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Synopsis

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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Tamsulosin HCl IP/USP/EP

Date of Issue : 2022-07-07

Valid Till : 2025-07-21

Written Confirmation Number : WC-0150

Address of the Firm : R. S. No. 50/1, Mukteswarapuram (V), Jaggalahpet (M), Krishna -District- 521175,...

Cohance

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Tamsulosin Hydrochloride (Ph.Eur.)

Date of Issue : 2022-06-06

Valid Till : 2025-06-10

Written Confirmation Number : WC-0017

Address of the Firm : Unit No. VIII, Sy. No. 10 & 13, Gaddapotharam Village, I,D.A. Kazipally, Jinnara...

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Cipla

India
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Tamsulosin HCl BP/EP

Date of Issue : 2022-06-17

Valid Till : 2025-08-04

Written Confirmation Number : WC-0142n

Address of the Firm : Plot. A-33, A-37/2/2 MIDC, Patalganga-410 220, Dist. Raigad, Maharashtra

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Tamsulosin Hydrochloride (BP/USP/Ph.Eur)

Date of Issue : 2022-06-16

Valid Till : 2025-06-16

Written Confirmation Number : WC-0031

Address of the Firm : Unit-Lingojigudem (V) Choutuppal (M) Nalgonda District Talangana State India

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Tamsulosin Hydrochloride (USP/BP/EP)

Date of Issue : 2022-05-02

Valid Till : 2025-07-25

Written Confirmation Number : WC-0027

Address of the Firm : Unit-II, Survey No.14, IDA Gaddapotharam (Village), Kazipally, Jinnaram (Mandal)...

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Tamsulosin Hydrochloride (USP/EP)

Date of Issue : 2022-06-08

Valid Till : 2025-06-02

Written Confirmation Number : WC-0011nA2

Address of the Firm : Village toansa, P.O Rail Majra, District S.B.S nagar nawanshahar-144533 Punjab I...

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Tamsulosin Hydrochloride (/USP/Ph. Eur.)

Date of Issue : 2019-07-15

Valid Till : 2022-07-14

Written Confirmation Number : WC-0042

Address of the Firm : Plot No.262, 263, IDA, Pashamylaram, Medak District, A.P

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Tamsulosin Hydrochloride IP/USP/EP

Date of Issue : 2022-06-30

Valid Till : 2025-07-02

Written Confirmation Number : WC-0231

Address of the Firm : D No.6/223 Sarpavaram Kakinada AP

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Tamsulosin Hydrochloride EP

Date of Issue : 2022-06-30

Valid Till : 2025-07-28

Written Confirmation Number : WC-0063

Address of the Firm : Plot No. 99, MIDC Area, Dhatav, Roha, Dist Raigad

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Wockhardt

India
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Wockhardt

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Tamsulosin Hydrochloride (EP)

Date of Issue : 2019-07-22

Valid Till : 2022-07-21

Written Confirmation Number : WC-0075

Address of the Firm : Plot No.138, GIDC, At & Post Ankleshwar, Dist- Bharuch, Gujarat, India

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API Reference Price

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FOR ","customerCountry":"IRAQ","quantity":"250.00","actualQuantity":"250","unit":"KGS","unitRateFc":"45.3","totalValueFC":"9946.2","currency":"USD","unitRateINR":3380.4840800000002,"date":"31-Dec-2024","totalValueINR":"845121.02","totalValueInUsd":"9946.2","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"6926278","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"IRAQ","selfForZScoreResived":"Pellets","supplierPort":"Hyderabad Air","supplierAddress":"MANISHA PLAZA SONAPUR LANE,, MUMBAI,MAHARASHTRA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1669746600,"product":"TAMSULOSIN HCL SR PELLETS 0.2 PERCENT","address":"SYNO.257 258\/1, DNO.11-6\/56,","city":"VILLAGE BALANGAR POST HYDERABAD","supplier":"MM FARMACHEM D.O.O","supplierCountry":"CROATIA","foreign_port":"N\/A","customer":"LEE PHARMA","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"118","totalValueFC":"59713.8","currency":"USD","unitRateINR":"9746.8","date":"30-Nov-2022","totalValueINR":"4873400","totalValueInUsd":"59713.8","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29333990","bill_no":"1001756","productDescription":"API","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pellets","supplierPort":"N\/A","supplierAddress":"N\/A","customerAddress":"SYNO.257 258\/1, DNO.11-6\/56,"},{"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 PHARMACOPEIA - INDIA 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,"}]
02-Jan-2021
31-Dec-2024
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DRUG PRODUCT COMPOSITIONS

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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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01

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VMX
Not Confirmed
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Tamsulosin

Brand Name : FLOMAX CR

Patent Number : 2490299

Filing Date : 2003-12-24

Strength per Unit : 0.4mg

Dosage Form : Tablet

Human Or VET : Human

Route of Administration : Oral

Patent Expiration Date : 2023-12-24

Date Granted : 2008-08-26

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02

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Tamsulosin

Brand Name : FLOMAX CR

Patent Number : 2144077

Filing Date : 1993-09-10

Strength per Unit : 0.4mg

Dosage Form : Tablet

Human Or VET : Human

Route of Administration : Oral

Patent Expiration Date : 2013-09-10

Date Granted : 2005-05-24

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03

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Tamsulosin

Brand Name :

Patent Number : 1264293

Filing Date :

Strength per Unit :

Dosage Form :

Human Or VET :

Route of Administration :

Patent Expiration Date : 2007-01-09

Date Granted :

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ABOUT THIS PAGE

Tamsulosin Hydrochloride Manufacturers

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

Tamsulosin Hydrochloride Suppliers

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

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

Tamsulosin Hydrochloride USDMF

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

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

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

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

Tamsulosin Hydrochloride KDMF

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

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

After submitting a Tamsulosin Hydrochloride 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 Tamsulosin Hydrochloride API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Tamsulosin Hydrochloride suppliers with KDMF on PharmaCompass.

Tamsulosin Hydrochloride CEP

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

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

Tamsulosin Hydrochloride WC

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

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

Tamsulosin Hydrochloride 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 Tamsulosin Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Tamsulosin Hydrochloride GMP

Tamsulosin Hydrochloride 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 Tamsulosin Hydrochloride 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 Tamsulosin Hydrochloride GMP manufacturer or Tamsulosin Hydrochloride GMP API supplier for your needs.

Tamsulosin Hydrochloride CoA

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

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

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