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Chemistry

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Also known as: Clomiphene citrate, 50-41-9, Zuclomiphene citrate, Cis-clomiphene citrate, Clomid, Zuclomid
Molecular Formula
C32H36ClNO8
Molecular Weight
598.1  g/mol
InChI Key
PYTMYKVIJXPNBD-OQKDUQJOSA-N
FDA UNII
UY5X264QZV

Clomiphene Citrate
A triphenyl ethylene stilbene derivative which is an estrogen agonist or antagonist depending on the target tissue. Note that ENCLOMIPHENE and ZUCLOMIPHENE are the (E) and (Z) isomers of Clomiphene respectively.
1 2D Structure

Clomiphene Citrate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[4-[(Z)-2-chloro-1,2-diphenylethenyl]phenoxy]-N,N-diethylethanamine;2-hydroxypropane-1,2,3-tricarboxylic acid
2.1.2 InChI
InChI=1S/C26H28ClNO.C6H8O7/c1-3-28(4-2)19-20-29-24-17-15-22(16-18-24)25(21-11-7-5-8-12-21)26(27)23-13-9-6-10-14-23;7-3(8)1-6(13,5(11)12)2-4(9)10/h5-18H,3-4,19-20H2,1-2H3;13H,1-2H2,(H,7,8)(H,9,10)(H,11,12)/b26-25-;
2.1.3 InChI Key
PYTMYKVIJXPNBD-OQKDUQJOSA-N
2.1.4 Canonical SMILES
CCN(CC)CCOC1=CC=C(C=C1)C(=C(C2=CC=CC=C2)Cl)C3=CC=CC=C3.C(C(=O)O)C(CC(=O)O)(C(=O)O)O
2.1.5 Isomeric SMILES
CCN(CC)CCOC1=CC=C(C=C1)/C(=C(/C2=CC=CC=C2)\Cl)/C3=CC=CC=C3.C(C(=O)O)C(CC(=O)O)(C(=O)O)O
2.2 Other Identifiers
2.2.1 UNII
UY5X264QZV
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Chloramiphene

2. Citrate, Clomiphene

3. Clomid

4. Clomide

5. Clomifen

6. Clomifene

7. Clomiphene

8. Clomiphene Citrate

9. Clomiphene Hydrochloride

10. Clostilbegit

11. Dyneric

12. Gravosan

13. Hydrochloride, Clomiphene

14. Klostilbegit

15. Serophene

2.3.2 Depositor-Supplied Synonyms

1. Clomiphene Citrate

2. 50-41-9

3. Zuclomiphene Citrate

4. Cis-clomiphene Citrate

5. Clomid

6. Zuclomid

7. Clomiphene A Citrate

8. 7619-53-6

9. Clomiphene Citrate Salt

10. Milophene

11. Serophene

12. (z)-clomiphene Citrate

13. Chloramiphene

14. Omifin

15. Rmi 16289

16. Clomivid

17. Clomphid

18. Dyneric

19. Genozym

20. Ikaclomin

21. Clomifene Citrate (serophene)

22. Zuclomiphene (citrate)

23. Uy5x264qzv

24. Mrl 41

25. Nsc-151466

26. 2-(4-(2-chloro-1,2-diphenylvinyl)phenoxy)-n,n-diethylethanamine 2-hydroxypropane-1,2,3-tricarboxylate

27. Nsc 35770

28. Rmi 16312

29. 2-[4-[(z)-2-chloro-1,2-diphenylethenyl]phenoxy]-n,n-diethylethanamine;2-hydroxypropane-1,2,3-tricarboxylic Acid

30. Ethanamine, 2-(4-((1z)-2-chloro-1,2-diphenylethenyl)phenoxy)-n,n-diethyl-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

31. Ethanamine, 2-[4-(2-chloro-1,2-diphenylethenyl)phenoxy]-n,n-diethyl-,2-hydroxy-1,2,3-propanetricarboxylate (1:1)

32. Mer-41

33. Mrl-41

34. Unii-uy5x264qzv

35. Nsc 151466

36. Nsc-35770

37. Cas-50-41-9

38. Clomiphene Citrate, Cis-

39. Triethylamine, 2-(p-(2-chloro-1,2-diphenylvinyl)phenoxy)-, Citrate (1:1), (z)-

40. Mls001332629

41. Mls002207099

42. Schembl223472

43. Spectrum1500196

44. Sgcut00109

45. Chembl1213137

46. Hms501h04

47. Hy-b1617a

48. Hms1920o19

49. Hms2091g06

50. Hms2232d12

51. Pharmakon1600-01500196

52. Amy33425

53. Bcp03057

54. To_000032

55. Ccg-39553

56. Nsc151466

57. Nsc756698

58. S2561

59. Akos005111131

60. Bcp9000541

61. Ds-6814

62. Fd12066

63. Nsc-756698

64. Ncgc00017008-01

65. Ncgc00017008-02

66. Ncgc00017008-03

67. Ncgc00094626-01

68. Ncgc00094626-02

69. Ncgc00164385-01

70. Ac-19685

71. Ac-32011

72. Ethanamine, 2-(4-(2-chloro-1,2-diphenylethenyl)phenoxy)-n,n-diethyl-, (z)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

73. Bcp0726000214

74. Cs-0111663

75. Sw196898-3

76. C08161

77. Triethylamine,2-diphenylvinyl)phenoxy]-, Citrate

78. Sr-05000001591

79. Sr-05000001591-1

80. Q27291328

81. Triethylamine,2-diphenylvinyl)phenoxy]-, Citrate (1:1)

82. Triethylamine,2-diphenylvinyl)phenoxy]-, Citrate (1:1), (z)-

83. (2)2-[p-(2-chloro-1,2-diphenylvinyl)phenoxy]triethylamine Citrate (1:1)

84. 2-(4-[2-chloro-1,2-diphenylethenyl]phenoxy)-n,n-diethylethanamine Citrate Salt

85. {2-[4-(2-chloro-1,2-diphenylvinyl)phenoxy]ethyl}diethylamine 2-hydroxypropane-1,2,3-tricarboxylic Acid Salt

86. 2-({4-[(z)-2-chloro-1,2-diphenylethenyl]phenyl}oxy)-n,n-diethylethanamine 2-hydroxypropane-1,2,3-tricarboxylate (salt)

87. Ethanamine,2-diphenylethenyl)phenoxy]-n,n-diethyl-, (z)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

88. Ethanamine,2-diphenylethenyl)phenoxy]-n,n-diethyl-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

2.4 Create Date
2005-03-26
3 Chemical and Physical Properties
Molecular Weight 598.1 g/mol
Molecular Formula C32H36ClNO8
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count9
Rotatable Bond Count14
Exact Mass597.2129448 g/mol
Monoisotopic Mass597.2129448 g/mol
Topological Polar Surface Area145 Ų
Heavy Atom Count42
Formal Charge0
Complexity708
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 6  
Drug NameClomid
PubMed HealthClomiphene (By mouth)
Drug ClassesEndocrine-Metabolic Agent, Female Reproductive Agent
Drug LabelClomiphene citrate tablets, USP is an orally administered, nonsteroidal, ovulatory stimulant designated chemically as 2-[p-(2chloro-1,2-diphenylvinyl)phenoxy] triethylamine citrate (1:1). It has the molecular formula of C26H28CINO C6H8O7 and a mo...
Active IngredientClomiphene citrate
Dosage FormTablet
RouteOral
Strength50mg
Market StatusPrescription
CompanySanofi Aventis Us

2 of 6  
Drug NameClomiphene citrate
PubMed HealthClomiphene (By mouth)
Drug ClassesEndocrine-Metabolic Agent, Female Reproductive Agent
Drug LabelClomiPHENE citrate is an orally administered, nonsteroidal, ovulatory stimulant designated chemically as 2-[p-(2-chloro-1,2-diphenylvinyl) phenoxy] triethylamine citrate (1:1). It has a molecular formula of C26H28CINO C6H8O7 and a molecular weig...
Active IngredientClomiphene citrate
Dosage FormTablet
RouteOral
Strength50mg
Market StatusPrescription
CompanyPar Pharm

3 of 6  
Drug NameSerophene
Active IngredientClomiphene citrate
Dosage FormTablet
RouteOral
Strength50mg
Market StatusPrescription
CompanyEmd Serono

4 of 6  
Drug NameClomid
PubMed HealthClomiphene (By mouth)
Drug ClassesEndocrine-Metabolic Agent, Female Reproductive Agent
Drug LabelClomiphene citrate tablets, USP is an orally administered, nonsteroidal, ovulatory stimulant designated chemically as 2-[p-(2chloro-1,2-diphenylvinyl)phenoxy] triethylamine citrate (1:1). It has the molecular formula of C26H28CINO C6H8O7 and a mo...
Active IngredientClomiphene citrate
Dosage FormTablet
RouteOral
Strength50mg
Market StatusPrescription
CompanySanofi Aventis Us

5 of 6  
Drug NameClomiphene citrate
PubMed HealthClomiphene (By mouth)
Drug ClassesEndocrine-Metabolic Agent, Female Reproductive Agent
Drug LabelClomiPHENE citrate is an orally administered, nonsteroidal, ovulatory stimulant designated chemically as 2-[p-(2-chloro-1,2-diphenylvinyl) phenoxy] triethylamine citrate (1:1). It has a molecular formula of C26H28CINO C6H8O7 and a molecular weig...
Active IngredientClomiphene citrate
Dosage FormTablet
RouteOral
Strength50mg
Market StatusPrescription
CompanyPar Pharm

6 of 6  
Drug NameSerophene
Active IngredientClomiphene citrate
Dosage FormTablet
RouteOral
Strength50mg
Market StatusPrescription
CompanyEmd Serono

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Fertility Agents, Female

Compounds which increase the capacity to conceive in females. (See all compounds classified as Fertility Agents, Female.)


Estrogen Antagonists

Compounds which inhibit or antagonize the action or biosynthesis of estrogenic compounds. (See all compounds classified as Estrogen Antagonists.)


Selective Estrogen Receptor Modulators

A structurally diverse group of compounds distinguished from ESTROGENS by their ability to bind and activate ESTROGEN RECEPTORS but act as either an agonist or antagonist depending on the tissue type and hormonal milieu. They are classified as either first generation because they demonstrate estrogen agonist properties in the ENDOMETRIUM or second generation based on their patterns of tissue specificity. (Horm Res 1997;48:155-63) (See all compounds classified as Selective Estrogen Receptor Modulators.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Selective Estrogen Receptor Modulators [MoA]; Estrogen Agonist/Antagonist [EPC]

API Reference Price

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VAISHNODE","city":"AHMEDABAD","supplier":"MENADIONA SL","supplierCountry":"SPAIN","foreign_port":"NA","customer":"ZYDUS LIFESCIENCES LTD","customerCountry":"INDIA","quantity":"4.74","actualQuantity":"4.74","unit":"KGS","unitRateFc":"690","totalValueFC":"3601","currency":"EURO","unitRateINR":"62445","date":"24-Jun-2023","totalValueINR":"295989.057","totalValueInUsd":"3601","indian_port":"BOMBAY AIR","hs_no":"29221990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1688322600,"product":"CLOMIPHENE CITRATE 0298 \/ CAS 50-41-9","address":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam","city":"Kelambakkam","supplier":"FIS FABBRICA ITALIANA SINTETICI S P A","supplierCountry":"ITALY","foreign_port":"NA","customer":"PAR FORMULATIONS PRIVATE LTD","customerCountry":"INDIA","quantity":"225.00","actualQuantity":"225","unit":"KGS","unitRateFc":"1500","totalValueFC":"342738.6","currency":"USD","unitRateINR":"125198.2","date":"03-Jul-2023","totalValueINR":"28169521.85","totalValueInUsd":"342738.6","indian_port":"MADRAS AIR","hs_no":"29339990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691692200,"product":"CLOMIPHENE CITRATE USP 3817\/30016","address":"NO. 9\/215, PUDUPAKKAM - VANDALLUR, MAIN ROAD PUDUPAKKAM","city":"KELAMBAKKAM","supplier":"INTERCHEM CORP","supplierCountry":"SPAIN","foreign_port":"NA","customer":"PAR FORMULATIONS PRIVATE LTD","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"455","totalValueFC":"22913.8","currency":"USD","unitRateINR":"37582.3","date":"11-Aug-2023","totalValueINR":"1898096.2","totalValueInUsd":"22913.8","indian_port":"CHENNAI AIR","hs_no":"29339990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"NO. 9\/215, PUDUPAKKAM - VANDALLUR, MAIN ROAD PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1707071400,"product":"CLOMIPHENE CITRATE 0298 BATCH NO.202311150031 \/ 32 CAS NO.50-41-9","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"FIS FABBRICA ITALIANA SINTETICI S P A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"PAR FORMULATIONS PRIVATE LTD","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"1500","totalValueFC":"303529.6","currency":"USD","unitRateINR":"125925","date":"05-Feb-2024","totalValueINR":"25185000","totalValueInUsd":"303529.6","indian_port":"Madras Air","hs_no":"29339990","bill_no":"9987040","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"VIALE MILANO 26 36075MONTECCHIOMAGGIORE (VI) ITALY","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1707071400,"product":"CLOMIPHENE CITRATE 0298 BATCH NO.202311150031 CAS NO.50-41-9","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"FIS FABBRICA ITALIANA SINTETICI S P A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"PAR FORMULATIONS PRIVATE LTD","customerCountry":"INDIA","quantity":"275.00","actualQuantity":"275","unit":"KGS","unitRateFc":"1500","totalValueFC":"417353.2","currency":"USD","unitRateINR":"125925","date":"05-Feb-2024","totalValueINR":"34629375","totalValueInUsd":"417353.2","indian_port":"Madras Air","hs_no":"29339990","bill_no":"9987038","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"VIALE MILANO 26 36075MONTECCHIOMAGGIORE (VI) ITALY","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738953000,"product":"CLOMIPHENE CITRATE 0298 LOT NO.202405100038 CAS NO.50-41-9 TOLVAPTAN","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"FIS FABBRICA ITALIANA SINTETICI S P A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"PAR FORMULATIONS PRIVATE LTD","customerCountry":"INDIA","quantity":"300.00","actualQuantity":"300","unit":"KGS","unitRateFc":"1500","totalValueFC":"457430.2","currency":"USD","unitRateINR":"132600","date":"08-Feb-2025","totalValueINR":"39780000","totalValueInUsd":"457430.2","indian_port":"Madras Air","hs_no":"29339990","bill_no":"8250452","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"VIALE MILANO 26 36075 MONTECCHIO MAGGIORE (VI) ITALY","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"}]
10-Jan-2022
26-May-2025
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ABOUT THIS PAGE

Looking for 7619-53-6 / Clomiphene Citrate API manufacturers, exporters & distributors?

Clomiphene Citrate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Clomiphene Citrate 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 Clomiphene Citrate manufacturer or Clomiphene Citrate supplier for your needs.

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

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

API | Excipient name

Clomiphene Citrate

Synonyms

50-41-9, Zuclomiphene citrate, Cis-clomiphene citrate, Clomid, Zuclomid, Clomiphene a citrate

Cas Number

7619-53-6

Unique Ingredient Identifier (UNII)

UY5X264QZV

About Clomiphene Citrate

A triphenyl ethylene stilbene derivative which is an estrogen agonist or antagonist depending on the target tissue. Note that ENCLOMIPHENE and ZUCLOMIPHENE are the (E) and (Z) isomers of Clomiphene respectively.

Ardomon Manufacturers

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

Ardomon Suppliers

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

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

Ardomon USDMF

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

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

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

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

Ardomon CEP

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

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

Ardomon WC

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

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

Ardomon 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 Ardomon as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Ardomon 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 Ardomon 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 Ardomon and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ardomon NDC to their finished compounded human drug products, they may choose to do so.

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

Ardomon GMP

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

Ardomon CoA

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

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

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