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10 API Suppliers, 1 USDMF, 9 Listed Suppliers, $ API Reference Price

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91 FDF Dossiers
22 FDA Orange Book
6 Europe
32 Canada
7 South Africa
24 Listed Dossiers

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7 SPI Pharma, 10 DKSH, 2 Jai Radhe Sales, 12 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 BASF, 10 Corel Pharma Chem, 3 DFE Pharma, 3 Finar, 10 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 16 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 24 Roquette, 13 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 2 The Dow Chemical Company, 3 Vasa Pharmachem

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Synopsis

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Chemistry

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Also known as: Zinc sulphate, 7733-02-0, Zinc sulfate anhydrous, Zincate, Zinc sulfate (1:1), Znso4

Molecular Formula

O₄SZn

Molecular Weight

161.4 g/mol

InChI Key

NWONKYPBYAMBJT-UHFFFAOYSA-L

FDA UNII

0J6Z13X3WO

A compound given in the treatment of conditions associated with zinc deficiency such as acrodermatitis enteropathica. Externally, zinc sulfate is used as an astringent in lotions and eye drops. (Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995)

1 2D Structure

Zinc Sulphate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

zinc;sulfate

2.1.2 InChI

InChI=1S/H2O4S.Zn/c1-5(2,3)4;/h(H2,1,2,3,4);/q;+2/p-2

2.1.3 InChI Key

NWONKYPBYAMBJT-UHFFFAOYSA-L

2.1.4 Canonical SMILES

[O-]S(=O)(=O)[O-].[Zn+2]

2.2 Other Identifiers

2.2.1 UNII

0J6Z13X3WO

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Sulfate, Zinc

2. Zinc Sulfate, Heptahydrate

3. Zincteral

2.3.2 Depositor-Supplied Synonyms

1. Zinc Sulphate

2. 7733-02-0

3. Zinc Sulfate Anhydrous

4. Zincate

5. Zinc Sulfate (1:1)

6. Znso4

7. Sulfuric Acid, Zinc Salt (1:1)

8. Sulfate De Zinc

9. Zinc(ii) Sulfate

10. Zinc Sulphate Anhydrous

11. Zinc Sulfate, Anhydrous

12. Zinc Sulphate, Anhydrous

13. Zinc Sulfate (anhydrous)

14. Zinc Sulfate Hydrate

15. 0j6z13x3wo

16. Chebi:35176

17. Nsc-32677

18. Nsc-135806

19. Complexonat

20. Medizinc

21. Optised

22. Orazinc

23. Solvezinc

24. Zinklet

25. Neozin

26. Visine-ac

27. Zinci Sulfas

28. Prefrin-z

29. Zincum Sulfuricum

30. Zink-gro

31. Zinc Sulfate Solution

32. Zinc Vitriol (van)

33. Caswell No. 927

34. White Vitriol (van)

35. Zincsulphate

36. Salvazinc

37. Zinc;sulfate

38. Nu-z

39. Sulfuric Acid, Zinc Salt

40. Zinc-200

41. Sulfate De Zinc [french]

42. Ccris 3664

43. Sulfuric Acid Zinc Salt (van)

44. Hsdb 1063

45. Einecs 231-793-3

46. Nsc 32677

47. Epa Pesticide Chemical Code 089001

48. Nsc 135806

49. Unii-0j6z13x3wo

50. Ai3-03967

51. Sulfato De Cinc

52. Zinc(ii)sulfate

53. Sulfato De Zinco

54. Solfato Di Zinco

55. Zinc (as Sulfate)

56. Zinc(2+) Sulfate

57. Mfcd00011302

58. Zinc (as Sulphate)

59. Zinc Sulphate Hydrate

60. Zinci Sulfas Monohydrate

61. Zinc Suflate Monohydrate

62. Zinc Sulfate, Unspecified

63. Zinc Sulfate [mi]

64. Zinc Sulphate Nanoparticles

65. Ec 231-793-3

66. Zinc Sulfate [hsdb]

67. Zinc Sulfate, Unspecified Form

68. Chembl1200929

69. Dtxsid2040315

70. Akos025295737

71. Zinc Sulfate, 100mm Aqueous Solution

72. Db09322

73. Q204954

74. J-010404

2.4 Create Date

2004-09-16

3 Chemical and Physical Properties

Molecular Formula	O₄SZn
Molecular Weight	161.4 g/mol
Hydrogen Bond Donor Count	0
Hydrogen Bond Acceptor Count	4
Rotatable Bond Count	0
Exact Mass	159.880871 g/mol
Monoisotopic Mass	159.880871 g/mol
Topological Polar Surface Area	88.6 Å²
Heavy Atom Count	6
Formal Charge	0
Complexity	62.2
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Therapeutic Uses

Mesh Heading: Astringent

National Library of Medicine, SIS; ChemIDplus Record for Zinc Sulfate. (7733-02-0). Available from, as of April 17, 2006: https://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp

Dietary supplement ingredient in use before October 15, 1994 (Mineral and trace element) /Date of the Dietary Supplement Health and Education Act of 1994/..

NNFA List of Dietary Supplement Ingredients In Use Before October 15, 1994. Available from, as of December 8, 2006: https://www.fda.gov/ohrms/dockets/dockets/05p0305/05p-0305-cr00001-03-NNFA-List-vol1.pdf

MEDICATION (VET): Zinc sulfate, USP, applied topically in 10% aqueous solution, is highly effective in treatment of foot rot in sheep.

Booth, N.H., L.E. McDonald (eds.). Veterinary Pharmacology and Therapeutics. 5th ed. Ames, Iowa: Iowa State University Press, 1982., p. 670

MEDICATION (VET): Useful antiseptic astringent for ophthalmic use as aqueous solution or ointment (0.25-0.5%). Spraying sheep with 0.25% solution after shearing reduced incidence of infected wounds. 1% solutions have been used on granular vaginitis lesions of cows, posthitis of rams, and make excellent detergent, odorless, antiseptic egg wash. ... As white lotion ... on bruised, inflamed, pruritic skin areas on cows and horses.

Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 669

For more Therapeutic Uses (Complete) data for ZINC SULFATE (26 total), please visit the HSDB record page.

4.2 Drug Warning

... Zinc sulfate often is an effective /emetic/, but potential hemolytic and renal toxicity is too great to recommend use ... .

American Medical Association, AMA Department of Drugs. AMA Drug Evaluations. 5th ed. Chicago: American Medical Association, 1983., p. 489

Thiazide diuretics have been found to increase urinary zinc excretion. /Zinc supplements/

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.

Large doses of zinc may inhibit copper absorption in the intestine; zinc supplements should be taken at least 2 hours after the administration of copper supplements. /Zinc supplements/

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.

Patients using zinc sulfate ophthalmic solutions should be advised to discontinue the drug and consult a physician if ocular pain or visual changes occur, they experience continued ocular redness or irritation, or the condition worsens or persists for more than 3 days.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 2761

For more Drug Warnings (Complete) data for ZINC SULFATE (15 total), please visit the HSDB record page.

4.3 Drug Indication

This medication is a mineral used to treat or prevent low levels of zinc alone and together with oral rehydration therapy (ORT). It is also used as a topical astringent. Zinc Sulfate Injection, USP is indicated for use as a supplement to intravenous solutions given for TPN.

Zinc sulfate is a common zinc supplement in parenteral nutrition.

5 Pharmacology and Biochemistry

5.1 Pharmacology

Zinc has been identified as a cofactor for over 70 different enzymes, including alkaline phosphatase, lactic dehydrogenase and both RNA and DNA polymerase. Zinc facilitates wound healing, helps maintain normal growth rates, normal skin hydration and the senses of taste and smell.

5.2 MeSH Pharmacological Classification

Astringents

Agents, usually topical, that cause the contraction of tissues for the control of bleeding or secretions. (See all compounds classified as Astringents.)

5.3 FDA Pharmacological Classification

5.3.1 Pharmacological Classes

Decreased Copper Ion Absorption [PE]; Copper Absorption Inhibitor [EPC]

5.4 ATC Code

A - Alimentary tract and metabolism

A12 - Mineral supplements

A12C - Other mineral supplements

A12CB - Zinc

A12CB01 - Zinc sulfate

B - Blood and blood forming organs

B05 - Blood substitutes and perfusion solutions

B05X - I.v. solution additives

B05XA - Electrolyte solutions

B05XA18 - Zinc sulfate

5.5 Absorption, Distribution and Excretion

Absorption

Approximately 20 to 30% of dietary zinc is absorbed, primarily from the duodenum and ileum. The amount absorbed is dependent on the bioavailability from food. Zinc is the most bioavailable from red meat and oysters. Phytates may impair absorption by chelation and formation of insoluble complexes at an alkaline pH. After absorption, zinc is bound in the intestine to the protein metallothionein. Endogenous zinc can be reabsorbed in the ileum and colon, creating an enteropancreatic circulation of zinc.

Route of Elimination

Primarily fecal (approximately 90%); to a lesser extent in the urine and in perspiration.

Volume of Distribution

After absorption zinc is bound to protein metallothionein in the intestines. Zinc is widely distributed throughout the body. It is primarily stored in RBCs, WBCs, muscles, bones, Skin, Kidneys, Liver, Pancreas, retina, and prostate.

The pharmacokinetics of zinc sulfate were compared with those of a new zinc pantothenate, in rabbits. Each salt was administered to rabbits at a dosage of 3.3 uCi of zinc-65/kg of body weight. The measured pharmacokinetics of the two compounds responded to a two compartment open model. The urinary elimination of the two salts was similar, as was their localization in the skin and fur, but Zn pantothenate was retained by the liver to a lesser extent than was zinc sulfate (ZnSO4).

PMID:6520772 Guillard O et al; J Pharm Sci 73 (11): 1642-3 (1984)

Absorption: 20% to 30%. Protein binding: 99%. Elimination: Through small bowel excretion.

Lelkin, J.B., Paloucek, F.P., Poisoning & Toxicology Compendium. LEXI-COMP Inc. & American Pharmaceutical Association, Hudson, OH 1998., p. 573

In women in different trimesters of pregnancy, the oral administration of 200 mg zinc sulfate per day resulted in an increase of serum zinc levels from 109.7 to 205.4 mg/dL. In the control group, serum zinc levels declined from 113.0 mg/dL in the first trimester to 83.8 in the third trimester.

Bingham, E.; Cohrssen, B.; Powell, C.H.; Patty's Toxicology Volumes 1-9 5th ed. John Wiley & Sons. New York, N.Y. (2001)., p. 2:267

...An absorption half-life of 0.4 hr /was reported/ when 45 mg Zn2+ as zinc sulfate was administered once in gelatine capsules to 10 healthy young men. Serum concentrations were measured frequently during a total investigation time of 8 hours. A mean maximum concentration of 8.2 umol Zn2+/L serum was found after 2.3 hours (tmax). There is evidence of an enteral recirculation, the first rebound effect appeared after 1.4 hours during the absorption phase before tmax was reached, and exhibited mean reabsorption rates of 70% of the dose given. The subsequent ones (max. of 5) appeared at regular intervals of 1.2 hours with a decrease of the quantity reabsorbed.

European Chemicals Bureau; EU Risk Assessment Report- Zinc sulphate, Vol.46 p.31 (2004). Available from, as of June 29, 2006: https://esis.jrc.ec.europa.eu/

For more Absorption, Distribution and Excretion (Complete) data for ZINC SULFATE (14 total), please visit the HSDB record page.

5.6 Biological Half-Life

3 hours

Half-life: 3 hours

Lelkin, J.B., Paloucek, F.P., Poisoning & Toxicology Compendium. LEXI-COMP Inc. & American Pharmaceutical Association, Hudson, OH 1998., p. 573

5.7 Mechanism of Action

Zinc inhibits cAMP-induced, chloride-dependent fluid secretion by inhibiting basolateral potassium (K) channels, in in-vitro studies with rat ileum. This study has also shown the specificity of Zn to cAMP-activated K channels, because zinc did not block the calcium (Ca)-mediated K channels. As this study was not performed in Zn-deficient animals, it provides evidence that Zn is probably effective in the absence of Zn deficiency. Zinc also improves the absorption of water and electrolytes, improves regeneration of the intestinal epithelium, increases the levels of brush border enzymes, and enhances the immune response, allowing for a better clearance of the pathogens.

API SUPPLIERS

01

Biophore India Pharmaceuticals Pvt...

India

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Zinc Sulfate Heptahydrate Usp

GDUFA

DMF Review : Complete

Rev. Date : 2022-07-01

Pay. Date : 2022-06-24

DMF Number : 36963

Submission : 2022-03-31

Status : Active

Type : II

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AP","supplier":"SPANSULES PHARMA","supplierCountry":"INDIA","foreign_port":"BEIRUT","customer":"BAIT ALDAWAA DRUG ","customerCountry":"LEBANON","quantity":"3000.00","actualQuantity":"3000","unit":"KGS","unitRateFc":"8","totalValueFC":"23711.1","currency":"USD","unitRateINR":660.01666666666665,"date":"16-Apr-2024","totalValueINR":"1980050","totalValueInUsd":"23711.1","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"9175072","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"LEBANON","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.163, SUBHASH NAGAR,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715625000,"product":"CARBONYL IRON 50MG + FOLIC ACID 0.6MG +ZINC SULPHATE MONOHYDRATE 61.8MG BLEND PELLETS (PHARMACEUTICAL RAW MATERIAL)","address":"5-9-264\/2, RAJEEV GANDHI NAGAR","city":"HYDERABAD.AP","supplier":"M. R. LABORATORIES PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"SHAHJALAL ISLAMI BANK ","customerCountry":"BANGLADESH","quantity":"1500.00","actualQuantity":"1500","unit":"KGS","unitRateFc":"6","totalValueFC":"5945.7","currency":"USD","unitRateINR":330.39999999999998,"date":"14-May-2024","totalValueINR":"495600","totalValueInUsd":"5945.7","indian_port":"Hyderabad Air","hs_no":"29362290","bill_no":"9867273","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pellets","supplierPort":"Hyderabad Air","supplierAddress":"5-9-264\/2, RAJEEV GANDHI NAGAR, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720463400,"product":"BLENDED PELLETS CARBONYL IRON, ZINC SULPHATE MH & FOLIC ACID BATCH NO. PC\/CZF\/05\/24\/001 MFG.APR-24. EXP.MAR-26","address":"SCO-86, SECOND FLOOR,SECTOR-38C","city":"CHANDIGARH,CHANDIGARH","supplier":"CARESWORTH INTERNATIONAL","supplierCountry":"INDIA","foreign_port":"BEIRUT","customer":"ABDULHAMID SALAH OMLEH DRUG STORE","customerCountry":"LEBANON","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"6","totalValueFC":"2967.1","currency":"USD","unitRateINR":496.05374,"date":"09-Jul-2024","totalValueINR":"248026.87","totalValueInUsd":"2967.1","indian_port":"Delhi Air","hs_no":"29339990","bill_no":"2278541","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"LEBANON","selfForZScoreResived":"Pellets","supplierPort":"Delhi Air","supplierAddress":"SCO-86, SECOND FLOOR,SECTOR-38C, CHANDIGARH,CHANDIGARH","customerAddress":""}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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ACTIVE PHARMA INGREDIENTS

10 API Suppliers

1 USDMF

9 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

91 FDF Dossiers

22 FDA Orange Book

6 Europe

32 Canada

7 South Africa

24 Listed Dossiers

RELATED EXCIPIENT COMPANIES

7 SPI Pharma

10 DKSH

2 Jai Radhe Sales

12 Gangwal Healthcare

3 Nanjing Well Pharmaceutical

4 ACG Worldwide

9 Actylis

1 Aeon Procare

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

3 BASF

10 Corel Pharma Chem

3 DFE Pharma

3 Finar

10 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

3 Ingredion Pharma Solutions

16 Kerry

3 Kima Chemical

6 Lonza Capsugel

12 Microlex e.U

1 Nanjing Bold Chemical

1 Novo Excipients

1 Pharmatrans-Sanaq

5 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

24 Roquette

13 Seppic

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

9 Sigachi Industries

2 The Dow Chemical Company

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

48 Fillers, Diluents & Binders

46 Coating Systems & Additives

28 Direct Compression

28 Thickeners and Stabilizers

23 Solubilizers

22 Controlled & Modified Release

19 Disintegrants & Superdisintegrants

17 Parenteral

15 Taste Masking

14 Lubricants & Glidants

13 Co-Processed Excipients

12 Film Formers & Plasticizers

11 Granulation

9 Empty Capsules

8 Emulsifying Agents

8 Chewable & Orodispersible Aids

6 Topical

5 API Stability Enhancers

4 Coloring Agents

4 Rheology Modifiers

4 Vegetarian Capsules

2 Surfactant & Foaming Agents

DIGITAL CONTENT

11 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 Finished Drug Prices