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1. Calciofon
2. Calcipot
3. Calcium Braun
4. Calcivitol
5. Calglucon
6. Cbg
7. Ebucin
8. Flopak Plain
9. Glucal
10. Glucobiogen
11. Gluconate De Calcium Lavoisier
12. Gluconate, Calcium
13. Gluconato Calc Fresenius
1. 299-28-5
2. Calcium D-gluconate
3. Calglucon
4. D-gluconic Acid, Calcium Salt (2:1)
5. Gluconate Calcium
6. Calcarea Gluconica
7. Calcium Di-gluconate
8. Calcium Gluconate Anhydrous
9. Gluconic Acid Calcium Salt
10. Calcium Gluconate, Anhydrous
11. Glucobiogen
12. Calciofon
13. Sqe6vb453k
14. Ins No.578
15. Ebucin
16. Gluconate De Calcium
17. Ins-578
18. Almora
19. Nsc-744619
20. 152772-65-1
21. Calcium;(2r,3s,4r,5r)-2,3,4,5,6-pentahydroxyhexanoate
22. Calcicol
23. Calcipur
24. Calglucol
25. Dragocal
26. Kalpren
27. Novocal
28. E-578
29. Calcium (2r,3s,4r,5r)-2,3,4,5,6-pentahydroxyhexanoate
30. Calcium Hexagluconate
31. 2,3,4,5,6-pentahydroxycaproic Acid Hemicalcium Salt
32. 18016-24-5
33. Gluconato Di Calcio
34. Calcium D-gluconate (1:2)
35. Gluconate De Calcium [french]
36. Gluconato Di Calcio [italian]
37. Ccris 1336
38. Hsdb 994
39. Calcium Gluconate [usan:jan]
40. Einecs 206-075-8
41. Unii-sqe6vb453k
42. Gluconic Acid, Calcium Salt
43. Calcii Gluconas
44. Gluconic Acid, Calcium Salt (2:1), D-
45. Gluconic Acid, Calcium Salt, D-
46. Mfcd00064209
47. Calcium Bis(d-gluconate)
48. Calcium Gluconate (usp)
49. L-gluconic Acid Calcium Salt
50. Schembl24132
51. Gluconic Acid Hemicalcium Salt
52. Calcium Gluconate [mi]
53. Chebi:3309
54. Calcium Gluconate [fcc]
55. Boron Gluconate Blend 5% 40m
56. Calcium Gluconate [hsdb]
57. Calcium Gluconate [inci]
58. Chembl2106119
59. Dtxsid2029618
60. Calcium Gluconate [vandf]
61. Calcium Gluconate [who-dd]
62. Calcium Gluconate [who-ip]
63. Akos015895893
64. Calcii Gluconas [who-ip Latin]
65. Calcium Gluconate [orange Book]
66. Db11126
67. Nsc 744619
68. Calcium Gluconate [usp Impurity]
69. Calcium Gluconate [usp Monograph]
70. As-80559
71. Calcium Gluconate Anhydrous [usp-rs]
72. G0037
73. C08133
74. D00935
75. A876351
76. Q413739
77. Calcium Gluconate, Anhydrous [ep Monograph]
78. W-202243
79. Calcium D-gluconate Gel, 2.5% W/w Aqueous Solution
80. Calcium Bis[(2r,3s,4r,5r)-2,3,4,5,6-pentahydroxyhexanoate]
| Molecular Weight | 430.37 g/mol |
|---|---|
| Molecular Formula | C12H22CaO14 |
| Hydrogen Bond Donor Count | 10 |
| Hydrogen Bond Acceptor Count | 14 |
| Rotatable Bond Count | 8 |
| Exact Mass | 430.0635462 g/mol |
| Monoisotopic Mass | 430.0635462 g/mol |
| Topological Polar Surface Area | 283 Ų |
| Heavy Atom Count | 27 |
| Formal Charge | 0 |
| Complexity | 165 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 8 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 3 |
Some studies have shown that calcium supplementation begun in the second trimester may be effective in lowering blood pressure in pregnancy women with pregnancy-induced hypertension or pre-eclampsia, both of which may possibly be associated with increased calcium demand of the fetus during the last trimester. /Calcium supplements/
USP Convention. USPDI-Drug Information for the Health Care Professional. 14th ed. Volume I. Rockville, MD: United States Pharmacopeial Convention, Inc., 1994. (Plus Updates)., p. 698
Oral calcium salts are used as dietary supplemental therapy for person who may not get enough calcium in their regular diet. Due to increased needs, children and pregnancy women are at greatest risk. Pre- and postmenopausal women; adolescents, especially girls and the elderly may not receive adequate calcium in their diets. ... Calcium supplements are used as part of the prevention and treatment of osteoporosis in patients with an inadequate calcium intake. The use of calcium citrate may reduce the risk of kidney stones in susceptible patients. The use of water-soluble salts of calcium (ie, citrate, gluconate, and lactate) may be preferable to acid-soluble salts (ie, carbonate and phosphate) for patients with reduced stomach acid or patients taking acid-inhibiting medication, such as the histamine H2-receptor antagonists. /Calcium supplements; Included in US product labeling/
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 742
Oral calcium supplements provide a source of calcium ion for treating calcium depletion occurring in conditions such as chronic hypoparathyroidism, pseudohypoparathyroidism, osteomalacia, rickets, chronic renal failure, and hypocalcemia secondary to the administration of anticonvulsant medications. When chronic hypocalcemia is due to vitamin D deficiency oral calcium salts may be administered concomitantly with vitamin D analogs. /Calcium supplements; Included in US product labeling/
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 742
Calcium chloride and parenteral calcium gluconate are used to decrease or reverse the cardiac depressant effects of hyperkalemia on electrocardiographic (ECG) function. /Calcium supplements; Included in US product labeling/
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 742
For more Therapeutic Uses (Complete) data for CALCIUM GLUCONATE (27 total), please visit the HSDB record page.
VET: ... Calcium gluconate ... if given by iv injection, should be admin slowly ... given rapidly ... may have toxic effect on heart.
Clarke, E.G., and M. L. Clarke. Veterinary Toxicology. Baltimore, Maryland: The Williams and Wilkins Company, 1975., p. 47
Calcium gluconate ... not recommended for im use because dose must be large and danger of sterile abscess formation is too great.
Hayes, W.J., Jr., E.R. Laws Jr., (eds.). Handbook of Pesticide Toxicology Volume 1. General Principles. New York, NY: Academic Press, Inc., 1991., p. 398
Many physicians recommend that pregnant women receive multivitamin and mineral supplements, especially those pregnant women who do not consume an adequate diet and those in high-risk categories )ie, women carrying more than one fetus, heavy cigarette smokers, and alcohol and drug abusers). Taking excessive amounts of a multivitamin and mineral supplement may be harmful to the mother and/or fetus and should be avoided. /Calcium supplements/
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 742
Side/adverse effects may be more likely to occur if oral calcium supplements are taken in much larger doses than recommended (greater than 2000 to 2500 mg a day), if they are taken for a longer period of time, or if they are taken by patients with renal function impairment or milk-alkali syndrome. /Calcium supplements/
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 744
For more Drug Warnings (Complete) data for CALCIUM GLUCONATE (15 total), please visit the HSDB record page.
Oral calcium salts are used as dietary supplemental therapy for person who may not get enough calcium in their regular diet. Calcium gluconate is used as a cardioprotective agent in high blood potassium. Calcium gluconate is the antidote for magnesium sulfate toxicity.
Calcium Gluconate is the gluconate salt of calcium. An element or mineral necessary for normal nerve, muscle, and cardiac function, calcium as the gluconate salt helps to maintain calcium balance and prevent bone loss when taken orally. This agent may also be chemopreventive for colon and other cancers.
A - Alimentary tract and metabolism
A12 - Mineral supplements
A12A - Calcium
A12AA - Calcium
A12AA03 - Calcium gluconate
D - Dermatologicals
D11 - Other dermatological preparations
D11A - Other dermatological preparations
D11AX - Other dermatologicals
D11AX03 - Calcium gluconate
Absorption
Approximately one-fifth to one-third of orally administered calcium is absorbed in the small intestine, depending on presence of vitamin D metabolites, pH in lumen, and on dietary factors, such as calcium binding to fiber or phytates. Calcium absorption is increased when a calcium deficiency is present or when a patient is on a low-calcium diet. In patients with achlorhydria or hypochlorhydria, calcium absorption, especially with the carbonate salt, may be reduced.
Route of Elimination
Renal (20%) - The amount excreted in the urine varies with degree of calcium absorption and whether there is excessive bone loss or failure of renal conservation. Fecal (80%) - Consists mainly of nonabsorbed calcium, with only a small amount of endogenous fecal calcium excreted.
Volume of Distribution
Not available
Approximately one-fifth to one-third of orally administered calcium is absorbed in the small intestine, depending on presence of vitamin D metabolites, pH in lumen, and on dietary factors, such as calcium binding to fiber or phytates. Calcium absorption is increased when a calcium deficiency is present or when a patient is on a low-calcium diet. In patients with achlorhydria or hypochlorhydria, calcium absorption, especially with the carbonate salt, may be reduced. /Calcium supplements/
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 742
Elimination: Renal (20%) - The amount excreted in the urine varies with degree of calcium absorption and whether there is excessive bone loss or failure of renal conservation. Fecal (80%) - Consists mainly of nonabsorbed calcium, with only a small amount of endogenous fecal calcium excreted. /Calcium supplements/
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 742
Calcium gluconate does not require hepatic metabolism for the release of Ca++ and is as effective as calcium chloride in treating ionic hypocalcemia in the absence of hepatic function.
Calcium is essential for the functional integrity of the nervous, muscular, and skeletal systems. It plays a role in normal cardiac function, renal function, respiration, blood coagulation, and cell membrane and capillary permeability. Also, calcium helps to regulate the release and storage of neurotransmitters and hormones, the uptake and binding of amino acids, absorption of vitamin B 12, and gastrin secretion. The major fraction (99%) of calcium is in the skeletal structure primarily as hydroxyapatite, Ca 10(PO 4) 6(OH) 2; small amounts of calcium carbonate and amorphous calcium phosphates are also present. The calcium of bone is in a constant exchange with the calcium of plasma. Since the metabolic functions of calcium are essential for life, when there is a disturbance in the calcium balance because of dietary deficiency or other causes, the stores of calcium in bone may be depleted to fill the body's more acute needs. Therefore, on a chronic basis, normal mineralization of bone depends on adequate amounts of total body calcium.
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 8438
Submission : 1990-02-05
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-24
Pay. Date : 2023-10-03
DMF Number : 37213
Submission : 2023-07-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-03-10
Pay. Date : 2022-03-07
DMF Number : 29432
Submission : 2015-05-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-25
Pay. Date : 2022-03-24
DMF Number : 36938
Submission : 2022-04-12
Status : Active
Type : II
GDUFA
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DMF Number : 31690
Submission : 2017-05-23
Status : Active
Type : II
GDUFA
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DMF Number : 24708
Submission : 2010-12-20
Status : Inactive
Type : II
GDUFA
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DMF Number : 35940
Submission : 2021-05-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-07-13
Pay. Date : 2021-05-26
DMF Number : 34748
Submission : 2021-06-01
Status : Active
Type : II
GDUFA
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DMF Number : 38969
Submission : 2023-10-09
Status : Active
Type : II
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Certificate Number : R1-CEP 2012-095 - Rev 01
Status : Valid
Issue Date : 2018-11-23
Type : Chemical
Substance Number : 172
Calcium Gluconate For Injection
Certificate Number : R1-CEP 2012-094 - Rev 01
Status : Valid
Issue Date : 2018-09-27
Type : Chemical
Substance Number : 979
Calcium Gluconate For Injection
Certificate Number : R1-CEP 2001-246 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2009-05-28
Type : Chemical
Substance Number : 979
Certificate Number : R1-CEP 1995-020 - Rev 07
Status : Withdrawn by Holder
Issue Date : 2009-05-28
Type : Chemical
Substance Number : 172
Certificate Number : R1-CEP 2002-128 - Rev 00
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2008-12-04
Type : Chemical
Substance Number : 172
Calcium Gluconate For Injection
Certificate Number : R1-CEP 2016-091 - Rev 00
Status : Valid
Issue Date : 2022-10-25
Type : Chemical
Substance Number : 979
Calcium Gluconate For Injection
Certificate Number : R1-CEP 2005-298 - Rev 00
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2012-10-01
Type : Chemical
Substance Number : 979
Certificate Number : R0-CEP 2016-029 - Rev 00
Status : Expired
Issue Date : 2017-07-18
Type : Chemical
Substance Number : 172
Calcium Gluconate For Injection
Certificate Number : R0-CEP 2020-039 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2021-04-29
Type : Chemical
Substance Number : 979
Calcium Gluconate For Injection
Certificate Number : R1-CEP 2012-068 - Rev 01
Status : Valid
Issue Date : 2023-02-20
Type : Chemical
Substance Number : 979
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Drugs in Development
Details:
Calcium gluconate in sodium chloride injection is a small volume parenteral bag indicated for the treatment of acute symptomatic hypocalcemia in pediatric and adult patients.
Lead Product(s): Calcium Gluconate
Therapeutic Area: Nephrology Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Vitamins/Minerals/Inorganic Salts
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 09, 2023
Lead Product(s) : Calcium Gluconate
Therapeutic Area : Nephrology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Amneal Receives U.S. FDA Approval for Calcium Gluconate Injection
Details : Calcium gluconate in sodium chloride injection is a small volume parenteral bag indicated for the treatment of acute symptomatic hypocalcemia in pediatric and adult patients.
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
June 09, 2023
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Regulatory Info : OTC
Registration Country : Canada
Brand Name : CALCI-MAG-PHOS-DEXTROSE
Dosage Form : SOLUTION
Dosage Strength : 20.55%/W/V
Packaging :
Approval Date :
Application Number : 2518872
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : RX
Registration Country : USA
Brand Name : CALCIUM GLUCONATE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 10GM/100ML (100MG/ML)
Packaging :
Approval Date : 2024-05-10
Application Number : 216611
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 10%
Packaging :
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Regulatory Info :
Registration Country : India
Regulatory Info : OTC
Registration Country : Canada
Brand Name : CAL-MAG PLUS
Dosage Form : SOLUTION
Dosage Strength : 20.55%/W/V
Packaging : 500ML
Approval Date :
Application Number : 2478552
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : RX
Registration Country : USA
Brand Name : CALCIUM GLUCONATE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 10GM/100ML (100MG/ML)
Packaging :
Approval Date : 2017-06-15
Application Number : 208418
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 10%/10ML
Packaging : 10ml Ampoule
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Brand Name : CALCIUM GLUCONATE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 5GM/50ML (100MG/ML)
Packaging :
Approval Date : 2023-10-19
Application Number : 213071
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Complenatal FF
Dosage Form : CAP
Dosage Strength : 350mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : RX
Registration Country : USA
Brand Name : CALCIUM GLUCONATE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 5GM/50ML (100MG/ML)
Packaging :
Approval Date : 2023-10-19
Application Number : 217689
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Italy
Brand Name : Calcium Gluconate
Dosage Form :
Dosage Strength : 5 Ampoule 500 Mg 5 Ml
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Registration Country : Italy
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Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 10%
Packaging :
Approval Date :
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Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 10%
Brand Name :
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Registration Country : India
Regulatory Info : Generic
Registration Country :
Brand Name :
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 10% W/V
Packaging : 10 ML
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Regulatory Info : Generic
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Registration Country : Canada
Sodium DNA; Sodium Hyaluronate; Sodium Chloride; GLYCERIN; GLUCONOLACTONE; Sodium Benzoate; Calcium Gluconate
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Dosage Form : Solution
Dosage Strength :
Packaging :
Approval Date :
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Registration Country : Canada
Packaging :
Regulatory Info :
Sodium DNA; Sodium Hyaluronate; Sodium Chloride; GLYCERIN; GLUCONOLACTONE; Sodium Benzoate; Calcium Gluconate
Dosage : Solution
Dosage Strength :
Brand Name :
Approval Date :
Application Number :
Registration Country : Canada
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 10%/10ML
Packaging : 10ml Ampoule
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging : 10ml Ampoule
Regulatory Info :
Dosage : Injection
Dosage Strength : 10%/10ML
Brand Name :
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Registration Country : India
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Intravenous Vial
Dosage Strength : 100MG/ML
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Approval Date :
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Regulatory Info :
Registration Country : Spain
Packaging :
Regulatory Info :
Dosage : Intravenous Vial
Dosage Strength : 100MG/ML
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Registration Country : Spain
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Registration Country : China
Brand Name :
Dosage Form : Injection
Dosage Strength : 1G/10ML
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Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 1G/10ML
Brand Name :
Approval Date :
Application Number :
Registration Country : China
Regulatory Info :
Registration Country : China
Brand Name :
Dosage Form : Injection
Dosage Strength : 1G/10ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 1G/10ML
Brand Name :
Approval Date :
Application Number :
Registration Country : China
Regulatory Info :
Registration Country : India
Malt sugar; Ferric Ammonium Citrate; Calcium Gluconate; Cholecalciferols; Niacinamide; Folic Acid; Cyanocobalamin
Brand Name : Megaferrol Ca-Fe & Vit...
Dosage Form : Syrup
Dosage Strength : 4.52g/15; 100mg/15; 36...
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Malt sugar; Ferric Ammonium Citrate; Calcium Gluconate; Cholecalciferols; Niacinamide; Folic Acid; Cyanocobalamin
Dosage : Syrup
Dosage Strength : 4.52g/15; 100mg/15; 36...
Brand Name : Megaferrol Ca-Fe & Vit...
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Malt sugar; Ferric Ammonium Citrate; Calcium Gluconate; Cholecalciferol; Niacinamide; Folic Acid; Cyanocobalamin
Brand Name : Hexaferrol
Dosage Form : Syrup
Dosage Strength : 4.52g/15ml; 100/15ml;...
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Malt sugar; Ferric Ammonium Citrate; Calcium Gluconate; Cholecalciferol; Niacinamide; Folic Acid; Cyanocobalamin
Dosage : Syrup
Dosage Strength : 4.52g/15ml; 100/15ml;...
Brand Name : Hexaferrol
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : China
Brand Name : Calon-250
Dosage Form : Liquid Injection
Dosage Strength : 25%
Packaging : 100ML
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Packaging : 100ML
Regulatory Info :
Dosage : Liquid Injection
Dosage Strength : 25%
Brand Name : Calon-250
Approval Date :
Application Number :
Registration Country : China
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - SOLUTION;INTRAVENOUS - 10GM/100ML (1...DOSAGE - SOLUTION;INTRAVENOUS - 10GM/100ML (100MG/ML)
USFDA APPLICATION NUMBER - 208418
DOSAGE - SOLUTION;INTRAVENOUS - 1GM/10ML (100...DOSAGE - SOLUTION;INTRAVENOUS - 1GM/10ML (100MG/ML)
USFDA APPLICATION NUMBER - 208418
DOSAGE - SOLUTION;INTRAVENOUS - 1GM/50ML (20M...DOSAGE - SOLUTION;INTRAVENOUS - 1GM/50ML (20MG/ML)
USFDA APPLICATION NUMBER - 208418
DOSAGE - SOLUTION;INTRAVENOUS - 2GM/100ML (20...DOSAGE - SOLUTION;INTRAVENOUS - 2GM/100ML (20MG/ML)
USFDA APPLICATION NUMBER - 208418
DOSAGE - SOLUTION;INTRAVENOUS - 5GM/50ML (100...DOSAGE - SOLUTION;INTRAVENOUS - 5GM/50ML (100MG/ML)
USFDA APPLICATION NUMBER - 208418
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Evonik
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Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Microlose (Lactose Monohydrate & Microcrystalline Cellulose) is used as a diluent in oral dosage forms such as tablets.
Pharmacopoeia Ref : DMF, EXCiPAT, KOSHER, HALAL, W...
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Lactose Monohydrate
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Capsule
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : ProBlend (SMCC) is a co-processed excipient consists of microcrystalline cellulose & colloidal silicon dioxide, used as a diluent & binder in OSDs.
Pharmacopoeia Ref : USP-NF, DMF, EXCiPAT, KOSHER, ...
Technical Specs : NA
Ingredient(s) : Silicified Microcrystalline Cellulose
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PharmaCompass offers a list of Calcium Gluconate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Calcium Gluconate manufacturer or Calcium Gluconate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Calcium Gluconate manufacturer or Calcium Gluconate supplier.
PharmaCompass also assists you with knowing the Calcium Gluconate API Price utilized in the formulation of products. Calcium Gluconate API Price is not always fixed or binding as the Calcium Gluconate Price is obtained through a variety of data sources. The Calcium Gluconate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fresenius Kabi Brand of Calcium Gluconate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fresenius Kabi Brand of Calcium Gluconate, including repackagers and relabelers. The FDA regulates Fresenius Kabi Brand of Calcium Gluconate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fresenius Kabi Brand of Calcium Gluconate 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 Fresenius Kabi Brand of Calcium Gluconate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fresenius Kabi Brand of Calcium Gluconate supplier is an individual or a company that provides Fresenius Kabi Brand of Calcium Gluconate active pharmaceutical ingredient (API) or Fresenius Kabi Brand of Calcium Gluconate finished formulations upon request. The Fresenius Kabi Brand of Calcium Gluconate suppliers may include Fresenius Kabi Brand of Calcium Gluconate API manufacturers, exporters, distributors and traders.
click here to find a list of Fresenius Kabi Brand of Calcium Gluconate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fresenius Kabi Brand of Calcium Gluconate DMF (Drug Master File) is a document detailing the whole manufacturing process of Fresenius Kabi Brand of Calcium Gluconate active pharmaceutical ingredient (API) in detail. Different forms of Fresenius Kabi Brand of Calcium Gluconate DMFs exist exist since differing nations have different regulations, such as Fresenius Kabi Brand of Calcium Gluconate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fresenius Kabi Brand of Calcium Gluconate DMF submitted to regulatory agencies in the US is known as a USDMF. Fresenius Kabi Brand of Calcium Gluconate USDMF includes data on Fresenius Kabi Brand of Calcium Gluconate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fresenius Kabi Brand of Calcium Gluconate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fresenius Kabi Brand of Calcium Gluconate suppliers with USDMF on PharmaCompass.
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 Fresenius Kabi Brand of Calcium Gluconate Drug Master File in Japan (Fresenius Kabi Brand of Calcium Gluconate JDMF) empowers Fresenius Kabi Brand of Calcium Gluconate 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 Fresenius Kabi Brand of Calcium Gluconate JDMF during the approval evaluation for pharmaceutical products. At the time of Fresenius Kabi Brand of Calcium Gluconate 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 Fresenius Kabi Brand of Calcium Gluconate suppliers with JDMF on PharmaCompass.
A Fresenius Kabi Brand of Calcium Gluconate CEP of the European Pharmacopoeia monograph is often referred to as a Fresenius Kabi Brand of Calcium Gluconate Certificate of Suitability (COS). The purpose of a Fresenius Kabi Brand of Calcium Gluconate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fresenius Kabi Brand of Calcium Gluconate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fresenius Kabi Brand of Calcium Gluconate to their clients by showing that a Fresenius Kabi Brand of Calcium Gluconate CEP has been issued for it. The manufacturer submits a Fresenius Kabi Brand of Calcium Gluconate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fresenius Kabi Brand of Calcium Gluconate CEP holder for the record. Additionally, the data presented in the Fresenius Kabi Brand of Calcium Gluconate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fresenius Kabi Brand of Calcium Gluconate DMF.
A Fresenius Kabi Brand of Calcium Gluconate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fresenius Kabi Brand of Calcium Gluconate 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 Fresenius Kabi Brand of Calcium Gluconate suppliers with CEP (COS) on PharmaCompass.
A Fresenius Kabi Brand of Calcium Gluconate written confirmation (Fresenius Kabi Brand of Calcium Gluconate WC) is an official document issued by a regulatory agency to a Fresenius Kabi Brand of Calcium Gluconate manufacturer, verifying that the manufacturing facility of a Fresenius Kabi Brand of Calcium Gluconate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fresenius Kabi Brand of Calcium Gluconate APIs or Fresenius Kabi Brand of Calcium Gluconate finished pharmaceutical products to another nation, regulatory agencies frequently require a Fresenius Kabi Brand of Calcium Gluconate WC (written confirmation) as part of the regulatory process.
click here to find a list of Fresenius Kabi Brand of Calcium Gluconate suppliers with Written Confirmation (WC) on PharmaCompass.
Fresenius Kabi Brand of Calcium Gluconate 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 Fresenius Kabi Brand of Calcium Gluconate 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 Fresenius Kabi Brand of Calcium Gluconate GMP manufacturer or Fresenius Kabi Brand of Calcium Gluconate GMP API supplier for your needs.
A Fresenius Kabi Brand of Calcium Gluconate CoA (Certificate of Analysis) is a formal document that attests to Fresenius Kabi Brand of Calcium Gluconate's compliance with Fresenius Kabi Brand of Calcium Gluconate specifications and serves as a tool for batch-level quality control.
Fresenius Kabi Brand of Calcium Gluconate CoA mostly includes findings from lab analyses of a specific batch. For each Fresenius Kabi Brand of Calcium Gluconate 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.
Fresenius Kabi Brand of Calcium Gluconate may be tested according to a variety of international standards, such as European Pharmacopoeia (Fresenius Kabi Brand of Calcium Gluconate EP), Fresenius Kabi Brand of Calcium Gluconate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fresenius Kabi Brand of Calcium Gluconate USP).
