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Chemistry

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Also known as: 22204-24-6, Pyrantel embonate, Antiminth, Combantrin, Pyrantel (pamoate), Cp-10,423-16
Molecular Formula
C34H30N2O6S
Molecular Weight
594.7  g/mol
InChI Key
AQXXZDYPVDOQEE-MXDQRGINSA-N
FDA UNII
81BK194Z5M

Pyrantel Pamoate
Broad spectrum antinematodal anthelmintic used also in veterinary medicine.
1 2D Structure

Pyrantel Pamoate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
4-[(3-carboxy-2-hydroxynaphthalen-1-yl)methyl]-3-hydroxynaphthalene-2-carboxylic acid;1-methyl-2-[(E)-2-thiophen-2-ylethenyl]-5,6-dihydro-4H-pyrimidine
2.1.2 InChI
InChI=1S/C23H16O6.C11H14N2S/c24-20-16(14-7-3-1-5-12(14)9-18(20)22(26)27)11-17-15-8-4-2-6-13(15)10-19(21(17)25)23(28)29;1-13-8-3-7-12-11(13)6-5-10-4-2-9-14-10/h1-10,24-25H,11H2,(H,26,27)(H,28,29);2,4-6,9H,3,7-8H2,1H3/b;6-5+
2.1.3 InChI Key
AQXXZDYPVDOQEE-MXDQRGINSA-N
2.1.4 Canonical SMILES
CN1CCCN=C1C=CC2=CC=CS2.C1=CC=C2C(=C1)C=C(C(=C2CC3=C(C(=CC4=CC=CC=C43)C(=O)O)O)O)C(=O)O
2.1.5 Isomeric SMILES
CN1CCCN=C1/C=C/C2=CC=CS2.C1=CC=C2C(=C1)C=C(C(=C2CC3=C(C(=CC4=CC=CC=C43)C(=O)O)O)O)C(=O)O
2.2 Other Identifiers
2.2.1 UNII
81BK194Z5M
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Antiminth

2. Combantrin

3. Embonate, Pyrantel

4. Embovin

5. Pamoate, Pyrantel

6. Pyrantel Embonate

2.3.2 Depositor-Supplied Synonyms

1. 22204-24-6

2. Pyrantel Embonate

3. Antiminth

4. Combantrin

5. Pyrantel (pamoate)

6. Cp-10,423-16

7. Pyrantel (as Pamoate)

8. Embovin

9. (e)-1,4,5,6-tetrahydro-1-methyl-2-(2-(2-thienyl)vinyl)pyrimidine 4,4'-methylenebis(3-hydroxy-2-naphthoate) (1:1)

10. Nsc-355080

11. Chebi:8655

12. Cp 10423-16

13. 81bk194z5m

14. Nsc355080

15. (e)-1-methyl-2-(2-(thiophen-2-yl)vinyl)-1,4,5,6-tetrahydropyrimidine 4,4'-methylenebis(3-hydroxy-2-naphthoate)

16. Cp-10423-16

17. Cp-10423-18

18. Pyrimidine, 1,4,5,6-tetrahydro-1-methyl-2-(2-(2-thienyl)ethenyl)-, (e)-, Compd. With 4,4'-methylenebis(3-hydroxy-2-naphthalenecarboxylic Acid) (1:1)

19. Cobantril

20. Sentry Hc Worm X

21. 2-naphthalenecarboxylic Acid, 4,4'-methylenebis[3-hydroxy-, Compd. With 1,4,5,6-tetrahydro-1-methyl-2-[(1e)-2-(2-thienyl)ethenyl]pyrimidine (1:1)

22. 4-[(3-carboxy-2-hydroxy-1-naphthyl)methyl]-3-hydroxy-naphthalene-2-carboxylic Acid; 1-methyl-2-[(e)-2-(2-thienyl)vinyl]-5,6-dihydro-4h-pyrimidine

23. 4-[(3-carboxy-2-hydroxynaphthalen-1-yl)methyl]-3-hydroxynaphthalene-2-carboxylic Acid;1-methyl-2-[(e)-2-thiophen-2-ylethenyl]-5,6-dihydro-4h-pyrimidine

24. Sentry Hc Worm X Ds

25. Einecs 244-837-1

26. Vetscription Sure Shot 2x

27. Nsc 355080

28. Pyirantelpamoate

29. Unii-81bk194z5m

30. Pyrantel Pamoates

31. Pyranteli Embonas

32. Antiminth (tn)

33. Pyrantel Pamoate [usan:usp:jan]

34. 2-naphthalenecarboxylic Acid, 4,4'-methylenebis(3-hydroxy-, Compd. With 1,4,5,6-tetrahydro-1-methyl-2-((1e)-2-(2-thienyl)ethenyl)pyrimidine (1:1)

35. Spectrum5_001373

36. Pyrantel Pamoate, Bioxtra

37. (3-hydroxy-2-naphthoate)

38. Schembl41025

39. 2-naphthalenecarboxylic Acid, 4,4'-methylenebis(3-hydroxy-, Compd. With (e)-1,4,5,6-tetrahydro-1-methyl-2-(2-(2-thienyl)ethenyl)pyrimidine (1:1)

40. Pyrantel Pamoate [mi]

41. Spectrum1500517

42. Pyrantel Pamoate [jan]

43. Pyrantel Pamoate (jp17/usp)

44. Schembl7793068

45. Pyrantel Pamoate [usan]

46. Chembl1599768

47. Pyrantel Pamoate [vandf]

48. Hms500m16

49. Pyrantel Pamoate Sigmaultra,(s)

50. Amy3564

51. Dtxsid40897057

52. Pyrantel Embonate [mart.]

53. Pyrantel Pamoate [usp-rs]

54. Hms1920n06

55. Hms2090j21

56. Hms2092e07

57. Pharmakon1600-01500517

58. Pyrantel Embonate [who-dd]

59. Pyrantel Embonate [who-ip]

60. Ccg-39242

61. Mfcd00072037

62. Nsc757303

63. S2501

64. Stl481883

65. Pyrantel Pamoate [green Book]

66. Akos015908224

67. Cs-3869

68. Nsc-757303

69. Idi1_000254

70. Pyrantel Embonate [ep Monograph]

71. Pyrantel Pamoate [usp Monograph]

72. Ncgc00094552-01

73. Ncgc00094552-02

74. Ncgc00094552-03

75. Pyranteli Embonas [who-ip Latin]

76. 2-naphthoic Acid, 4,4'-methylenebis(3-hydroxy-, Compd. With (e)-1,4,5,6-tetrahydro-1-methyl-2-(2-(2-thienyl)vinyl)pyrimidine (1:1)

77. 4,4'-methylenebis(3-hydroxy-2-naphthoic) Acid, Compound With (e)-1,4,5,6-tetrahydro-1-methyl-2-(2-(2-thienyl)vinyl)pyrimidine (1:1)

78. Ac-24204

79. As-12185

80. Bp166202

81. Hy-12640

82. Sbi-0051499.p003

83. C07389

84. D00486

85. F21340

86. 204p246

87. A816013

88. Sr-05000001708

89. Q3489331

90. Sr-05000001708-1

91. Pyrantel Pamoate, Vetranal(tm), Analytical Standard

92. (e)-1-methyl-2-(2-(thiophen-2-yl)vinyl)-1,4,5,6

93. Pyrantel Embonate, European Pharmacopoeia (ep) Reference Standard

94. Pyrantel Pamoate, United States Pharmacopeia (usp) Reference Standard

95. Pyrimidine,1,4,5,6-tetrahydro-1-methyl-2-[(1e)-2-(2-thienyl)ethenyl]-

96. (e)-1,5,6-tetrahydro-1-methyl-2-[2-(2-thienyl)vinyl]pyrimidine 4,4'-methylenebis[3-hydroxy-2-naphthoate] (1:1)

97. 2-naphthalenecarboxylic Acid,4'-methylenebis[3-hydroxy-, Compd. With (e)-1,4,5,6-tetrahydro-1-methyl-2-[2-(2-thienyl)ethenyl]pyrimidine (1:1)

98. 2-naphthoic Acid,4'-methylenebis[3-hydroxy-, Compd. With (e)-1,4,5,6-tetrahydro-1-methyl-2-[2-(2-thienyl)vinyl]pyrimidine (1:1)

99. 4,4'-methanediylbis(3-hydroxynaphthalene-2-carboxylic Acid) - 1-methyl-2-[(e)-2-(thiophen-2-yl)ethenyl]-1,4,5,6-tetrahydropyrimidine (1:1)

100. 4-[(3-carboxy-2-hydroxynaphthalen-1-yl)methyl]-3-hydroxynaphthalene-2-carboxylic Acid,1-methyl-2-[(e)-2-thiophen-2-ylethenyl]-5,6-dihydro-4h-pyrimidine

101. Pyrimidine, 1,4,5,6-tetrahydro-1-methyl-2-[2-(-2-thienyl)ethenyl-, (e)-, With 4,4'-methylenebis[3-hydroxy-2-naphthalenecarboxylic Acid (1:1)

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 594.7 g/mol
Molecular Formula C34H30N2O6S
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count8
Rotatable Bond Count6
Exact Mass594.18245785 g/mol
Monoisotopic Mass594.18245785 g/mol
Topological Polar Surface Area159 Ų
Heavy Atom Count43
Formal Charge0
Complexity816
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Antinematodal Agents

Substances used in the treatment or control of nematode infestations. They are used also in veterinary practice. (See all compounds classified as Antinematodal Agents.)


API SUPPLIERS

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LGM Pharma

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Moehs Iberica

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Cosma (C.F.M. Group)

Italy

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UQUIFA

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Cosma Spa

Italy
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DMF Number : 7669

Submission : 1988-09-09

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Ipca Laboratories Ltd

India

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Olon Spa

Italy

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Olon Spa

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Uquifa Italia Spa

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Certificate Number : CEP 2005-294 - Rev 03

Status : Valid

Issue Date : 2025-02-25

Type : Chemical

Substance Number : 1680

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Certificate Number : R1-CEP 2006-162 - Rev 02

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Pyrantel pamoate (for manufacturing purposes only)

Registration Number : 221MF10046

Registrant's Address : Sethna 4th floor 55 Maharshi karve road Marine Lines,Mumbai-400002,INDIA

Initial Date of Registration : 2009-02-25

Latest Date of Registration : 2018-10-12

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LGM Pharma

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About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulation, analytical method development and testing, custom API synthesis, regulatory support, and commercial manufacturing. Supported by a network of over 300 accredited cGMP manufacturing partners and more than 100,000 sq. ft. of FDA-inspected cGMP manufacturing and warehouse space, LGM delivers secure, end-to-end solutions across multiple dosage forms. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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Pyrantel Pamoate

About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...

Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and regulatory support, and strives for global standards. Known for quality and affordability, it has established a niche through innovative methods and exports to nearly every continent. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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Pyrantel Embonate

About the Company : Since 1962, MOEHS has produced high-quality Active Pharmaceutical Ingredients (APIs) for the global market. With decades of technical expertise, Moehs Group delivers pharmaceutical...

Since 1962, MOEHS has produced high-quality Active Pharmaceutical Ingredients (APIs) for the global market. With decades of technical expertise, Moehs Group delivers pharmaceutical, veterinary, agrochemical, nutraceutical, cosmetic, and fine chemical products. Our facilities meet the highest standards, including GMP, ICH, FDA, and TGA approvals, ensuring reliable and safe manufacturing. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only.
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About the Company : Established in 1991, Pharm-Rx is an importer and distributor of active ingredients serving the pharmaceutical, nutritional supplement, and food industries. The company follows a hi...

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Pyrantel Pamoate

About the Company : Cosma S.p.A., part of the CFM Group with AMSA and Clarochem Ireland, is the group’s largest manufacturing site in Bergamo, Italy. With 130,000L glass-lined reaction volume and ov...

Cosma S.p.A., part of the CFM Group with AMSA and Clarochem Ireland, is the group’s largest manufacturing site in Bergamo, Italy. With 130,000L glass-lined reaction volume and over 300 tons annual API output, Cosma exports more than half its production to the U.S. and serves leading global pharma and animal health companies. AMSA specializes in small- to medium-volume APIs, while Clarochem Ireland offers 60,000L contract manufacturing capacity, ensuring global scale, quality, and reliability. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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Pyrantel Pamoate

About the Company : Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 s...

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Pyrantel Pamoate

About the Company : Daishang Chemical Co., Ltd. established in January 2005, sticking to the guiding principle "Technical innovation, Quality Orientation", we practice best of technology innovation, o...

Daishang Chemical Co., Ltd. established in January 2005, sticking to the guiding principle "Technical innovation, Quality Orientation", we practice best of technology innovation, optimized management and robust service system for our customers. Daishang Chem is specialized in the researching, manufacturing, sales and marketing of API & Its Intermediates as well as other Fine Chemicals, taking great advantages of professional and proficient staff, based on three chemical manufacturing sites and one GMP manufacturing workshops in Liaoning, Henan and Zhejiang provinces, and one R&D laboratory in Zhangjiang Hi-tech Park.
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Pyrantel Pamoate

About the Company : Ipca Laboratories, headquartered in Mumbai, India, is a prominent pharmaceutical enterprise established in 1949. Over the years, Ipca has emerged as a leading player in India's pha...

Ipca Laboratories, headquartered in Mumbai, India, is a prominent pharmaceutical enterprise established in 1949. Over the years, Ipca has emerged as a leading player in India's pharmaceutical landscape, specializing in the manufacturing and commercialization of a diverse range of healthcare products, including APIs, formulations, and generic drugs. Renowned for its exceptional research and development capabilities, Ipca is dedicated to delivering high-quality and cost-effective medications across various therapeutic domains, including anti-malarial, anti-infective, anti-inflammatory, cardiovascular, central nervous system, among others.
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JRC

India
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JRC

India
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Pyrantel Pamoate

About the Company : We commit to be a customer focused business and acknowledge that to be successful we have to make the opportunity offered by our clients work for them and for the future prosperity...

We commit to be a customer focused business and acknowledge that to be successful we have to make the opportunity offered by our clients work for them and for the future prosperity of JRC. The opportunity within JRC is to promote an open environment to explore knowledge, share thoughts in a transparent manner and maintain our commitments to all the stakeholders at large. JRC’s strength over 5 years is in science and technology that includes synthetic organic chemistry, process research, and scale-up from laboratory to commercial-scale along with quality and regulatory support.
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UQUIFA

Spain
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UQUIFA

Spain
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Pyrantel Pamoate

About the Company : With over 85 years of experience, Uquifa provides comprehensive services supporting projects from proof of concept to commercial manufacturing. Uquifa’s business model is built o...

With over 85 years of experience, Uquifa provides comprehensive services supporting projects from proof of concept to commercial manufacturing. Uquifa’s business model is built on a quality manufacturing platform and a strong track record of service and reliability. Uquifa Group manufactures Active Pharmaceutical Ingredients (APIs) and intermediates for the global pharmaceutical and animal health industries.
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B5 (pt) & B6 (pt) SIPCOT INDUSTRIAL PARK, IRUNGATTUKOTTAI","city":"SRIPERUMBUDUR","supplier":"UQUIFA MEXICO","supplierCountry":"MEXICO","foreign_port":"MEXICO CITY","customer":"ORBION PHARMACEUTICALS PRIVATE LTD","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"80","totalValueFC":"8085.5","currency":"USD","unitRateINR":"6752","date":"25-Apr-2024","totalValueINR":"675200","totalValueInUsd":"8085.5","indian_port":"Madras Air","hs_no":"29349990","bill_no":"3191598","productDescription":"API","marketType":"","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"MEXICO CITY","supplierAddress":"CALLE 37 ESTE 126, CIVAC JIUTEPECJIUTEPEC MORELOS 62578SDNF MX","customerAddress":"PLOT NOS. B5 (pt) & B6 (pt) SIPCOT INDUSTRIAL PARK, IRUNGATTUKOTTAI"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1727980200,"product":"PYRANTEL PAMOATE - LOT NO:1018245005","address":"PLOT NOS. 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B5 (pt) & B6 (pt) SIPCOT INDUSTRIAL PARK, IRUNGATTUKOTTAI"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1751049000,"product":"PYRANTEL PAMOATE","address":"ZYDUS CORPORATE PARK, SCHEME NO. 63, SURVEY NO. 536","city":"AHMEDABAD","supplier":"COPRIMA S L","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"ZYDUS ANIMAL HEALTH AND INVESTMENTS LTD","customerCountry":"INDIA","quantity":"60.00","actualQuantity":"60","unit":"KGS","unitRateFc":"140","totalValueFC":"8568.6","currency":"USD","unitRateINR":"12271","date":"28-Jun-2025","totalValueINR":"736260","totalValueInUsd":"8568.6","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29349990","bill_no":"2937810","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"PABLO PICASSO 15 08213 POLINYA, BARCELONA SDNF Spain","customerAddress":"ZYDUS CORPORATE PARK, SCHEME NO. 63, SURVEY NO. 536"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1752690600,"product":"PYRANTEL PAMOATE - 1018255008 PYRANTEL PAMOATE - 1018255008","address":"PLOT NOS. 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DT. 29\/10\/2024 EXP. DT. 10\/2029PYRANTEL PAMOATE. B\/N: 71-MC. MFG. DT. 29\/10\/2024 EXP. DT. 1","address":"SUR. NO. 377\/1B, BS. UDHYAN BUNGLO","city":"AHMEDABAD,GUJARAT","supplier":"COPRIMA SL","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"XYLOPIA LABS PRIVATE LTD","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"140","totalValueFC":"2777","currency":"USD","unitRateINR":"12152","date":"02-Aug-2025","totalValueINR":"243040","totalValueInUsd":"2777","indian_port":"Ahmedabad Air","hs_no":"29349990","bill_no":"3657637","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"C\/PABLO PICASSO 15, 08213 POLINYA , BARCELONA SDNF SPAIN","customerAddress":"SUR. NO. 377\/1B, BS. UDHYAN BUNGLO"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1764181800,"product":"PYRANTEL PAMOATE","address":"ZYDUS CORPORATE PARK, SCHEME NO. 63, SURVEY NO. 536","city":"AHMEDABAD","supplier":"COPRIMA S L","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"ZYDUS ANIMAL HEALTH AND INVESTMENTS LTD","customerCountry":"INDIA","quantity":"60.00","actualQuantity":"60","unit":"KGS","unitRateFc":"140","totalValueFC":"8458.5","currency":"USD","unitRateINR":"12530","date":"27-Nov-2025","totalValueINR":"751800","totalValueInUsd":"8458.5","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29349990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"PABLO PICASSO 15 08213 POLINYA, BARCELONA SDNF Spain","customerAddress":"ZYDUS CORPORATE PARK, SCHEME NO. 63, SURVEY NO. 536"}]
07-Jan-2022
27-Nov-2025
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ABOUT THIS PAGE

Looking for 22204-24-6 / Pyrantel Pamoate API manufacturers, exporters & distributors?

Pyrantel Pamoate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Pyrantel Pamoate 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 Pyrantel Pamoate manufacturer or Pyrantel Pamoate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pyrantel Pamoate manufacturer or Pyrantel Pamoate supplier.

PharmaCompass also assists you with knowing the Pyrantel Pamoate API Price utilized in the formulation of products. Pyrantel Pamoate API Price is not always fixed or binding as the Pyrantel Pamoate Price is obtained through a variety of data sources. The Pyrantel Pamoate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Pyrantel Pamoate

Synonyms

22204-24-6, Pyrantel embonate, Antiminth, Combantrin, Pyrantel (pamoate), Cp-10,423-16

Cas Number

22204-24-6

Unique Ingredient Identifier (UNII)

81BK194Z5M

About Pyrantel Pamoate

Broad spectrum antinematodal anthelmintic used also in veterinary medicine.

Helmex Manufacturers

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

Helmex Suppliers

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

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

Helmex USDMF

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

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

click here to find a list of Helmex suppliers with USDMF on PharmaCompass.

Helmex JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

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

Helmex CEP

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

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

Helmex WC

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

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

Helmex NDC

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 Helmex as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Helmex API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Helmex 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Helmex and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Helmex NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Helmex suppliers with NDC on PharmaCompass.

Helmex GMP

Helmex 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 Helmex 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 Helmex GMP manufacturer or Helmex GMP API supplier for your needs.

Helmex CoA

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

Helmex CoA mostly includes findings from lab analyses of a specific batch. For each Helmex 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.

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

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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