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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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CBG

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Calcium Gluconate

About the Company : Eagle Chemical was founded in the year 1978 by Gautam Shah a man with an enterprising zeal & a vision to make a mark in the nascent pharmaceutical raw material manufacturing sector...

Eagle Chemical was founded in the year 1978 by Gautam Shah a man with an enterprising zeal & a vision to make a mark in the nascent pharmaceutical raw material manufacturing sector. His vision was to make the finest products for the pharmaceutical and food industry which could be exported all across the world. Since then Eagle Chemical Works [ECW] has a long wasy in the journey of 35 years. We have set goals of serving value to the Indian and Overseas pharmaceutical and food industry.
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05

CPHI Middle east
Not Confirmed
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CPHI Middle east
Not Confirmed

Calcium Gluconate

About the Company : Maithri Drugs is one of India's fast-growing pharmaceutical companies. Maithri's strategic focus is on active pharma ingredients (APIs). The company is widely recognized for its ex...

Maithri Drugs is one of India's fast-growing pharmaceutical companies. Maithri's strategic focus is on active pharma ingredients (APIs). The company is widely recognized for its excellent research & development and aggressive growth strategies. Our 32 US DMFs and 9 CEPs in a short span attest to our R&D excellence. Maithri's manufacturing facility is located in Hyderabad. This facility is audited and approved by the US FDA. In addition, our facility is certified according to the standards of DCGI, WHO GMP, and ISO 9001:2015 We have a portfolio of 65 products and are continually expanding.
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06

Raks Pharma

India
CPHI Middle east
Not Confirmed
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Raks Pharma

India
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CPHI Middle east
Not Confirmed

Calcium Gluconate Monohydrate API

About the Company : Founded by a group of highly committed Technocrats in year 2009, today Raks Pharma is a partner of choice for pharmaceutical companies across the globe to source Active Pharmaceuti...

Founded by a group of highly committed Technocrats in year 2009, today Raks Pharma is a partner of choice for pharmaceutical companies across the globe to source Active Pharmaceuticals Ingredients and their intermediates. Till date the company has invested around US $ 50M and has filed 23 US DMFs and 1 CEP with US and European Authority's respectively. The manufacturing facility is also approved by USFDA and WHO. We at Raks are dedicated to develop and manufacture active pharmaceutical ingredients and intermediates. We are committed to create value through intellectual property, quality systems and customer relation across the globe.
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07

Shanpar

India
CPHI Middle east
Not Confirmed
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Shanpar

India
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CPHI Middle east
Not Confirmed

Calcium Gluconate

About the Company : SHANPAR’S strengths in quality, reliability, Consistency and commitments is reflected in its clientele which includes INTERVET, ABOTT LABS., CIBA SPECIALITIES, MERCK, NOVARTIES, ...

SHANPAR’S strengths in quality, reliability, Consistency and commitments is reflected in its clientele which includes INTERVET, ABOTT LABS., CIBA SPECIALITIES, MERCK, NOVARTIES, NICHOLAS, PFIZER, PHARMACIA, PROBIOTICS & WOCKHARDT. With a modest beginning twenty five years ago as a manufacturer of Calcium Gluconate by electrochemistry SHANPAR has diversified its activities with continuous development and introduction of newer molecules in the field of Nutraceuticals, Mineral Fortifiers, Feed Additives and Speciality Chemicals.
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08

CPHI Middle east
Not Confirmed
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CPHI Middle east
Not Confirmed

Calcium Gluconate

About the Company : Sichuan Renan Pharmaceutical Co., Ltd., founded in June 2013 with 325 acres and more than 1000 employees , located in Yuechi Pharmaceutical Industrial Park, Guangan city Sichuan pr...

Sichuan Renan Pharmaceutical Co., Ltd., founded in June 2013 with 325 acres and more than 1000 employees , located in Yuechi Pharmaceutical Industrial Park, Guangan city Sichuan province,China , is a wholly-owned subsidiary of Chengdu Brilliant Pharmaceutical Co., Ltd group. Renan Pharma is PMDA and EU approved , it is a high-tech innovative enterprise committed to the research & development, producing and sales of high-tech APIs and intermediates for global.
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09

CPHI Middle east
Not Confirmed
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CPHI Middle east
Not Confirmed

Calcium Gluconate

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...

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 of the country’s largest manufacturers and exporters of Calcium Phosphates and Calcium Carbonate. With an annual manufacturing capacity of 10,000MT, we deliver Pharma, Food and Feed ingredient solutions to over 750 customers across 30 countries. Quality is one of the most important aspects of our corporate philosophy. We strictly adhere to the guidelines set in our quality manual to ensure consistent production, quality and optimum client satisfaction.
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10

CPHI Middle east
Not Confirmed
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CPHI Middle east
Not Confirmed

Calcium D-gluconate monohydrate

About the Company : 30+ year old company possessing and continuously innovating its expertise in Stabilized Vitamins, Herbal Extracts & Formulations, Food Supplements, Tasteless Minerals and API's. Ou...

30+ year old company possessing and continuously innovating its expertise in Stabilized Vitamins, Herbal Extracts & Formulations, Food Supplements, Tasteless Minerals and API's. Our Pharma division specialises in manufacturing Active Pharmaceutical Ingredients (APIs) and stabilised vitamins. Over the past 33+ years, through our advanced R&D facility, we have been continuously enhancing the ingredients used in the manufacture of formulations.
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02-Jan-2021
31-Oct-2024
KGS
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Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

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Drugs in Development

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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: Nutrition and Weight Loss Brand Name: Undisclosed

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 06, 2023

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01

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

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.

Brand Name : Undisclosed

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 06, 2023

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FDF Dossiers

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01

Medichem S.A

Spain
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CPHI Middle east
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

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Regulatory Info :

Registration Country : Spain

Calcium Gluconate

Brand Name :

Dosage Form : Intravenous Vial

Dosage Strength : 100MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

Medichem

02

CPHI Middle east
Not Confirmed
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CPHI Middle east
Not Confirmed

CALCIUM GLUCONATE

Brand Name : CALCIUM BOROGLUCONATE 23% INJECTION

Dosage Form : SOLUTION

Dosage Strength : 20.54%/W/V

Packaging : 500ML/1L

Approval Date :

Application Number : 2475502

Regulatory Info : OTC

Registration Country : Canada

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03

CPHI Middle east
Not Confirmed
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CPHI Middle east
Not Confirmed

CALCIUM GLUCONATE

Brand Name : CALCIUM GLUCONATE

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 5GM/50ML (100MG/ML)

Packaging :

Approval Date : 2024-05-10

Application Number : 216611

Regulatory Info : RX

Registration Country : USA

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04

CPHI Middle east
Not Confirmed
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CPHI Middle east
Not Confirmed

CALCIUM GLUCONATE

Brand Name : CALCIUM GLUCONATE IN SODIUM CHLORIDE

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 2GM/100ML (20MG/ML)

Packaging :

Approval Date : 2023-09-05

Application Number : 217174

Regulatory Info : RX

Registration Country : USA

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05

CPHI Middle east
Not Confirmed
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CPHI Middle east
Not Confirmed

CALCIUM GLUCONATE

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

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CPHI Middle east
Not Confirmed
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CPHI Middle east
Not Confirmed

Calcium Gluconate; Vitamin D3

Brand Name : Beejuvit D+Calci

Dosage Form : Oral Solution

Dosage Strength : 200MG/10ML; 100IU/10ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Vietnam

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07

CPHI Middle east
Not Confirmed
arrow
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CPHI Middle east
Not Confirmed

Calcium Gluconate

Brand Name :

Dosage Form : Injection

Dosage Strength :

Packaging : 20ml Amp

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Korea

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08

Nivagen

U.S.A
CPHI Middle east
Not Confirmed
arrow

Nivagen

U.S.A
arrow
CPHI Middle east
Not Confirmed

CALCIUM GLUCONATE

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

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09

CPHI Middle east
Not Confirmed
arrow
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CPHI Middle east
Not Confirmed

Calcium gluconate

Brand Name : Complenatal FF

Dosage Form : CAP

Dosage Strength : 350mg

Packaging : 90X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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10

Zuma Pharma

Uzbekistan
CPHI Middle east
Not Confirmed
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Zuma Pharma

Uzbekistan
arrow
CPHI Middle east
Not Confirmed

Calcium Gluconate

Brand Name :

Dosage Form : Tablet

Dosage Strength : 0.5GM

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Uzbekistan

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Europe

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01

Farmak JSC

Ukraine
CPHI Middle east
Not Confirmed
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Farmak JSC

Ukraine
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CPHI Middle east
Not Confirmed

Calcium Gluconate

Brand Name : Calcium gluconate

Dosage Form : Solution for Injection

Dosage Strength : 100MG/ML

Packaging : 5ML, 10ML

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Ukraine

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02

CPHI Middle east
Not Confirmed
arrow
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CPHI Middle east
Not Confirmed

Calcium Gluconate

Brand Name : Calcium Gluconate

Dosage Form :

Dosage Strength : 1 Vial 5 Ml 10%  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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03

MONICO SpA

Country
CPHI Middle east
Not Confirmed
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MONICO SpA

Country
arrow
CPHI Middle east
Not Confirmed

Calcium Gluconate

Brand Name : Calcium Gluconate

Dosage Form :

Dosage Strength : 5 Ampoule 500 Mg 5 Ml  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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04

SALF SpA

Country
CPHI Middle east
Not Confirmed
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SALF SpA

Country
arrow
CPHI Middle east
Not Confirmed

Calcium Gluconate

Brand Name : Calcium Gluconate

Dosage Form :

Dosage Strength : 5 Ampoules 5 Ml 10%  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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05

MONICO SpA

Country
CPHI Middle east
Not Confirmed
arrow

MONICO SpA

Country
arrow
CPHI Middle east
Not Confirmed

Calcium Gluconate

Brand Name : Calcium Gluconate

Dosage Form :

Dosage Strength : 5 Vials 10 Ml 10%  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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06

SALF SpA

Country
CPHI Middle east
Not Confirmed
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SALF SpA

Country
arrow
CPHI Middle east
Not Confirmed

Calcium Gluconate

Brand Name : Calcium Gluconate

Dosage Form :

Dosage Strength : 5 Vials 10 Ml 10%  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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07

SIT LABORATORIO FARMAC. Srl

Country
CPHI Middle east
Not Confirmed
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SIT LABORATORIO FARMAC. Srl

Country
arrow
CPHI Middle east
Not Confirmed

Sodium Fluoride; Calcium Gluconate

Brand Name : Otofluor

Dosage Form :

Dosage Strength : 100 Cpr Gastrores 250 Mg + 10 Mg  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Listed Dossiers

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Medichem S.A

Spain
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CPHI Middle east
Not Confirmed
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Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

Flag Spain
Digital Content Digital Content

Regulatory Info :

Registration Country : Spain

Calcium Gluconate

Brand Name :

Dosage Form : Intravenous Vial

Dosage Strength : 100MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

Medichem

01

Medichem S.A

Spain
arrow
CPHI Middle east
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

Flag Spain
Digital Content Digital Content

Packaging :

Regulatory Info :

Calcium Gluconate

Dosage : Intravenous Vial

Dosage Strength : 100MG/ML

Brand Name :

Approval Date :

Application Number :

Registration Country : Spain

Medichem

02

Demo S.A.

Greece
CPHI Middle east
Not Confirmed
arrow

Demo S.A.

Greece
arrow
CPHI Middle east
Not Confirmed

Calcium Gluconate

Brand Name :

Dosage Form : SOLUTION FOR INJECTION

Dosage Strength : 10% W/V

Packaging : 10 ML

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country :

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02

Demo S.A.

Greece
CPHI Middle east
Not Confirmed
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Demo S.A.

Greece
arrow
CPHI Middle east
Not Confirmed

Calcium Gluconate

Dosage : SOLUTION FOR INJECTION

Dosage Strength : 10% W/V

Brand Name :

Approval Date :

Application Number :

Registration Country :

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03

Estilad

Canada
CPHI Middle east
Not Confirmed
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Estilad

Canada
arrow
CPHI Middle east
Not Confirmed

Sodium DNA; Sodium Hyaluronate; Sodium Chloride; GLYCERIN; GLUCONOLACTONE; Sodium Benzoate; Calcium Gluconate

Brand Name :

Dosage Form : Solution

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Canada

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03

Estilad

Canada
CPHI Middle east
Not Confirmed
arrow

Estilad

Canada
arrow
CPHI Middle east
Not Confirmed

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

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04

CPHI Middle east
Not Confirmed
arrow
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CPHI Middle east
Not Confirmed

Calcium Gluconate; Sodium Chloride

Brand Name :

Dosage Form : Injection; Injection

Dosage Strength : 50ML; 100ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : China

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04

CPHI Middle east
Not Confirmed
arrow
arrow
CPHI Middle east
Not Confirmed

Calcium Gluconate; Sodium Chloride

Dosage : Injection; Injection

Dosage Strength : 50ML; 100ML

Brand Name :

Approval Date :

Application Number :

Registration Country : China

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05

CPHI Middle east
Not Confirmed
arrow
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CPHI Middle east
Not Confirmed

Calcium Gluconate; Calcium Lactate; Vitamin D3; Vitamin B12; Choline Chloride

Brand Name : Procal-ID

Dosage Form : Liquid

Dosage Strength : 250MG; 200MG; 1000IU; ...

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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05

CPHI Middle east
Not Confirmed
arrow
arrow
CPHI Middle east
Not Confirmed

Calcium Gluconate; Calcium Lactate; Vitamin D3; Vitamin B12; Choline Chloride

Dosage : Liquid

Dosage Strength : 250MG; 200MG; 1000IU; ...

Brand Name : Procal-ID

Approval Date :

Application Number :

Registration Country : India

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06

JW Pharmaceutical

South Korea
CPHI Middle east
Not Confirmed
arrow

JW Pharmaceutical

South Korea
arrow
CPHI Middle east
Not Confirmed

Calcium Gluconate

Brand Name :

Dosage Form : Injection

Dosage Strength :

Packaging : 20ml Amp

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Korea

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06

JW Pharmaceutical

South Korea
CPHI Middle east
Not Confirmed
arrow

JW Pharmaceutical

South Korea
arrow
CPHI Middle east
Not Confirmed

Calcium Gluconate

Dosage : Injection

Dosage Strength :

Brand Name :

Approval Date :

Application Number :

Registration Country : South Korea

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07

CPHI Middle east
Not Confirmed
arrow
arrow
CPHI Middle east
Not Confirmed

Calcium Gluconate

Brand Name :

Dosage Form : Injection

Dosage Strength : 10%/10ML

Packaging : 10ml Ampoule

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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07

CPHI Middle east
Not Confirmed
arrow
arrow
CPHI Middle east
Not Confirmed

Calcium Gluconate

Dosage : Injection

Dosage Strength : 10%/10ML

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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08

CPHI Middle east
Not Confirmed
arrow
arrow
CPHI Middle east
Not Confirmed

Calcium Gluconate

Brand Name :

Dosage Form : Injection

Dosage Strength : 1G/10ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : China

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08

CPHI Middle east
Not Confirmed
arrow
arrow
CPHI Middle east
Not Confirmed

Calcium Gluconate

Dosage : Injection

Dosage Strength : 1G/10ML

Brand Name :

Approval Date :

Application Number :

Registration Country : China

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09

CPHI Middle east
Not Confirmed
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CPHI Middle east
Not Confirmed

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

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09

CPHI Middle east
Not Confirmed
arrow
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CPHI Middle east
Not Confirmed

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

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10

CPHI Middle east
Not Confirmed
arrow
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CPHI Middle east
Not Confirmed

Calcium Gluconate; Zinc Gluconate

Brand Name :

Dosage Form : Oral Solution

Dosage Strength :

Packaging : 10mLx12vials

Approval Date :

Application Number :

Regulatory Info :

Registration Country : China

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10

CPHI Middle east
Not Confirmed
arrow
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CPHI Middle east
Not Confirmed

Calcium Gluconate; Zinc Gluconate

Dosage : Oral Solution

Dosage Strength :

Brand Name :

Approval Date :

Application Number :

Registration Country : China

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DRUG PRODUCT COMPOSITIONS

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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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DOSAGE - SOLUTION;INTRAVENOUS - 1GM/10ML (100...DOSAGE - SOLUTION;INTRAVENOUS - 1GM/10ML (100MG/ML)

USFDA APPLICATION NUMBER - 208418

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DOSAGE - SOLUTION;INTRAVENOUS - 1GM/50ML (20M...DOSAGE - SOLUTION;INTRAVENOUS - 1GM/50ML (20MG/ML)

USFDA APPLICATION NUMBER - 208418

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DOSAGE - SOLUTION;INTRAVENOUS - 2GM/100ML (20...DOSAGE - SOLUTION;INTRAVENOUS - 2GM/100ML (20MG/ML)

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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01

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Medlab Asia & Asia Health
Not Confirmed
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Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Grade : Parenteral

Category : Parenteral

02

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Medlab Asia & Asia Health
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Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.

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Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.

Grade : Oral

Category : Controlled & Modified Release

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DATA COMPILATION #PharmaFlow

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Excipient Market Overview: Roquette, Seqens, Evonik make strategic moves; new guidelines deal with contamination
The pharmaceutical industry has long recognized the critical role excipients or inactive ingredients play in drug formulation and delivery. Excipients can comprise up to 90 percent of a medicine's total ingredients and serve crucial functions as binders, disintegrants, coatings, preservatives, colors, and flavorings. According to recent market research, the pharmaceutical excipients market was valued at US$ 9.27 billion in 2023. It is growing at a compound annual growth rate (CAGR) of 7.03 percent and is projected to reach US$ 18.48 billion by 2032. The main factors driving market growth is an increased demand for multifunctional excipients, coupled with the expanding use of generic medications. The development in the biologics sector and advancements in nanotechnology are also contributing significantly to market growth. Major excipient providers include BASF, Evonik, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, Roquette Frères, DuPont, Croda International, Seqens, Boai NKY Pharmaceuticals, PMC Isochem, Minakem, Kewpie Corporation, Ashland Global, SPI Pharma, Pfanstiehl, Nanjing Well Pharmaceutical, ICE Pharma, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) WHO, India’s CDSCO tighten regulations; new GMP guidelines implemented to curb contamination Last year, the World Health Organization (WHO) issued a health alert linking at least 300 child deaths in the Gambia, Uzbekistan, and Indonesia to the ingestion of contaminated cough syrups containing unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG). In response to the tragic events, the WHO released two draft appendices to its guideline on good manufacturing practices (GMPs) for excipients this year. Manufacturers are now required to use suitable risk assessment tools to identify and mitigate potential hazards.  Since India-made cough syrups had been linked to the deaths, India’s drug regulator — Central Drugs Standard Control Organization (CDSCO) — took steps to prevent contamination, and advised drugmakers to only use pharmaceutical-grade excipients from approved sources. Furthermore, the Indian Health Ministry proposed amendments to the Drugs and Cosmetics Rules, 1945 to include details of excipients on drug labels. While listing all excipients on every strip of medicine may be challenging, the ministry suggested mentioning those causing hypersensitivity on the label. Applicants now mandatorily need to submit evidence of stability and safety of excipients. These regulatory developments have significant implications for excipient manufacturers and pharmaceutical companies worldwide. Leading pharmaceutical excipient firms like Gangwal Healthcare, Sigachi Industries, and Nitika Pharmaceuticals are well-positioned to meet these heightened quality and safety standards, given their long-standing commitment to producing high-quality, compliant excipients.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Roquette buys IFF’s pharma unit for US$ 2.85 bn; Evonik opens new spray-drying facility in Darmstadt In a significant industry move, France-based Roquette entered into an agreement to acquire IFF's pharma solutions business in a deal valued at US$ 2.85 billion. This acquisition is set to rebalance family-owned Roquette’s portfolio around health and nutrition. The deal is expected to accelerate Roquette’s growth and significantly strengthen its presence in the excipients market. Evonik has opened a new facility for drying aqueous dispersions of its Eudragit polymers at its site in Darmstadt, Germany. The facility will help Evonik meet increasing demand from drugmakers for its oral drug delivery solutions. The plant uses green energy solutions. The company has also partnered University of Mainz to commercialize a new class of polyethylene glycols (PEG) lipids for nucleic acid delivery. Evonik’s Health Care business has been growing its nucleic acid drug and vaccine delivery portfolio.  Germany’s Johannes Gutenberg University of Mainz was the first to develop randomized polyethylene glycols (rPEGs). This collaboration aims to expand Evonik’s toolbox of technologies for nucleic acid-based medicines, offering an improved immunogenicity profile for lipid nanoparticle carriers used in mRNA vaccines and therapeutics. Asahi Kasei made significant strides in addressing a pressing industry concern that emerged in 2018 when potentially carcinogenic nitrosamine impurities were detected in several pharmaceuticals. Guided by regional authorities, such as the European Medicines Agency and the US Food and Drug Administration, the pharmaceutical industry has been carrying out extensive assessments and research to identify the cause of these impurities. In response to this challenge, Asahi Kasei developed its Ceolus microcrystalline cellulose with extremely low nitrite levels. The Japanese company achieved nitrite concentrations of 0.1 micrograms per gram or less, which is equivalent to 0.1 parts per million (ppm). The company also started full commercial operation of its second manufacturing facility for Ceolus in Japan, enhancing supply capacity and stability. JRS Pharma and Gujarat Microwax opened a state-of-the-art cotton-based croscarmellose sodium plant in Mehsana, Gujarat (India). This facility aims to produce high-quality excipients that meet global standards, potentially reducing India's dependency on imports and boosting its presence in the global excipient market. The Indian excipient industry accounts for less than 1 percent of the global market share.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Seqens to advance innovative polymer; biologics, personalized medicine create demand for specialized excipients Recent industry collaborations highlight the ongoing innovation in novel excipients. France’s Seqens, with over 20 years of polymer development experience, was chosen by Pleryon Therapeutics to advance its leading osteoarthritis candidate – an innovative GMP polymer. This collaboration leverages Seqens’ newly expanded and modernized cGMP plant in Aramon, France, demonstrating the industry’s commitment to investing in advanced manufacturing capabilities for novel excipients.  The rise of biologics and personalized medicine has created a demand for specialized excipients capable of stabilizing complex molecules and enabling targeted drug delivery. Roquette’s launch of Lycagel Flex, a hydroxypropyl pemix for nutraceutical and pharmaceutical softgel capsules, exemplifies this trend. Built on Roquette’s market-first Lycagel pea starch technology, this plant-based alternative to gelatin offers manufacturers the flexibility to customize formulations for a range of production and end-user needs. The innovative pea starch foundation also underscores the industry’s move towards sustainable bio-based excipients. The trend towards patient-centric drug development has also influenced excipient innovation. Excipients that can improve palatability, ease of swallowing, or enable novel dosage forms (such as orally disintegrating tablets) are in high demand. For example, IFF brought a super disintegrant Ac-Di-Sol, that supports faster disintegration and drug dissolution in oral disintegrating tablets, improving patient experience.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Our view The heightened regulatory scrutiny on excipients due to product contamination incidents has created a high risk perception and uncertainty around the regulatory acceptance of novel excipients. That said, novel excipients are central to the development of new drug modalities and therapies. Going forward, sustainability will also become an increasingly important factor in excipient selection and development. As the industry innovates towards biologics, personalized therapies, and patient-centric formulations, the role of high-quality, multifunctional excipients will only grow more vital in ensuring drug stability, bioavailability, and patient compliance. Companies that can navigate the complex regulatory landscape, invest in R&D, and offer high-quality, multifunctional excipients will be well-positioned to succeed in this evolving market.   

Impressions: 1678

https://www.pharmacompass.com/radio-compass-blog/excipient-market-overview-roquette-seqens-evonik-make-strategic-moves-new-guidelines-deal-with-contamination

#PharmaFlow by PHARMACOMPASS
12 Sep 2024

NEWS #PharmaBuzz

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Global Sales Information

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US Medicaid Prescriptions

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Medlab Asia & Asia Health
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Company :

Calcium Gluconate

Drug Cost (USD) : 86,574

Year : 2022

Prescribers : 71

Prescriptions : 586

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Medlab Asia & Asia Health
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Company :

Calcium Gluconate

Drug Cost (USD) : 84,407

Year : 2021

Prescribers : 62

Prescriptions : 580

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Medlab Asia & Asia Health
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Company :

Calcium Gluconate

Drug Cost (USD) : 41,454

Year : 2020

Prescribers : 53

Prescriptions : 463

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Medlab Asia & Asia Health
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Medlab Asia & Asia Health
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Company :

Calcium Gluconate

Drug Cost (USD) : 59,661

Year : 2019

Prescribers : 60

Prescriptions : 530

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Medlab Asia & Asia Health
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Medlab Asia & Asia Health
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Company :

Calcium Gluconate

Drug Cost (USD) : 25,355

Year : 2018

Prescribers : 58

Prescriptions : 175

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Medlab Asia & Asia Health
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Medlab Asia & Asia Health
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Company :

Calcium Gluconate

Drug Cost (USD) : 0

Year : 2017

Prescribers : 40

Prescriptions : 0

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Medlab Asia & Asia Health
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Medlab Asia & Asia Health
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Company :

Calcium Gluconate

Drug Cost (USD) : 0

Year : 2016

Prescribers : 54

Prescriptions : 0

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Medlab Asia & Asia Health
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Medlab Asia & Asia Health
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Company :

Calcium Gluconate

Drug Cost (USD) : 0

Year : 2015

Prescribers : 74

Prescriptions : 0

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09

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Medlab Asia & Asia Health
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Medlab Asia & Asia Health
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Company :

CALCIUM GLUCONATE

Drug Cost (USD) : 14,457

Year : 2014

Prescribers : 58

Prescriptions : 338

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Patents & EXCLUSIVITIES

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US Patents

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CALCIUM GLUCONATE

US Patent Number : 10130646

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 210906

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2037-07-25

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02

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Medlab Asia & Asia Health
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CALCIUM GLUCONATE

US Patent Number : 10130646

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 210906

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2037-07-25

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Medlab Asia & Asia Health
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CALCIUM GLUCONATE

US Patent Number : 10342813

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 210906

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2037-07-25

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Medlab Asia & Asia Health
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CALCIUM GLUCONATE

US Patent Number : 10342813

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 210906

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2037-07-25

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05

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Medlab Asia & Asia Health
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Medlab Asia & Asia Health
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CALCIUM GLUCONATE

US Patent Number : 10130646

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 210906

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2037-07-25

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06

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Medlab Asia & Asia Health
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Medlab Asia & Asia Health
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CALCIUM GLUCONATE

US Patent Number : 10342813

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 210906

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2037-07-25

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US Exclusivities

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Medlab Asia & Asia Health
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AMNEAL

U.S.A
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Medlab Asia & Asia Health
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CALCIUM GLUCONATE

Exclusivity Code : CGT

Exclusivity Expiration Date : 2024-03-10

Application Number : 217174

Product Number : 2

Exclusivity Details :

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02

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Medlab Asia & Asia Health
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AMNEAL

U.S.A
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Medlab Asia & Asia Health
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CALCIUM GLUCONATE

Exclusivity Code : CGT

Exclusivity Expiration Date : 2024-03-10

Application Number : 217174

Product Number : 1

Exclusivity Details :

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03

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Medlab Asia & Asia Health
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Medlab Asia & Asia Health
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CALCIUM GLUCONATE

Exclusivity Code : CGT

Exclusivity Expiration Date : 2024-04-30

Application Number : 216541

Product Number : 1

Exclusivity Details :

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SOMERSET

U.S.A
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Medlab Asia & Asia Health
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CALCIUM GLUCONATE

Exclusivity Code : CGT

Exclusivity Expiration Date : 2024-04-17

Application Number : 217689

Product Number : 1

Exclusivity Details :

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REF. STANDARDS & IMPURITIES

Upload your portfolio for free, ask us

EDQM

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EDQM, Council of Europe

Calcium gluconate

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Medlab Asia & Asia Health
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Calcium gluconate

CAS Number : 18016-24-5

Quantity Per Vial : 50 mg

Sale Unit : 1

Order Code : C0300000

Batch No : 3

Price (€) : 79

Storage : +5°C ± 3°C

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USP

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USP

U.S.A
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Medlab Asia & Asia Health
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USP

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Medlab Asia & Asia Health
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Others

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01

USP

U.S.A
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Medlab Asia & Asia Health
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USP

U.S.A
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Medlab Asia & Asia Health
Not Confirmed

Calcium Gluconate Anhydrous (200 mg)

CAS Number : 299-28-5

Quantity Per Vial : 200

Sale Unit : mg

Price : $245.00

Details : Material Origin- Chemical Synthesis; USMCA- N...

Monograph :

Storage :

Code/Batch No : Catalog #1086822 / R129A0

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02

USP

U.S.A
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Medlab Asia & Asia Health
Not Confirmed

USP

U.S.A
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Medlab Asia & Asia Health
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Calcium Gluconate Monohydrate (200 mg) (Calci...

CAS Number : 66905-23-5

Quantity Per Vial : 200

Sale Unit : mg

Price : $250.00

Details : Material Origin- Plant; USMCA- No; KORUS- No

Monograph :

Storage :

Code/Batch No : Catalog #1086833 / F0M413

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