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Chemistry

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Also known as: 299-28-5, Calcium d-gluconate, Calglucon, D-gluconic acid, calcium salt (2:1), Gluconate calcium, Calcarea gluconica
Molecular Formula
C12H22CaO14
Molecular Weight
430.37  g/mol
InChI Key
NEEHYRZPVYRGPP-IYEMJOQQSA-L
FDA UNII
SQE6VB453K

Calcium Gluconate
The calcium salt of gluconic acid. The compound has a variety of uses, including its use as a calcium replenisher in hypocalcemic states.
1 2D Structure

Calcium Gluconate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
calcium;(2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanoate
2.1.2 InChI
InChI=1S/2C6H12O7.Ca/c2*7-1-2(8)3(9)4(10)5(11)6(12)13;/h2*2-5,7-11H,1H2,(H,12,13);/q;;+2/p-2/t2*2-,3-,4+,5-;/m11./s1
2.1.3 InChI Key
NEEHYRZPVYRGPP-IYEMJOQQSA-L
2.1.4 Canonical SMILES
C(C(C(C(C(C(=O)[O-])O)O)O)O)O.C(C(C(C(C(C(=O)[O-])O)O)O)O)O.[Ca+2]
2.1.5 Isomeric SMILES
C([C@H]([C@H]([C@@H]([C@H](C(=O)[O-])O)O)O)O)O.C([C@H]([C@H]([C@@H]([C@H](C(=O)[O-])O)O)O)O)O.[Ca+2]
2.2 Other Identifiers
2.2.1 UNII
SQE6VB453K
2.3 Synonyms
2.3.1 MeSH Synonyms

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

2.3.2 Depositor-Supplied Synonyms

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]

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 430.37 g/mol
Molecular Formula C12H22CaO14
Hydrogen Bond Donor Count10
Hydrogen Bond Acceptor Count14
Rotatable Bond Count8
Exact Mass430.0635462 g/mol
Monoisotopic Mass430.0635462 g/mol
Topological Polar Surface Area283 Ų
Heavy Atom Count27
Formal Charge0
Complexity165
Isotope Atom Count0
Defined Atom Stereocenter Count8
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Drug and Medication Information
4.1 Therapeutic Uses

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.


4.2 Drug Warning

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.


4.3 Drug Indication

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.


5 Pharmacology and Biochemistry
5.1 Pharmacology

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.


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Calcium [CS]; Cations, Divalent [CS]; Increased Coagulation Factor Activity [PE]; Blood Coagulation Factor [EPC]
5.3 ATC Code

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


5.4 Absorption, Distribution and Excretion

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


5.5 Metabolism/Metabolites

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.


5.6 Mechanism of Action

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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Rev. Date : 2023-10-24

Pay. Date : 2023-10-03

DMF Number : 37213

Submission : 2023-07-05

Status : Active

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DMF Review : Complete

Rev. Date : 2021-07-13

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DMF Number : 34748

Submission : 2021-06-01

Status : Active

Type : II

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Certificate Number : R1-CEP 2001-246 - Rev 01

Status : Withdrawn by Holder

Issue Date : 2009-05-28

Type : Chemical

Substance Number : 979

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Certificate Number : R1-CEP 1995-020 - Rev 07

Status : Withdrawn by Holder

Issue Date : 2009-05-28

Type : Chemical

Substance Number : 172

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Certificate Number : R1-CEP 2005-298 - Rev 00

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Issue Date : 2012-10-01

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Substance Number : 979

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Certificate Number : R1-CEP 2002-128 - Rev 00

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Issue Date : 2008-12-04

Type : Chemical

Substance Number : 172

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Certificate Number : R0-CEP 2016-029 - Rev 00

Status : Expired

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Substance Number : 172

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Registration Number : 217MF10521

Registrant's Address : Tokushima Prefecture Naruto City Setocho Myojin Maruyama 85-1

Initial Date of Registration : 2005-09-07

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Registration Number : 306MF10018

Registrant's Address : Tokushima Prefecture Naruto City Setocho Myojin Maruyama 85-1

Initial Date of Registration : 2024-01-30

Latest Date of Registration : 2024-01-30

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Registration Number : 305MF10100

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Initial Date of Registration : 2023-08-22

Latest Date of Registration : 2023-08-22

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Date of Issue : 2022-06-08

Valid Till : 2025-07-07

Written Confirmation Number : WC-0104

Address of the Firm : #125 & 126, Sipcot Industrial Complex, Hosur-635 126, Tamilnadu 

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Date of Issue : 2022-06-06

Valid Till : 2025-07-21

Written Confirmation Number : WC-0044

Address of the Firm : A-100, A-100/1, 2 & D-1, MIDC Ind. Area, Shendra, Aurangabad-431 210

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SAVLA & ","customerCountry":"INDIA","quantity":"104000.00","actualQuantity":"104000","unit":"KGS","unitRateFc":"0.3","totalValueFC":"30762.2","currency":"N\/A","unitRateINR":"25.6","date":"29-Mar-2025","totalValueINR":"2664548.78","totalValueInUsd":"30762.2","indian_port":"Mundra","hs_no":"29181610","bill_no":"9191739","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Technical Grade","supplierPort":"SHANGHAI","supplierAddress":"., LIMITED ROOM 2105 JCD 179 TREND CENTRE 29-31 CHEUNG LEE ST CHAI WAN , HONG KONG","customerAddress":"26\/55, BANSI BHAWAN"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743186600,"product":"CALCIUM GLUCONATE CALCIUM GLUCONATE","address":"NO.1,2ND FLOOR,OPP CANARA BANK,","city":"BANGALORE","supplier":"ZHEJIANG RUIBANG LABORATORIES","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"GLOBAL CALCIUM","customerCountry":"INDIA","quantity":"8000.00","actualQuantity":"8","unit":"MTS","unitRateFc":"1550","totalValueFC":"12497.7","currency":"USD","unitRateINR":"135315","date":"29-Mar-2025","totalValueINR":"1082520","totalValueInUsd":"12497.7","indian_port":"Madras Sea","hs_no":"29181610","bill_no":"9191531","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO 578 BINHAI TEN ROAD ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE WEN ZHOU CN","customerAddress":"NO.1,2ND FLOOR,OPP CANARA BANK,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743186600,"product":"CALCIUM GLUCONATE CALCIUM GLUCONATE","address":"NO.1,2ND FLOOR,OPP CANARA BANK,","city":"BANGALORE","supplier":"ZHEJIANG RUIBANG LABORATORIES","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"GLOBAL CALCIUM","customerCountry":"INDIA","quantity":"18000.00","actualQuantity":"18","unit":"MTS","unitRateFc":"1550","totalValueFC":"28119.8","currency":"USD","unitRateINR":"135315","date":"29-Mar-2025","totalValueINR":"2435670","totalValueInUsd":"28119.8","indian_port":"Madras Sea","hs_no":"29181610","bill_no":"9191531","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO 578 BINHAI TEN ROAD ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE WEN ZHOU CN","customerAddress":"NO.1,2ND FLOOR,OPP CANARA BANK,"}]
02-Jan-2021
29-Mar-2025
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DOSAGE - SOLUTION;INTRAVENOUS - 10GM/100ML (1...DOSAGE - SOLUTION;INTRAVENOUS - 10GM/100ML (100MG/ML)

USFDA APPLICATION NUMBER - 208418

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USFDA APPLICATION NUMBER - 208418

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DOSAGE - SOLUTION;INTRAVENOUS - 5GM/50ML (100...DOSAGE - SOLUTION;INTRAVENOUS - 5GM/50ML (100MG/ML)

USFDA APPLICATION NUMBER - 208418

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ABOUT THIS PAGE

Looking for 299-28-5 / Calcium Gluconate API manufacturers, exporters & distributors?

Calcium Gluconate manufacturers, exporters & distributors 1

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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.

API | Excipient name

Calcium Gluconate

Synonyms

299-28-5, Calcium d-gluconate, Calglucon, D-gluconic acid, calcium salt (2:1), Gluconate calcium, Calcarea gluconica

Cas Number

299-28-5

Unique Ingredient Identifier (UNII)

SQE6VB453K

About Calcium Gluconate

The calcium salt of gluconic acid. The compound has a variety of uses, including its use as a calcium replenisher in hypocalcemic states.

Gluconato di calcio Manufacturers

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

Gluconato di calcio Suppliers

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

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

Gluconato di calcio USDMF

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

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

click here to find a list of Gluconato di calcio suppliers with USDMF on PharmaCompass.

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

Gluconato di calcio CEP

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

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

Gluconato di calcio WC

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

click here to find a list of Gluconato di calcio suppliers with Written Confirmation (WC) on PharmaCompass.

Gluconato di calcio GMP

Gluconato di calcio 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 Gluconato di calcio 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 Gluconato di calcio GMP manufacturer or Gluconato di calcio GMP API supplier for your needs.

Gluconato di calcio CoA

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

Gluconato di calcio CoA mostly includes findings from lab analyses of a specific batch. For each Gluconato di calcio 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.

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