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Raloxifene Hydrochloride

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

32 API Suppliers, 18 USDMF, 12 CEP/COS, 6 JDMF, 9 EU WC, 7 KDMF, 13 NDC API, 22 Listed Suppliers, $ API Reference Price

32 API Suppliers
18 USDMF
12 CEP/COS
6 JDMF
9 EU WC
7 KDMF
13 NDC API
22 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

INTERMEDIATES

31 Intermediates Suppliers

31 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

61 FDF Dossiers, 10 FDA Orange Book, 33 Europe, 5 Canada, 8 Australia, 1 South Africa, 4 Listed Dossiers

61 FDF Dossiers
10 FDA Orange Book
33 Europe
5 Canada
8 Australia
1 South Africa
4 Listed Dossiers

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1 Minakem, 1 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 3 DKSH, 5 Faran Shimi Pharmaceutical, 8 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 12 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 26 BASF, 2 Clariant, 10 Corel Pharma Chem, 5 DFE Pharma, 2 Finar, 12 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 37 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 2 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 17 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem

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

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89 Fillers, Diluents & Binders, 46 Direct Compression, 46 Coating Systems & Additives, 31 Solubilizers, 29 Thickeners and Stabilizers, 28 Controlled & Modified Release, 25 Disintegrants & Superdisintegrants, 25 Granulation, 22 Co-Processed Excipients, 22 Lubricants & Glidants, 20 Chewable & Orodispersible Aids, 19 Parenteral, 18 Topical, 15 Taste Masking, 14 Film Formers & Plasticizers, 9 Emulsifying Agents, 7 API Stability Enhancers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 Coloring Agents, 4 Rheology Modifiers

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 28 NEWS #PharmaBuzz

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2 DATA COMPILATION #PharmaFlow
28 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 29 Finished Drug Prices, 3 Annual Reports

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2 US Medicaid Prescriptions
29 Finished Drug Prices
3 Annual Reports

MARKET PLACE

3 APIs

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3 APIs

PATENTS & EXCLUSIVITIES

6 Health Canada Patents

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6 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM , 2 USP , 2 Others

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2 EDQM
2 USP
2 Others

ANALYTICAL

3 BioAnalytical Methods

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3 BioAnalytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 877

MARKET PLACE

API

FDF

31INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

5DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

73,227,593

Annual Reports (USD Million)

533

Finished Drug Prices

277 RELATED EXCIPIENT COMPANIES

486EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 82640-04-8, Raloxifene hcl, Evista, Keoxifene hydrochloride, Keoxifene, Optruma

Molecular Formula

C₂₈H₂₈ClNO₄S

Molecular Weight

510.0 g/mol

InChI Key

BKXVVCILCIUCLG-UHFFFAOYSA-N

FDA UNII

4F86W47BR6

A second generation selective estrogen receptor modulator (SERM) used to prevent osteoporosis in postmenopausal women. It has estrogen agonist effects on bone and cholesterol metabolism but behaves as a complete estrogen antagonist on mammary gland and uterine tissue.

1 2D Structure

Raloxifene Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

[6-hydroxy-2-(4-hydroxyphenyl)-1-benzothiophen-3-yl]-[4-(2-piperidin-1-ylethoxy)phenyl]methanone;hydrochloride

2.1.2 InChI

InChI=1S/C28H27NO4S.ClH/c30-21-8-4-20(5-9-21)28-26(24-13-10-22(31)18-25(24)34-28)27(32)19-6-11-23(12-7-19)33-17-16-29-14-2-1-3-15-29;/h4-13,18,30-31H,1-3,14-17H2;1H

2.1.3 InChI Key

BKXVVCILCIUCLG-UHFFFAOYSA-N

2.1.4 Canonical SMILES

C1CCN(CC1)CCOC2=CC=C(C=C2)C(=O)C3=C(SC4=C3C=CC(=C4)O)C5=CC=C(C=C5)O.Cl

2.2 Other Identifiers

2.2.1 UNII

4F86W47BR6

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Evista

2. Keoxifene

3. Keoxifene Hydrochloride

4. Ly 139481

5. Ly 156758

6. Ly-139481

7. Ly-156758

8. Ly139481

9. Ly156758

10. Raloxifene

11. Raloxifene Hcl

2.3.2 Depositor-Supplied Synonyms

1. 82640-04-8

2. Raloxifene Hcl

3. Evista

4. Keoxifene Hydrochloride

5. Keoxifene

6. Optruma

7. Raloxifene Teva

8. (6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thiophen-3-yl)(4-(2-(piperidin-1-yl)ethoxy)phenyl)methanone Hydrochloride

9. Raloxifene (hydrochloride)

10. Ly 156758

11. Ly156758

12. Ly-156758

13. Nsc-706725

14. 2-(4-hydroxyphenyl)-3-({4-[2-(piperidin-1-yl)ethoxy]phenyl}carbonyl)-1-benzothiophen-6-ol Hydrochloride

15. Chebi:50740

16. Evista (raloxifene Hydrochloride)

17. 4f86w47br6

18. 6-hydroxy-2-(p-hydroxyphenyl)benzo(b)thien-3-yl-p-(2-piperidinoethoxy)phenyl Ketone, Hydrochloride

19. Dsstox_cid_14181

20. Dsstox_rid_79119

21. Dsstox_gsid_34181

22. [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl][4-[2-(1-piperidinyl)ethoxy]phenyl]methanone Hydrochloride

23. [6-hydroxy-2-(4-hydroxyphenyl)-1-benzothiophen-3-yl]-[4-(2-piperidin-1-ylethoxy)phenyl]methanone;hydrochloride

24. Smr000058508

25. Raloxifene Hydrochloride [usan]

26. Ncgc00015889-05

27. Cas-82640-04-8

28. C28h27no4s.hcl

29. Loxifen

30. Unii-4f86w47br6

31. Sr-01000076102

32. Cdt-raloxifene

33. Raloxifene-d4 Hcl

34. Raloxifene Cloridrato

35. Evista (tn)

36. Mfcd01938233

37. Prestwick_1035

38. Raloxifene Hydrochloride [usan:usp]

39. Methanone, Hydrochloride

40. Cloridrato De Raloxifeno

41. Clorhidrato De Raloxifeno

42. Chlorhydrate De Raloxifene

43. Ly139481 Hydrochloride

44. Ly156758 Hydrochloride

45. Chembl1116

46. Schembl19077

47. Mls000859902

48. Mls001332533

49. Mls001332534

50. Mls002222293

51. Raloxifene Hydrochloride, Solid

52. Evista, Raloxifene Hydrochloride

53. Raloxifene Hydrochloride- Bio-x

54. Dtxsid1034181

55. Ly156758 (keoxifene) Hcl

56. Ly-139481 Hcl

57. Hms1570n05

58. Pharmakon1600-01505622

59. Amy23426

60. Bcp05713

61. Raloxifene Hydrochloride (jan/usp)

62. Tox21_110255

63. Tox21_302369

64. Tox21_501051

65. Hy-13738a

66. Nsc706725

67. Nsc759285

68. Raloxifene Hydrochloride [mi]

69. S1227

70. Raloxifene Hydrochloride [jan]

71. Akos008131940

72. Tox21_110255_1

73. Ac-8390

74. Ccg-213497

75. Cs-1775

76. Ds-2162

77. Ks-1102

78. Lp01051

79. Nc00665

80. Nsc 706725

81. Nsc 759285

82. Nsc-759285

83. Raloxifene Hydrochloride [mart.]

84. Raloxifene Hydrochloride [vandf]

85. Ncgc00015889-03

86. Ncgc00015889-11

87. Ncgc00092353-01

88. Ncgc00092353-03

89. Ncgc00094334-01

90. Ncgc00094334-02

91. Ncgc00255153-01

92. Ncgc00261736-01

93. Raloxifene Hydrochloride [usp-rs]

94. Raloxifene Hydrochloride [who-dd]

95. Br164310

96. Methanone, (6-hydroxy-2-(4-hydroxyphenyl)benzo(b)thien-3-yl)(4-(2-(1-piperidinyl)ethoxy)phenyl)-, Hydrochloride

97. Methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl][4-[2-(1-piperidinyl)ethoxy]phenyl]-,hydrochloride (1:1)

98. Raloxifene Hydrochloride [ema Epar]

99. Eu-0101051

100. Ft-0630912

101. R0109

102. Sw197106-5

103. En300-52517

104. Raloxifene Hydrochloride [orange Book]

105. D02217

106. R 1402

107. Raloxifene Hydrochloride [ep Monograph]

108. Raloxifene Hydrochloride [usp Impurity]

109. Raloxifene Hydrochloride [usp Monograph]

110. 640r048

111. A840401

112. Q-201656

113. Sr-01000076102-2

114. Sr-01000076102-9

115. Q27122215

116. (6-oxo-1,6-dihydro-pyridazin-3-yloxy)-aceticacid

117. Raloxifene Hydrochloride, European Pharmacopoeia (ep) Reference Standard

118. Raloxifene Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

119. Raloxifene Hydrochloride, United States Pharmacopeia (usp) Reference Standard

120. (6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thiophen-3-yl)-(4-(2-(piperidin-1-yl)ethoxy)phenyl)methanone Hydrochloride

121. (6-oh-2-(4-oh-ph)benzo[b]thiophen-3-yl)(4-(2-(piperidin-1-yl)ethoxy)ph)methanone Hydrochloride

122. [6-hydroxy-2-(4-hydroxyphenyl)-1-benzothien-3-yl][4-(2-piperidin-1-ylethoxy)phenyl]methanone Hydrochloride

123. [6-hydroxy-2-(4-hydroxyphenyl)-benzo[b]thien-3-yl][4-[2-(1-piperidinyl)ethoxy]phenyl]-methanone Hydrochloride

124. [6-hydroxy-2-(4-hydroxyphenyl)benzo [b]thien-3-yl][4-[2-(1-piperidinyl)ethoxy]phenyl]-methanone Hydrochloride

125. [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl][4-[2-(1-piperidinyl)ethoxy]phenyl]-methanone Hydrochloride

126. [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl][4-[2-(1-piperidinyl)ethoxy]phenyl]-methanone, Monohydrochloride

127. [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thiophen-3-yl][4-[2-(1-piperidinyl)ethoxy]phenyl]methanone Hydrochloride

128. [6-hydroxy-2[4-hydroxyphenyl)benzo [b]thien-3-yl][4-[2-(1-piperidinyl)ethoxy]phenyl]methanone Hydrochloride

129. [6-hydroxy-2[4-hydroxyphenyl)benzo [b]thien3-yl][4-[2-(1-piperidinyl)ethoxy]phenyl]methanone Hydrochloride

130. [6-hydroxy-2[4-hydroxyphenyl)benzo[b]thien-3-yl][4-[2-(1-piperidinyl)ethoxy]phenyl]methanone Hydrochloride

131. 1-[2-(4-{[6-hydroxy-2-(4-hydroxyphenyl)-1-benzothiophen-3-yl]carbonyl}phenoxy)ethyl]piperidinium Chloride

132. 6-hydroxy-2-(4-hydroxyphenyl)-3-[ 4-(2-piperidinoethoxy)benzoyl]benzo[b]thiophene, Hydrochloride

133. 6-hydroxy-2-(4-hydroxyphenyl)-3-[4-(2-piperidinoethoxy)benzoyl]-benzo[b]-thiophene Hydrochloride

134. 6-hydroxy-2-(4-hydroxyphenyl)-3-[4-(2-piperidinoethoxy)benzoyl]-benzo[b]thiophene Hydrochloride

135. 6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl 4-[2-(1-piperidinyl)ethoxy]phenyl Methanone Hydrochloride

136. 6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thiophen-3-yl 4-[2-(1-piperidinyl)ethoxy]phenyl Ketone Hydrochloride

137. 6-hydroxy-2-(p-hydroxyphenyl)benzo(.beta.)thien-3-yl-p-(2-piperidinoethoxy)phenyl Ketone, Hydrochloride

138. Methanone, (6-hydroxy-2-(4-hydroxyphenyl)benzo(.beta.)thien-3-yl)(4-(2-(1-piperidinyl)ethoxy)phenyl)-, Hydrochloride

139. Methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl][4-[2-(1-piperidinyl)ethoxy]phenyl]-, Hydrochloride (1:1)

140. Raloxifene Hydrochloride For Peak Identification, European Pharmacopoeia (ep) Reference Standard

2.4 Create Date

2005-03-26

3 Chemical and Physical Properties

Molecular Formula	C₂₈H₂₈ClNO₄S
Molecular Weight	510.0 g/mol
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	6
Rotatable Bond Count	7
Exact Mass	509.1427572 g/mol
Monoisotopic Mass	509.1427572 g/mol
Topological Polar Surface Area	98.2 Å²
Heavy Atom Count	35
Formal Charge	0
Complexity	655
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Evista
PubMed Health	Raloxifene (By mouth)
Drug Classes	Antineoplastic Agent, Endocrine-Metabolic Agent
Drug Label	EVISTA (raloxifene hydrochloride) is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is:The chemical designation is m...
Active Ingredient	Raloxifene hydrochloride
Dosage Form	Tablet
Route	oral; Oral
Strength	60mg
Market Status	Prescription
Company	Lilly

2 of 4
Drug Name	Raloxifene hydrochloride
Drug Label	EVISTA (raloxifene hydrochloride) is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is:The chemical designation is m...
Active Ingredient	Raloxifene hydrochloride
Dosage Form	Tablet
Route	oral; Oral
Strength	60mg
Market Status	Tentative Approval; Prescription
Company	Teva Pharms Usa; Invagen Pharms; Watson Labs

3 of 4
Drug Name	Evista
PubMed Health	Raloxifene (By mouth)
Drug Classes	Antineoplastic Agent, Endocrine-Metabolic Agent
Drug Label	EVISTA (raloxifene hydrochloride) is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is:The chemical designation is m...
Active Ingredient	Raloxifene hydrochloride
Dosage Form	Tablet
Route	oral; Oral
Strength	60mg
Market Status	Prescription
Company	Lilly

4 of 4
Drug Name	Raloxifene hydrochloride
Drug Label	EVISTA (raloxifene hydrochloride) is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is:The chemical designation is m...
Active Ingredient	Raloxifene hydrochloride
Dosage Form	Tablet
Route	oral; Oral
Strength	60mg
Market Status	Tentative Approval; Prescription
Company	Teva Pharms Usa; Invagen Pharms; Watson Labs

4.2 Drug Indication

Optruma is indicated for the treatment and prevention of osteoporosis in post-menopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining the choice of Optruma or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5. 1).

Evista is indicated for the treatment and prevention of osteoporosis in post-menopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining the choice of Evista or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits.

Raloxifene is indicated for the treatment and prevention of osteoporosis in postmenopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.

When determining the choice of raloxifene or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits.

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

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.)

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.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Selective Estrogen Receptor Modulators [MoA]; Estrogen Agonist/Antagonist [EPC]

5.3 ATC Code

G03XC01

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API Reference Price

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REDDY\\'S LABORATORIES","supplierCountry":"INDIA","foreign_port":"TOKYO - HANEDA","customer":"BUSHU PHARMACEUTICALS LTD","customerCountry":"JAPAN","quantity":"201.74","actualQuantity":"201.74","unit":"KGS","unitRateFc":"890","totalValueFC":"175709","currency":"USD","unitRateINR":72732.161594131059,"date":"02-Apr-2024","totalValueINR":"14672986.28","totalValueInUsd":"175709","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"8846877","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE, HYDERABAD ANDHRA PRADESH","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712860200,"product":"RALOXIFENE HYDROCHLORIDE","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"DR. REDDY\\'S LABORATORIES","supplierCountry":"INDIA","foreign_port":"BEIJING","customer":"SHENZHEN SUNGENING MEDICINE ","customerCountry":"CHINA","quantity":"60.00","actualQuantity":"60","unit":"KGS","unitRateFc":"1500","totalValueFC":"88805.9","currency":"USD","unitRateINR":123599.0745,"date":"12-Apr-2024","totalValueINR":"7415944.47","totalValueInUsd":"88805.9","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"9080583","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE, HYDERABAD ANDHRA PRADESH","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718130600,"product":"RALOXIFENE HYDROCHLORIDE","address":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower","city":"Hyderabad","supplier":"APITORIA PHARMA PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"ATHENS","customer":"PHARMATHEN SA","customerCountry":"GREECE","quantity":"9.00","actualQuantity":"9","unit":"KGS","unitRateFc":"920","totalValueFC":"8094.1","currency":"USD","unitRateINR":75076.953333333324,"date":"12-Jun-2024","totalValueINR":"675692.58","totalValueInUsd":"8094.1","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"1602752","productDescription":"API","marketType":"REGULATED MARKET","country":"GREECE","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower, Hyderabad","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719513000,"product":"RALOXIFENE HYDROCHLORIDE","address":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower","city":"Hyderabad","supplier":"APITORIA PHARMA PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"ATHENS","customer":"PHARMATHEN SA","customerCountry":"GREECE","quantity":"173.15","actualQuantity":"173.15","unit":"KGS","unitRateFc":"920","totalValueFC":"156470.5","currency":"USD","unitRateINR":75437.879295408609,"date":"28-Jun-2024","totalValueINR":"13062068.8","totalValueInUsd":"156470.5","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"2028411","productDescription":"API","marketType":"REGULATED MARKET","country":"GREECE","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower, Hyderabad","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721154600,"product":"RALOXIFENE HYDROCHLORIDE USP","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"DR. REDDY\\'S LABORATORIES","supplierCountry":"INDIA","foreign_port":"MEXICO CITY","customer":"INVESTIGACION FARMACEUTICA, S.A. DE","customerCountry":"MEXICO","quantity":"100.00","actualQuantity":"99.996","unit":"KGS","unitRateFc":"1300","totalValueFC":"127721.2","currency":"USD","unitRateINR":106767.77091083644,"date":"17-Jul-2024","totalValueINR":"10676350.02","totalValueInUsd":"127721.2","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"2474520","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE, HYDERABAD ANDHRA PRADESH","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725042600,"product":"RALOXIFENE HYDROCHLORIDE USP","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"DR. REDDY\\'S LABORATORIES","supplierCountry":"INDIA","foreign_port":"PHILADELPHIA METROP","customer":"INVAGEN PHARMACEUTICALS INC","customerCountry":"UNITED STATES","quantity":"169.70","actualQuantity":"169.7","unit":"KGS","unitRateFc":"526.5","totalValueFC":"86147.6","currency":"USD","unitRateINR":42580.655509723045,"date":"31-Aug-2024","totalValueINR":"7225937.24","totalValueInUsd":"86147.6","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"3633024","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE, HYDERABAD ANDHRA PRADESH","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730399400,"product":"RALOXIFENE HYDROCHLORIDE USP","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"DR. REDDY\\'S LABORATORIES","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. K","customer":"SCIEGEN PHARMACEUTICALS","customerCountry":"UNITED STATES","quantity":"223.17","actualQuantity":"223.17","unit":"KGS","unitRateFc":"495","totalValueFC":"106353","currency":"USD","unitRateINR":40215.708114889996,"date":"01-Nov-2024","totalValueINR":"8974939.58","totalValueInUsd":"106353","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"5321489","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE, HYDERABAD ANDHRA PRADESH","customerAddress":""}]

Number of Transactions

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WATSON LABS INC

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APOTEX INC

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Strides Pharma Science Pty Ltd

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raloxifene

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Strides Pharma Science Pty Ltd

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raloxifene

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Arrow Pharma Pty Ltd

Australia

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Generic Health Pty Ltd

Australia

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ABOUT THIS PAGE

Raloxifene Hydrochloride Manufacturers

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

Raloxifene Hydrochloride Suppliers

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

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

Raloxifene Hydrochloride USDMF

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

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

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

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

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

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

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

Raloxifene Hydrochloride CEP

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

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

Raloxifene Hydrochloride WC

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

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

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

Finished drug products

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

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

Raloxifene Hydrochloride GMP

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

Raloxifene Hydrochloride CoA

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

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

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