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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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ACTIVE PHARMA INGREDIENTS

33 API Suppliers, 11 USDMF, 6 CEP/COS, 4 JDMF, 4 KDMF, 12 NDC API, 20 Listed Suppliers, $ API Reference Price

33 API Suppliers
11 USDMF
6 CEP/COS
4 JDMF
4 KDMF
12 NDC API
20 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

12 Drugs in Development

12 Drugs in Development

INTERMEDIATES

8 Intermediates Suppliers

8 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

127 FDF Dossiers, 26 FDA Orange Book, 54 Europe, 6 Canada, 14 Australia, 9 South Africa, 18 Listed Dossiers

127 FDF Dossiers
26 FDA Orange Book
54 Europe
6 Canada
14 Australia
9 South Africa
18 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - EQ 20MG BASE/10ML

drugProductComposition
TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;ORAL - EQ 20MG BASE/10ML

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 4 DKSH, 7 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 5 Actylis, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 24 BASF, 1 Bioplus Life Sciences, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 7 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 37 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 28 Roquette, 7 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

relatedExcipients
3 Rochem International Inc
17 SPI Pharma
2 Seqens
4 DKSH
7 Faran Shimi Pharmaceutical
4 Boai NKY Pharmaceuticals Ltd
13 Gangwal Healthcare
4 Nanjing Well Pharmaceutical
1 Pfanstiehl
1 ACG Worldwide
5 Actylis
7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
24 BASF
1 Bioplus Life Sciences
1 Clariant
10 Corel Pharma Chem
6 DFE Pharma
2 Finar
7 Gangwal Chemicals
5 Ideal Cures Pvt Ltd
4 Ingredion Pharma Solutions
37 Kerry
4 Kima Chemical
6 Lonza Capsugel
17 Microlex e.U
2 Nomisma Healthcare
2 Novo Excipients
2 Pharmatrans-Sanaq
8 Pluviaendo
4 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
1 Qualicaps
28 Roquette
7 Seppic
7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shanghai Welltone Material Technology Co., Ltd
2 Shijiazhuang Huaxu Pharmaceutical
10 Sigachi Industries
3 The Dow Chemical Company
1 Ulanqab Kema New Material
1 Valens Pharmachem
3 Vasa Pharmachem
1 Zhejiang Huakang Pharmaceutical

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DIGITAL CONTENT

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2 DATA COMPILATION #PharmaFlow
24 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 53 Finished Drug Prices

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2 US Medicaid Prescriptions
53 Finished Drug Prices

MARKET PLACE

6 APIs, 9 FDF Dossiers

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6 APIs
9 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM , 1 USP , 1 Others

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3 EDQM
1 USP
1 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 344

MARKET PLACE

API

FDF

8INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

127

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

12DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

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US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

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News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

13,630,100

Annual Reports (USD Million)

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276 RELATED EXCIPIENT COMPANIES

457EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 54965-24-1, Zitazonium, Istubal, Kessar, Zemide, Tamoxifen (citrate)

Molecular Formula

C₃₂H₃₇NO₈

Molecular Weight

563.6 g/mol

InChI Key

FQZYTYWMLGAPFJ-OQKDUQJOSA-N

FDA UNII

7FRV7310N6

One of the SELECTIVE ESTROGEN RECEPTOR MODULATORS with tissue-specific activities. Tamoxifen acts as an anti-estrogen (inhibiting agent) in the mammary tissue, but as an estrogen (stimulating agent) in cholesterol metabolism, bone density, and cell proliferation in the ENDOMETRIUM.

1 2D Structure

Tamoxifen Citrate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-[4-[(Z)-1,2-diphenylbut-1-enyl]phenoxy]-N,N-dimethylethanamine;2-hydroxypropane-1,2,3-tricarboxylic acid

2.1.2 InChI

InChI=1S/C26H29NO.C6H8O7/c1-4-25(21-11-7-5-8-12-21)26(22-13-9-6-10-14-22)23-15-17-24(18-16-23)28-20-19-27(2)3;7-3(8)1-6(13,5(11)12)2-4(9)10/h5-18H,4,19-20H2,1-3H3;13H,1-2H2,(H,7,8)(H,9,10)(H,11,12)/b26-25-;

2.1.3 InChI Key

FQZYTYWMLGAPFJ-OQKDUQJOSA-N

2.1.4 Canonical SMILES

CCC(=C(C1=CC=CC=C1)C2=CC=C(C=C2)OCCN(C)C)C3=CC=CC=C3.C(C(=O)O)C(CC(=O)O)(C(=O)O)O

2.1.5 Isomeric SMILES

CC/C(=C(\C1=CC=CC=C1)/C2=CC=C(C=C2)OCCN(C)C)/C3=CC=CC=C3.C(C(=O)O)C(CC(=O)O)(C(=O)O)O

2.2 Other Identifiers

2.2.1 UNII

7FRV7310N6

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Citrate, Tamoxifen

2. Ici 46,474

3. Ici 46474

4. Ici 47699

5. Ici-46,474

6. Ici-46474

7. Ici-47699

8. Ici46,474

9. Ici46474

10. Ici47699

11. Nolvadex

12. Novaldex

13. Soltamox

14. Tamoxifen

15. Tomaxithen

16. Zitazonium

2.3.2 Depositor-Supplied Synonyms

1. 54965-24-1

2. Zitazonium

3. Istubal

4. Kessar

5. Zemide

6. Tamoxifen (citrate)

7. Tamoxifen Citrate Salt

8. Nourytam

9. Tamofene

10. Tomaxasta

11. Ici 46474

12. Ici 46,474

13. Ici 46474 Citrate

14. Ici-46474

15. Nsc-180973

16. Nsc-757345

17. Tamoxifen Citrate (nolvadex)

18. 54965-24-1 (citrate)

19. 7frv7310n6

20. I.c.i.46474 Citrate

21. Nsc180973

22. Ncgc00024928-06

23. Cas-54965-24-1

24. Dsstox_cid_1301

25. (z)-2-(p-(1,2-diphenyl-1-butenyl)phenoxy)-n,n-dimethylethylamine Citrate (1:1)

26. Dsstox_rid_76068

27. Dsstox_gsid_21301

28. Ethanamine, 2-[4-(1,2-diphenyl-1-butenyl)phenoxy]-n,n-dimethyl-, (z)-,2-hydroxy-1,2,3-propanetricarboxylate (1:1)

29. Caditam

30. Farmifeno

31. Ginarsan

32. Jenoxifen

33. Ledertam

34. Nourytan

35. Noxitem

36. Oncotam

37. Tafoxen

38. Tamofen

39. Tamoxasta

40. Terimon

41. Zynoplex

42. Emblon

43. Genox

44. Nolgen

45. Noltam

46. Tamax

47. Tamoxifencitrate

48. Tamox-puren

49. (z)-2-(4-(1,2-diphenylbut-1-en-1-yl)phenoxy)-n,n-dimethylethanamine 2-hydroxypropane-1,2,3-tricarboxylate

50. 2-[4-[(z)-1,2-diphenylbut-1-enyl]phenoxy]-n,n-dimethylethanamine;2-hydroxypropane-1,2,3-tricarboxylic Acid

51. Ethanamine, 2-(4-(1,2-diphenyl-1-butenyl)phenoxy)-n,n-dimethyl, (z)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

52. Smr000677949

53. Z-tamoxifen Citrate

54. Sr-01000075523

55. Unii-7frv7310n6

56. Ccris 6718

57. Tamoxifeni Citras

58. Nolvadex (tn)

59. Soltamox (tn)

60. 2-{4-[(1z)-1,2-diphenylbut-1-en-1-yl]phenoxy}-n,n-dimethylethanamine 2-hydroxypropane-1,2,3-tricarboxylate (salt)

61. Prestwick_458

62. Einecs 259-415-2

63. Tamoxifen Citrate [usan:usp:jan]

64. Mfcd00058321

65. Tamoxifen (nolvadex)

66. Tamoxifen Citrate,(s)

67. Tamoxifen, Citrate Salt

68. Lopac-t-9262

69. Tamoxifen Z-isomer Citrate

70. Chembl786

71. Schembl6365

72. Mls001055370

73. Mls002154210

74. Spectrum1500557

75. Nolvadex (tn) (astrazeneca)

76. Tamoxifen Citrate [mi]

77. Tamoxifen Citrate [jan]

78. Dtxsid8021301

79. Tamoxifen Citrate (jp17/usp)

80. Tamoxifen Citrate [usan]

81. Hms500m20

82. Tamoxifen Citrate Salt, >=99%

83. Tamoxifen Citrate [vandf]

84. Tamoxifen Citrate [mart.]

85. Hms1568m14

86. Hms1921c13

87. Hms2092k17

88. Hms2095m14

89. Hms2232e08

90. Hms3263b08

91. Hms3675p04

92. Hms3712m14

93. Pharmakon1600-01500557

94. Tamoxifen Citrate [usp-rs]

95. Tamoxifen Citrate [who-dd]

96. Tamoxifen Citrate [who-ip]

97. Ex-a5777

98. Hydroxypropane-1,2,3-tricarboxylate

99. Tox21_110938

100. Tox21_202070

101. Tox21_300274

102. Tox21_501203

103. Ccg-39629

104. Nsc757345

105. S1238

106. S1972

107. Akos005111126

108. Tox21_110938_1

109. Cs-1852

110. Ks-5046

111. Lp01203

112. Tamoxifen Citrate [orange Book]

113. Tamoxifen Citrate [ep Monograph]

114. Ncgc00016206-01

115. Ncgc00016206-02

116. Ncgc00016206-03

117. Ncgc00016206-04

118. Ncgc00016206-05

119. Ncgc00016206-06

120. Ncgc00024928-02

121. Ncgc00024928-23

122. Ncgc00094450-01

123. Ncgc00094450-02

124. Ncgc00094450-03

125. Ncgc00094450-04

126. Ncgc00254000-01

127. Ncgc00259619-01

128. Ncgc00261888-01

129. Tamoxifen Citrate [usp Monograph]

130. Tamoxifeni Citras [who-ip Latin]

131. Hy-13757

132. Bcp0726000223

133. Tamoxifen Citrate - Cas 54965-24-1

134. Eu-0101203

135. Sw219368-1

136. T2510

137. (z)-2-(4-(1,2-diphenylbut-1-enyl)phenoxy)

138. A19582

139. D00966

140. T 9262

141. 965t241

142. Q-201776

143. Sr-01000075523-1

144. Sr-01000075523-3

145. Sr-01000075523-5

146. Sr-01000075523-6

147. Q27108378

148. Sr-01000075523-10

149. (z)-1-(4-dimethylaminoethoxyphenyl)-1,2-diphenyl-1-butene Citrate

150. Tamoxifen Citrate, European Pharmacopoeia (ep) Reference Standard

151. (z)-2-(4-(1,2-diphenyl-1-butenyl)phenoxy)-n,n-dimethylethanamine,citrate

152. (z)-2-[4-(1,2-diphenyl-1-butenyl)phenoxy]-n,n-dimethylethanamine Citrate

153. Tamoxifen Citrate, United States Pharmacopeia (usp) Reference Standard

154. (z)-2-[ P-(1,2-diphenyl-1-butenyl)phenoxy]- N, N-dimethylethylamine Citrate (1:1)

155. (z)-2-[4-(1,2-diphenyl-1-butenyl)phenoxy]-n,n-dimethyl-ethanamine Cirtrate (1:1)

156. Tamoxifen Citrate For Performance Test, European Pharmacopoeia (ep) Reference Standard

157. (2-{4-[1,2-diphenylbut-1-en-1-yl]phenoxy}ethyl)dimethylamine; 2-hydroxypropane-1,2,3-tricarboxylic Acid

158. (z)-(2-(4-(1,2-diphenylbut-1-enyl)phenoxy)ethyl)dimethylammonium Dihydrogen 2-hydroxypropane-1,2,3-tricarboxylate

159. (z)-2-(4-(1,2-diphenylbut-1-enyl)phenoxy)-n,n-dimethylethanamine 2-hydroxypropane-1,2,3-tricarboxylate

160. {2-[4-(1,2-diphenyl-1-buten-1-yl)phenoxy]ethyl}dimethylamine 2-hydroxy-1,2,3-propanetricarboxylate Salt

161. Ethanamine, 2-(4-((1z)-1,2-diphenyl-1-butenyl)phenoxy)-n,n-dimethyl-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

162. Ethanamine,2-diphenyl-1-butenyl)phenoxy]-n,n-dimethyl-, (z)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

2.4 Create Date

2005-03-26

3 Chemical and Physical Properties

Molecular Formula	C₃₂H₃₇NO₈
Molecular Weight	563.6 g/mol
Hydrogen Bond Donor Count	4
Hydrogen Bond Acceptor Count	9
Rotatable Bond Count	13
Exact Mass	563.25191714 g/mol
Monoisotopic Mass	563.25191714 g/mol
Topological Polar Surface Area	145 Å²
Heavy Atom Count	41
Formal Charge	0
Complexity	690
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	1
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Tamoxifen citrate
Drug Label	NOLVADEX (tamoxifen citrate) Tablets, a nonsteroidal antiestrogen, are for oral administration. NOLVADEX Tablets are available as:...
Active Ingredient	Tamoxifen citrate
Dosage Form	Tablet
Route	Oral
Strength	eq 20mg base; eq 10mg base
Market Status	Prescription
Company	Teva; Actavis Labs Fl; Apotex; Teva Pharms; Mylan

2 of 2
Drug Name	Tamoxifen citrate
Drug Label	NOLVADEX (tamoxifen citrate) Tablets, a nonsteroidal antiestrogen, are for oral administration. NOLVADEX Tablets are available as:...
Active Ingredient	Tamoxifen citrate
Dosage Form	Tablet
Route	Oral
Strength	eq 20mg base; eq 10mg base
Market Status	Prescription
Company	Teva; Actavis Labs Fl; Apotex; Teva Pharms; Mylan

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Antineoplastic Agents, Hormonal

Antineoplastic agents that are used to treat hormone-sensitive tumors. Hormone-sensitive tumors may be hormone-dependent, hormone-responsive, or both. A hormone-dependent tumor regresses on removal of the hormonal stimulus, by surgery or pharmacological block. Hormone-responsive tumors may regress when pharmacologic amounts of hormones are administered regardless of whether previous signs of hormone sensitivity were observed. The major hormone-responsive cancers include carcinomas of the breast, prostate, and endometrium; lymphomas; and certain leukemias. (From AMA Drug Evaluations Annual 1994, p2079) (See all compounds classified as Antineoplastic Agents, Hormonal.)

Bone Density Conservation Agents

Agents that inhibit BONE RESORPTION and/or favor BONE MINERALIZATION and BONE REGENERATION. They are used to heal BONE FRACTURES and to treat METABOLIC BONE DISEASES such as OSTEOPOROSIS. (See all compounds classified as Bone Density Conservation Agents.)

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]

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TAMOXIFEN CITRATE USP

GDUFA

DMF Review : Complete

Rev. Date : 2014-10-01

Pay. Date : 2013-10-24

DMF Number : 5500

Submission : 1984-08-15

Status : Active

Type : II

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API Reference Price

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RIVOLTANAKM 6\/7 20053 RODANO (MI)IT SDNF","customerAddress":"VILLAGE NAG KALAN,MAJITHA ROAD,MAJ"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720031400,"product":"TAMOXIFEN CITRATE USP","address":"PLOT NO.2, MAITHRIVIHAR,","city":"HYDERABAD, AP.","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"EUGIA PHARMA SPECIALITIES ","customerCountry":"INDIA","quantity":"506.90","actualQuantity":"506.9","unit":"KGS","unitRateFc":"540","totalValueFC":"298642.1","currency":"EUR","unitRateINR":"49248","date":"04-Jul-2024","totalValueINR":"24963811.2","totalValueInUsd":"298642.1","indian_port":"Hyderabad Air","hs_no":"29221990","bill_no":"4327031","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"DIREZIONE E UFFICI STR RIVOLTANA KM6\/7 20053 RODANO (MI)SDNF Italy","customerAddress":"PLOT NO.2, MAITHRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720463400,"product":"TAMOXIFEN CITRATE (TAMOXIFEN CITRATE MILLED)","address":"NO.18,DR NAIR ROAD, T NAGAR,","city":"CHENNAI","supplier":"RELONCHEM LIMITED","supplierCountry":"UNITED KINGDOM","foreign_port":"LONDON - HEATHROW","customer":"STERIL-GENE LIFE SCIENCES (P) LTD","customerCountry":"INDIA","quantity":"250.60","actualQuantity":"250.6","unit":"KGS","unitRateFc":"560.1","totalValueFC":"181779.8","currency":"GBP","unitRateINR":"60635.2","date":"09-Jul-2024","totalValueINR":"15195169.41","totalValueInUsd":"181779.8","indian_port":"Madras Air","hs_no":"29420090","bill_no":"4411132","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"LONDON - HEATHROW","supplierAddress":"CHESHIRE HOUSE GORSEY LANEWIDNES CHESHIRE WA8 0RPUNITED KINGDOM UNITED KINGDOM","customerAddress":"NO.18,DR NAIR ROAD, T NAGAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725820200,"product":"TAMOXIFEN CITRATE USP (CAS NO:54965-24-1)","address":"PLOT NO.2, MAITHRIVIHAR,","city":"HYDERABAD, AP.","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"EUGIA PHARMA SPECIALITIES ","customerCountry":"INDIA","quantity":"58.10","actualQuantity":"58.1","unit":"KGS","unitRateFc":"540","totalValueFC":"35473.1","currency":"EUR","unitRateINR":"51165","date":"09-Sep-2024","totalValueINR":"2972686.5","totalValueInUsd":"35473.1","indian_port":"Hyderabad Air","hs_no":"29221990","bill_no":"5503574","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"DIREZIONE E UFFICI STR RIVOLTANA KM 6\/7 20053 RODANO (MI) SDNF Italy","customerAddress":"PLOT NO.2, MAITHRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725820200,"product":"TAMOXIFEN CITRATE USP (CAS NO:54965-24-1)","address":"PLOT NO.2, MAITHRIVIHAR,","city":"HYDERABAD, AP.","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"EUGIA PHARMA SPECIALITIES ","customerCountry":"INDIA","quantity":"423.90","actualQuantity":"423.9","unit":"KGS","unitRateFc":"540","totalValueFC":"258813","currency":"EUR","unitRateINR":"51165","date":"09-Sep-2024","totalValueINR":"21688843.5","totalValueInUsd":"258813","indian_port":"Hyderabad Air","hs_no":"29221990","bill_no":"5503574","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"DIREZIONE E UFFICI STR RIVOLTANA KM 6\/7 20053 RODANO (MI) SDNF Italy","customerAddress":"PLOT NO.2, MAITHRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728930600,"product":"TAMOXIFEN CITRATE USP","address":"PLOT NO.2, MAITHRIVIHAR,","city":"HYDERABAD, AP.","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"EUGIA PHARMA SPECIALITIES ","customerCountry":"INDIA","quantity":"110.70","actualQuantity":"110.7","unit":"KGS","unitRateFc":"540","totalValueFC":"67051.1","currency":"EUR","unitRateINR":"50895","date":"15-Oct-2024","totalValueINR":"5634076.5","totalValueInUsd":"67051.1","indian_port":"Hyderabad Air","hs_no":"29221990","bill_no":"6130043","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"STRADA RIVOLTANA KM 6\/7 RODANO (MI) 20053 ITALY. SDNF Italy","customerAddress":"PLOT NO.2, MAITHRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731522600,"product":"TAMOXIFEN CITRATE USP (CAS NO:54965-24-1)","address":"PLOT NO.2, MAITHRIVIHAR,","city":"HYDERABAD, AP.","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"EUGIA PHARMA SPECIALITIES ","customerCountry":"INDIA","quantity":"497.80","actualQuantity":"497.8","unit":"KGS","unitRateFc":"540","totalValueFC":"293855.2","currency":"EUR","unitRateINR":"49815","date":"14-Nov-2024","totalValueINR":"24797907","totalValueInUsd":"293855.2","indian_port":"Hyderabad Air","hs_no":"29221990","bill_no":"6675660","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"STRADA RIVOLTANA KM 6\/7 RODANO MI 2 0053 ITALY SDNF Italy","customerAddress":"PLOT NO.2, MAITHRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732818600,"product":"TAMOXIFEN CITRATE USP\/EP","address":"VILLAGE NAG KALAN,MAJITHA ROAD,MAJ","city":"AMRITSAR,PUNJAB","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"KWALITY PHARMACEUTICALS","customerCountry":"INDIA","quantity":"38.00","actualQuantity":"38","unit":"KGS","unitRateFc":"680","totalValueFC":"27803.3","currency":"EUR","unitRateINR":"61744","date":"29-Nov-2024","totalValueINR":"2346272","totalValueInUsd":"27803.3","indian_port":"Delhi Air","hs_no":"29339990","bill_no":"6956057","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"DIREZIONE E UFFICI STR RIVOLTANA KM 6\/7 20053 RODANO (MI) IT SDNF","customerAddress":"VILLAGE NAG KALAN,MAJITHA ROAD,MAJ"}]

Number of Transactions

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DOSAGE - TABLET;ORAL - EQ 10MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 17970

DOSAGE - TABLET;ORAL - EQ 20MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 17970

DOSAGE - SOLUTION;ORAL - EQ 20MG BASE/10ML

USFDA APPLICATION NUMBER - 21807

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ABOUT THIS PAGE

Tamoxifen Citrate Manufacturers

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

Tamoxifen Citrate Suppliers

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

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

Tamoxifen Citrate USDMF

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

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

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

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

Tamoxifen Citrate KDMF

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

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

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

click here to find a list of Tamoxifen Citrate suppliers with KDMF on PharmaCompass.

Tamoxifen Citrate CEP

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

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

Tamoxifen Citrate 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 Tamoxifen Citrate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Tamoxifen Citrate GMP

Tamoxifen Citrate 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 Tamoxifen Citrate 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 Tamoxifen Citrate GMP manufacturer or Tamoxifen Citrate GMP API supplier for your needs.

Tamoxifen Citrate CoA

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

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

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

TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;ORAL - EQ 20MG BASE/10ML

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TABLET;ORAL - EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons