SUBSALICYLATE MICRONIZED, BATCH NO: 242440042, 242440056 & 242440057 (AS PER INVOICE)","address":"H.No.2-2-124\/124, Sri Sai Reddy Nag","city":"MEDCHAL MALKAJGIRI","supplier":"OCB PHARMACEUTICAL, SRL","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"VITACHEM PHARMA","customerCountry":"INDIA","quantity":"175.00","actualQuantity":"175","unit":"KGS","unitRateFc":"32.9","totalValueFC":"5879.3","currency":"USD","unitRateINR":"2823","date":"11-Oct-2024","totalValueINR":"494019.77","totalValueInUsd":"5879.3","indian_port":"Hyderabad Air","hs_no":"29182190","bill_no":"6068542","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"BARCELONA","supplierAddress":"P.I CAN CASTELLS, CARLES BUHIGAS 5A P.O. BOX NO.108420 CANOVELLES SDNF ES","customerAddress":"H.No.2-2-124\/124, Sri Sai Reddy Nag"}]
    06-Jul-2021
    11-Oct-2024
    KGS
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    ABOUT THIS PAGE

    Pepto-bismol Manufacturers

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

    Pepto-bismol Suppliers

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

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

    Pepto-bismol USDMF

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

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

    click here to find a list of Pepto-bismol suppliers with USDMF on PharmaCompass.

    Pepto-bismol 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 Pepto-bismol as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Pepto-bismol suppliers with NDC on PharmaCompass.

    Pepto-bismol GMP

    Pepto-bismol 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 Pepto-bismol 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 Pepto-bismol GMP manufacturer or Pepto-bismol GMP API supplier for your needs.

    Pepto-bismol CoA

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

    Pepto-bismol CoA mostly includes findings from lab analyses of a specific batch. For each Pepto-bismol 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.

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