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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.
API SUPPLIERS
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2022-03-10
Pay. Date : 2022-03-07
DMF Number : 29432
Submission : 2015-05-28
Status : Active
Type : II
Certificate Number : R1-CEP 2016-091 - Rev 00
Issue Date : 2022-10-25
Type : Chemical
Substance Number : 979
Status : Valid
Date of Issue : 2025-07-22
Valid Till : 2028-07-07
Written Confirmation Number : WC--0104
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-07-13
Pay. Date : 2021-05-26
DMF Number : 34748
Submission : 2021-06-01
Status : Active
Type : II
Certificate Number : R1-CEP 2012-068 - Rev 01
Issue Date : 2023-02-20
Type : Chemical
Substance Number : 979
Status : Valid
Registration Number : 305MF10100
Registrant's Address : No. 578, Binhai Ten Road, Economic and Technological Development Zone, Wenzhou, Zhejiang Province, China
Initial Date of Registration : 2023-08-22
Latest Date of Registration :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35940
Submission : 2021-05-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31690
Submission : 2017-05-23
Status : Active
Type : II
Registration Number : 217MF10521
Registrant's Address : 85-1 Maruyama, Myojin, Setocho, Naruto City, Tokushima Prefecture
Initial Date of Registration : 2005-09-07
Latest Date of Registration :
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-10-24
Pay. Date : 2023-10-03
DMF Number : 37213
Submission : 2023-07-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41142
Submission : 2025-06-05
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-05-25
Pay. Date : 2022-03-24
DMF Number : 36938
Submission : 2022-04-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8438
Submission : 1990-02-05
Status : Inactive
Type : II
Certificate Number : R1-CEP 2012-094 - Rev 01
Issue Date : 2018-09-27
Type : Chemical
Substance Number : 979
Status : Valid
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About the Company : Honour is a leading global CDMO and a trusted manufacturer of specialty chemicals and ingredients. With seven world-class facilities built to meet global safety and quality standar...
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Calcium Gluconate Monohydrate API
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About the Company : Salvi Chemical Industries Ltd. founded in 1978, is India's leading manufacturer and exporter of chemical and pharmaceutical products that includes nutritional products, intermediat...
About the Company : Sudeep Pharma Pvt. Ltd. is a leading producer of Calcium based Pharmaceutical, Food and Feed ingredients in India for the last quarter of a century. Established in 1989, we are one...
About the Company : Vasa Pharmachem Pvt. Ltd. established in the year 1988, is a part of the diversified Vasa Group of companies.Company was established to support a wide range of industries by manufa...
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Drugs in Development
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Regulatory Info : RX
Registration Country : USA
Brand Name : CALCIUM GLUCONATE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 1GM/10ML (100MG/ML)
Packaging :
Approval Date : 2017-06-15
Application Number : 208418
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : CALCIUM GLUCONATE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 5GM/50ML (100MG/ML)
Packaging :
Approval Date : 2017-06-15
Application Number : 208418
Regulatory Info : RX
Registration Country : USA
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 : DISCN
Registration Country : USA
Brand Name : CALCIUM GLUCONATE IN SODIUM CHLORIDE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 1GM/50ML (20MG/ML)
Packaging :
Approval Date : 2021-06-17
Application Number : 208418
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : CALCIUM GLUCONATE IN SODIUM CHLORIDE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 2GM/100ML (20MG/ML)
Packaging :
Approval Date : 2021-06-17
Application Number : 208418
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : CALCIUM GLUCONATE IN SODIUM CHLORIDE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 1GM/50ML (20MG/ML)
Packaging :
Approval Date : 2018-10-29
Application Number : 210906
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : CALCIUM GLUCONATE IN SODIUM CHLORIDE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 2GM/100ML (20MG/ML)
Packaging :
Approval Date : 2018-10-29
Application Number : 210906
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : CALCIUM GLUCONATE IN SODIUM CHLORIDE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 1GM/100ML (10MG/ML)
Packaging :
Approval Date : 2021-06-04
Application Number : 210906
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : CALCIUM GLUCONATE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 1GM/10ML (100MG/ML)
Packaging :
Approval Date : 2022-10-14
Application Number : 213071
Regulatory Info : RX
Registration Country : USA
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
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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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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 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.
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.
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.
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.
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.
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.
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 Gluconato di calcio as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Gluconato di calcio API and other APIs are published in this directory by the FDA.
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 Gluconato di calcio 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.
The NDC directory also contains data on finished compounded human drug products that contain Gluconato di calcio and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gluconato di calcio NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Gluconato di calcio suppliers with NDC on PharmaCompass.
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.
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).
