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Chemistry

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Also known as: 106463-17-6, Flomax, Tamsulosin hcl, Omnic, Pradif, Harnal
Molecular Formula
C20H29ClN2O5S
Molecular Weight
445.0  g/mol
InChI Key
ZZIZZTHXZRDOFM-XFULWGLBSA-N
FDA UNII
11SV1951MR

Tamsulosin
A sulfonamide derivative and adrenergic alpha-1 receptor antagonist that is used to relieve symptoms of urinary obstruction caused by BENIGN PROSTATIC HYPERPLASIA.
1 2D Structure

Tamsulosin

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
5-[(2R)-2-[2-(2-ethoxyphenoxy)ethylamino]propyl]-2-methoxybenzenesulfonamide;hydrochloride
2.1.2 InChI
InChI=1S/C20H28N2O5S.ClH/c1-4-26-17-7-5-6-8-18(17)27-12-11-22-15(2)13-16-9-10-19(25-3)20(14-16)28(21,23)24;/h5-10,14-15,22H,4,11-13H2,1-3H3,(H2,21,23,24);1H/t15-;/m1./s1
2.1.3 InChI Key
ZZIZZTHXZRDOFM-XFULWGLBSA-N
2.1.4 Canonical SMILES
CCOC1=CC=CC=C1OCCNC(C)CC2=CC(=C(C=C2)OC)S(=O)(=O)N.Cl
2.1.5 Isomeric SMILES
CCOC1=CC=CC=C1OCCN[C@H](C)CC2=CC(=C(C=C2)OC)S(=O)(=O)N.Cl
2.2 Other Identifiers
2.2.1 UNII
11SV1951MR
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide

2. Flomax

3. Ly 253352

4. Ly-253352

5. Tamsulosin

6. Ym 617

7. Ym-617

2.3.2 Depositor-Supplied Synonyms

1. 106463-17-6

2. Flomax

3. Tamsulosin Hcl

4. Omnic

5. Pradif

6. Harnal

7. Urolosin

8. Secotex

9. Josir

10. Alna

11. Omic

12. Omix

13. Ym617

14. Ly253351

15. Amsulosin Hydrochloride

16. Tamsulosin (hydrochloride)

17. (r)-5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide Hydrochloride

18. R-(-)-ym-12617

19. Ym 617

20. Ym-12617-1

21. Ym-617

22. Ly-253351

23. Chebi:9399

24. (-)-(r)-5-(2-((2-(o-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide Monohydrochloride

25. 11sv1951mr

26. 5-[(2r)-2-[[2-(2-ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide Hydrochloride

27. 5-[(2r)-2-[2-(2-ethoxyphenoxy)ethylamino]propyl]-2-methoxybenzenesulfonamide;hydrochloride

28. 5-[(r)-2-[2-(2-ethoxyphenoxy)ethylamino]propyl]]-2-methoxybenzenesulfonamide Hydrochloride

29. R-(-)-5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide Hydrochloride

30. Expros

31. Flomax (tn)

32. Dsstox_cid_26628

33. Dsstox_rid_81777

34. Dsstox_gsid_46628

35. 128332-25-2

36. Benzenesulfonamide, 5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxy-, Monohydrochloride, (r)-

37. (r)-5-(2-(2-(2-ethoxyphenoxy)ethylamino)propyl)-2-methoxybenzenesulfonamide Hydrochloride

38. (-)-(r)-5-(2-((2-(o-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzene Sulfonamide Monohydrochloride

39. Cas-106463-17-6

40. Tamsulosine Hydrochloride

41. Ncgc00167442-01

42. Mfcd00922997

43. (r)-tamsulosin Hydrochloride

44. Unii-11sv1951mr

45. Tamsulosin.hcl

46. Harnalidge Ocas

47. Flomax Mr

48. Alnaocas

49. 5-[(2r)-2-{[2-(2-ethoxyphenoxy)ethyl]amino}propyl]-2-methoxybenzenesulfonamide Hydrochloride

50. Flomax Hydrochloride

51. Harnal (tn)

52. Tamsulosin Hydrochloride [usan:usp:jan]

53. Tamsulosina Hydrochloride

54. Tamsulosinum Hydrochloride

55. (-)-ly 253352

56. Schembl23428

57. Tamsulosin Hydrochloride,(s)

58. Mls003899197

59. Racemic Tamsulosin Hydrochloride

60. Chembl1200914

61. Dtxsid2046628

62. Hy-b0661a

63. 5-[(2rs)-2-[[2-(2-ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide Hydrochloride (tamsulosin Racemate Hydrochloride)

64. Tox21_112446

65. Eu-617

66. S4729

67. (r)-tamsulosin Hydrochloride- Bio-x

68. Tamsulosin Hydrochloride (jp17/usp)

69. Tamsulosin Hydrochloride [jan]

70. Akos015895342

71. Akos015995287

72. Tox21_112446_1

73. Bs-1019

74. Ccg-269178

75. Tamsulosin Hydrochloride [usan]

76. (-)-ly253352

77. Tamsulosin Hydrochloride [mart.]

78. Tamsulosin Hydrochloride [vandf]

79. Ncgc00167442-03

80. Tamsulosin Hydrochloride [usp-rs]

81. Tamsulosin Hydrochloride [who-dd]

82. Bt164440

83. Smr002543366

84. Bcp0726000042

85. Tamsulosin Hydrochloride, >=98% (hplc)

86. T2749

87. Y-617

88. Tamsulosin Hydrochloride [orange Book]

89. A14936

90. D01024

91. Jalyn Component Tamsulosin Hydrochloride

92. Tamsulosin Hydrochloride [ep Monograph]

93. Tamsulosin Hydrochloride [usp Impurity]

94. Tamsulosin Hydrochloride [usp Monograph]

95. 463t176

96. A801444

97. Tamsulosin Hydrochloride Component Of Jalyn

98. Q-201777

99. (r)-(-)-ym12617;ly253351

100. (r)-5-(2-(2-(2-ethoxyphenoxy)ethylamino)propyl)-2

101. Q27108379

102. Tamsulosin Hydrochloride, British Pharmacopoeia (bp) Reference Standard

103. Tamsulosin Hydrochloride, European Pharmacopoeia (ep) Reference Standard

104. (r)-5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide Hcl

105. 5-((2r)-2-(2-(2-ethoxyphenoxy)ethylamino)propyl)-2-methoxybenzene-sulfonamide Hcl

106. 5-[(r)-2-[2-(2-ethoxyphenoxy)ethylamino]propyl]]-2-methoxybenzenesulfonamidehydrochloride

107. Tamsulosin Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

108. Tamsulosin Hydrochloride, United States Pharmacopeia (usp) Reference Standard

109. (r)-5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide Monohydrochloride

110. 5-[(2r)-2-[[2-(-ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide Hydrochloride;tamsulosin Hcl

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 445.0 g/mol
Molecular Formula C20H29ClN2O5S
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count7
Rotatable Bond Count11
Exact Mass444.1485709 g/mol
Monoisotopic Mass444.1485709 g/mol
Topological Polar Surface Area108 Ų
Heavy Atom Count29
Formal Charge0
Complexity539
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameFlomax
PubMed HealthTamsulosin (By mouth)
Drug ClassesBenign Prostatic Hypertrophy Agent
Drug LabelTamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate.Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white...
Active IngredientTamsulosin hydrochloride
Dosage FormCapsule
RouteOral
Strength0.4mg
Market StatusPrescription
CompanyBoehringer Ingelheim

2 of 4  
Drug NameTamsulosin hydrochloride
Drug LabelTamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate.Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white...
Active IngredientTamsulosin hydrochloride
Dosage FormCapsule
Routeoral; Oral
Strength0.4mg
Market StatusTentative Approval; Prescription
CompanySynthon Pharms; Anchen Pharms; Wockhardt; Ranbaxy; Aurobindo Pharma; Sun Pharm Inds; Sandoz; Teva Pharms; Zydus Pharms Usa; Mylan; Impax Labs

3 of 4  
Drug NameFlomax
PubMed HealthTamsulosin (By mouth)
Drug ClassesBenign Prostatic Hypertrophy Agent
Drug LabelTamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate.Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white...
Active IngredientTamsulosin hydrochloride
Dosage FormCapsule
RouteOral
Strength0.4mg
Market StatusPrescription
CompanyBoehringer Ingelheim

4 of 4  
Drug NameTamsulosin hydrochloride
Drug LabelTamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate.Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white...
Active IngredientTamsulosin hydrochloride
Dosage FormCapsule
Routeoral; Oral
Strength0.4mg
Market StatusTentative Approval; Prescription
CompanySynthon Pharms; Anchen Pharms; Wockhardt; Ranbaxy; Aurobindo Pharma; Sun Pharm Inds; Sandoz; Teva Pharms; Zydus Pharms Usa; Mylan; Impax Labs

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Urological Agents

Drugs used in the treatment of urological conditions and diseases such as URINARY INCONTINENCE and URINARY TRACT INFECTIONS. (See all compounds classified as Urological Agents.)


Adrenergic alpha-1 Receptor Antagonists

Drugs that bind to and block the activation of ADRENERGIC ALPHA-1 RECEPTORS. (See all compounds classified as Adrenergic alpha-1 Receptor Antagonists.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
alpha-Adrenergic Blocker [EPC]; Adrenergic alpha-Antagonists [MoA]

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AP.","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1659637800,"product":"TAMSULOSIN HYDROCHLORIDE (B) 103569 TU0A1303","address":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam","city":"Kelambakkam","supplier":"CHEMO IBERICA SA","supplierCountry":"SPAIN","foreign_port":"NA","customer":"PAR FORMULATIONS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"7500","totalValueFC":"7564.4","currency":"USD","unitRateINR":"601875","date":"05-Aug-2022","totalValueINR":"601875","totalValueInUsd":"7564.4","indian_port":"MADRAS AIR","hs_no":"29349990","bill_no":"9880115","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1694716200,"product":"TAMSULOSIN HYDROCHLORIDE (QTY: 14 X 200 MG, VALUE: USD 2543\/EACH)(FOC)","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"USP","supplierCountry":"INDIA","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIAINDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0028","unit":"KGS","unitRateFc":"12715000","totalValueFC":"36709.3","currency":"USD","unitRateINR":"1088277504","date":"15-Sep-2023","totalValueINR":"3047177.01","totalValueInUsd":"36709.3","indian_port":"Hyderabad Air","hs_no":"29359090","bill_no":"7839907","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,MD 21704 USA.SDNF United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712082600,"product":"TAMSULOSIN HYDROCHLORIDE-103569 - TAMSULOSIN HYDROCHLORIDE (B)","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"CHEMO IBERICA SA","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"MYLAN LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"2.93","actualQuantity":"2.93","unit":"KGS","unitRateFc":"6500","totalValueFC":"19157.4","currency":"USD","unitRateINR":"546000","date":"03-Apr-2024","totalValueINR":"1599780","totalValueInUsd":"19157.4","indian_port":"Bombay Air","hs_no":"29331999","bill_no":"2864063","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"MADRID","supplierAddress":"Manuel Pombo Angulo, 28, 3rd floor28050 Madrid - SpainSDNF Spain","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748025000,"product":"TAMSULOSIN HCL BATCH NO 104230036 POTASSIUM CLAVULANATE","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"ENDO OPERATIONS (GX\/SI SUPPLY)","supplierCountry":"UNITED STATES","foreign_port":"LOS ANGELES","customer":"PAR FORMULATIONS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"3.91","actualQuantity":"3.9065","unit":"KGS","unitRateFc":"80061.2","totalValueFC":"317161.7","currency":"N\/A","unitRateINR":"6917287.1","date":"24-May-2025","totalValueINR":"27022382.24","totalValueInUsd":"317161.7","indian_port":"Madras Air","hs_no":"29359090","bill_no":"2255200","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"LOS ANGELES","supplierAddress":"1ST FLOOR MINERVA HOUSE SIM MONS COURTS ROAD BALLS BRIDGE, DUBLIN 4 IRELAND","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"}]
05-Jan-2022
31-May-2025
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DOSAGE - CAPSULE;ORAL - 0.4MG

USFDA APPLICATION NUMBER - 20579

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DOSAGE - CAPSULE;ORAL - 0.5MG;0.4MG

USFDA APPLICATION NUMBER - 22460

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ABOUT THIS PAGE

Looking for 106463-17-6 / Tamsulosin API manufacturers, exporters & distributors?

Tamsulosin manufacturers, exporters & distributors 1

18

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

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

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

API | Excipient name

Tamsulosin

Synonyms

106463-17-6, Flomax, Tamsulosin hcl, Omnic, Pradif, Harnal

Cas Number

106463-17-6

Unique Ingredient Identifier (UNII)

11SV1951MR

About Tamsulosin

A sulfonamide derivative and adrenergic alpha-1 receptor antagonist that is used to relieve symptoms of urinary obstruction caused by BENIGN PROSTATIC HYPERPLASIA.

Harnalidge OCAS Manufacturers

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

Harnalidge OCAS Suppliers

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

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

Harnalidge OCAS USDMF

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

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

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

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

Harnalidge OCAS KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Harnalidge OCAS Drug Master File in Korea (Harnalidge OCAS KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Harnalidge OCAS. The MFDS reviews the Harnalidge OCAS KDMF as part of the drug registration process and uses the information provided in the Harnalidge OCAS KDMF to evaluate the safety and efficacy of the drug.

After submitting a Harnalidge OCAS KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Harnalidge OCAS API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Harnalidge OCAS suppliers with KDMF on PharmaCompass.

Harnalidge OCAS CEP

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

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

Harnalidge OCAS WC

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

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

Harnalidge OCAS 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 Harnalidge OCAS as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Harnalidge OCAS GMP

Harnalidge OCAS 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 Harnalidge OCAS 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 Harnalidge OCAS GMP manufacturer or Harnalidge OCAS GMP API supplier for your needs.

Harnalidge OCAS CoA

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

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

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