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Chemistry

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Also known as: 112809-51-5, Femara, 4,4'-((1h-1,2,4-triazol-1-yl)methylene)dibenzonitrile, Letrozol, Cgs 20267, Cgs-20267

Molecular Formula

C₁₇H₁₁N₅

Molecular Weight

285.30 g/mol

InChI Key

HPJKCIUCZWXJDR-UHFFFAOYSA-N

FDA UNII

7LKK855W8I

A triazole and benzonitrile derivative that is a selective non-steroidal aromatase inhibitor, similar to ANASTROZOLE. It is used in the treatment of metastatic or locally advanced breast cancer in postmenopausal women.

Letrozole is an Aromatase Inhibitor. The mechanism of action of letrozole is as an Aromatase Inhibitor.

1 2D Structure

Letrozole

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

4-[(4-cyanophenyl)-(1,2,4-triazol-1-yl)methyl]benzonitrile

2.1.2 InChI

InChI=1S/C17H11N5/c18-9-13-1-5-15(6-2-13)17(22-12-20-11-21-22)16-7-3-14(10-19)4-8-16/h1-8,11-12,17H

2.1.3 InChI Key

HPJKCIUCZWXJDR-UHFFFAOYSA-N

2.1.4 Canonical SMILES

C1=CC(=CC=C1C#N)C(C2=CC=C(C=C2)C#N)N3C=NC=N3

2.2 Other Identifiers

2.2.1 UNII

7LKK855W8I

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 4,4'-(1h-1,2,4-triazol-1-yl-methylene)-bis(benzonitrile)

2. Cgs 20267

3. Cgs-20267

4. Cgs20267

5. Fmara

6. Femara

2.3.2 Depositor-Supplied Synonyms

1. 112809-51-5

2. Femara

3. 4,4'-((1h-1,2,4-triazol-1-yl)methylene)dibenzonitrile

4. Letrozol

5. Cgs 20267

6. Cgs-20267

7. 4-[(4-cyanophenyl)-(1,2,4-triazol-1-yl)methyl]benzonitrile

8. 4,4'-(1h-1,2,4-triazol-1-ylmethylene)dibenzonitrile

9. Letrazole

10. Benzonitrile, 4,4'-(1h-1,2,4-triazol-1-ylmethylene)bis-

11. Femera

12. 4,4'-(1h-1,2,4-triazol-1-ylmethanediyl)dibenzonitrile

13. 4,4'-(1h-1,2,4-triazol-1-ylmethylene)bisbenzonitrile

14. Nsc-759652

15. Chembl1444

16. 4-[(4-cyanophenyl)(1h-1,2,4-triazol-1-yl)methyl]benzonitrile

17. 4,4'-(1h-1,2,4-triazol-1-ylmethylene)bis-benzonitrile

18. 7lkk855w8i

19. Chebi:6413

20. 4,4'-(1h-1,2,4-triazol-1-ylmethylene) Bis-benzonitrile

21. Ncgc00016973-01

22. Letoval

23. Cas-112809-51-5

24. Dsstox_cid_3202

25. Dsstox_rid_76924

26. Dsstox_gsid_23202

27. Smr000466343

28. Femara (tn)

29. Hsdb 7461

30. Sr-01000759382

31. Letrozole (jan/usp/inn)

32. Unii-7lkk855w8i

33. Ccris 8822

34. 1-[bis(4-cyanophenyl)methyl]-1,2,4-triazole

35. Fem-345

36. Femara, Letrozole

37. Letrozole [usan:usp:inn:ban]

38. Letrozole- Bio-x

39. Cgs20267

40. Mfcd00866241

41. Letrozole [inn]

42. Letrozole [jan]

43. Letrozole [mi]

44. Letrozole [hsdb]

45. Letrozole [usan]

46. Prestwick0_001025

47. Prestwick1_001025

48. Prestwick2_001025

49. Prestwick3_001025

50. Femara (tn) (novartis)

51. Letrozole [mart.]

52. Letrozole [usp-rs]

53. Letrozole [who-dd]

54. Schembl4331

55. 1-[bis-(4-cyanophenyl)methyl]-1,2,4-triazole

56. Bidd:pxr0130

57. Bspbio_001209

58. Mls000759455

59. Mls001424038

60. Mls002584991

61. Mls006010040

62. Bidd:gt0015

63. Spbio_003070

64. Bpbio1_001331

65. Gtpl5209

66. Letrozole [ep Impurity]

67. Letrozole [orange Book]

68. Dtxsid4023202

69. Letrozole [ep Monograph]

70. Letrozole, >=98% (hplc)

71. Bdbm13061

72. Ex-a965

73. Letrozole [usp Monograph]

74. Hms1571m11

75. Hms2051e08

76. Hms2089l22

77. Hms2098m11

78. Hms2233c23

79. Hms3369e11

80. Hms3393e08

81. Hms3651k05

82. Hms3715m11

83. Pharmakon1600-01502354

84. Amy32541

85. Bcp23354

86. Zinc3778874

87. Tox21_110719

88. Tox21_303572

89. Nsc719345

90. Nsc759652

91. S1235

92. Stl451047

93. Akos005145822

94. Ab07525

95. Ac-1193

96. Bcp9000848

97. Ccg-100849

98. Cs-1776

99. Db01006

100. Ks-1269

101. Nc00099

102. Nsc 759652

103. Nsc-719345

104. Ncgc00016973-02

105. Ncgc00016973-03

106. Ncgc00016973-06

107. Ncgc00257460-01

108. Bl164620

109. Hy-14248

110. Bcp0726000213

111. 1-bis(4-cyanophenyl)methyl-1,2,4-triazole

112. 4,2,4-triazol-1-ylmethylene)dibenzonitrile

113. Ab00514009

114. L0248

115. Sw197294-4

116. A25380

117. C08163

118. D00964

119. Ab00514009-05

120. Ab00514009-07

121. Ab00514009-08

122. Ab00514009-09

123. Ab00514009_10

124. Ab00514009_11

125. 809l515

126. Kisqali Femara Co-pack Component Letrozole

127. Q194974

128. W-60273

129. 4,4'-(1,2,4-triazol-1-ylmethylene)dibenzonitrile

130. Letrozole Component Of Kisqali Femara Co-pack

131. Q-201291

132. Sr-01000759382-4

133. Sr-01000759382-5

134. Brd-k88789588-001-03-2

135. 4,4 -(1h-1,2,4-triazol-1-ylmethanediyl)dibenzonitrile

136. 4,4'-(1h-1,2,4-triazol-1-ylmethylene)-bisbenzonitrile

137. F2173-0288

138. Z1741968261

139. 4,4'-((1h-1,2,4-triazol-1-yl)-methylene)dibenzonitrile

140. Letrozole, European Pharmacopoeia (ep) Reference Standard

141. Letrozole, United States Pharmacopeia (usp) Reference Standard

142. 4-[1-(4-cyanophenyl)-1-(1,2,4-triazol-1-yl)methyl]benzonitrile

143. Letrozole, Pharmaceutical Secondary Standard; Certified Reference Material

2.4 Create Date

2005-03-25

3 Chemical and Physical Properties

Molecular Formula	C₁₇H₁₁N₅
Molecular Weight	285.30 g/mol
XLogP3	2.7
Hydrogen Bond Donor Count	0
Hydrogen Bond Acceptor Count	4
Rotatable Bond Count	3
Exact Mass	285.10144537 g/mol
Monoisotopic Mass	285.10144537 g/mol
Topological Polar Surface Area	78.3 Å²
Heavy Atom Count	22
Formal Charge	0
Complexity	420
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	1

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Femara
PubMed Health	Letrozole (By mouth)
Drug Classes	Antineoplastic Agent, Endocrine-Metabolic Agent
Drug Label	Femara tablets for oral administration contains 2.5 mg of letrozole, a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). It is chemically described as 4,4'-(1H-1,2,4-Triazol-1-ylmethylene)dibenzonitrile, and its structural formula i
Active Ingredient	Letrozole
Dosage Form	Tablet
Route	Oral
Strength	2.5mg
Market Status	Prescription
Company	Novartis Pharms

2 of 4
Drug Name	Letrozole
PubMed Health	Letrozole (By mouth)
Drug Classes	Antineoplastic Agent, Endocrine-Metabolic Agent
Drug Label	Letrozole tablets USP for oral administration contain 2.5 mg of letrozole, a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). It is chemically described as 4,4'-(1H-1,2,4-triazol-1-ylmethylene)dibenzonitrile, and its structural for
Active Ingredient	Letrozole
Dosage Form	Tablet
Route	oral; Oral
Strength	2.5mg
Market Status	Tentative Approval; Prescription
Company	Vintage Pharms; Fresenius Kabi Oncol; Apotex; Accord Hlthcare; Jiangsu Hengrui Med; Indicus Pharma; Natco Pharma; Sun Pharm Inds; Roxane; Teva Pharms; Kudco Ireland; Zydus Pharms Usa; Dr Reddys Labs; Mylan; Impax Labs

3 of 4
Drug Name	Femara
PubMed Health	Letrozole (By mouth)
Drug Classes	Antineoplastic Agent, Endocrine-Metabolic Agent
Drug Label	Femara tablets for oral administration contains 2.5 mg of letrozole, a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). It is chemically described as 4,4'-(1H-1,2,4-Triazol-1-ylmethylene)dibenzonitrile, and its structural formula i
Active Ingredient	Letrozole
Dosage Form	Tablet
Route	Oral
Strength	2.5mg
Market Status	Prescription
Company	Novartis Pharms

4 of 4
Drug Name	Letrozole
PubMed Health	Letrozole (By mouth)
Drug Classes	Antineoplastic Agent, Endocrine-Metabolic Agent
Drug Label	Letrozole tablets USP for oral administration contain 2.5 mg of letrozole, a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). It is chemically described as 4,4'-(1H-1,2,4-triazol-1-ylmethylene)dibenzonitrile, and its structural for
Active Ingredient	Letrozole
Dosage Form	Tablet
Route	oral; Oral
Strength	2.5mg
Market Status	Tentative Approval; Prescription
Company	Vintage Pharms; Fresenius Kabi Oncol; Apotex; Accord Hlthcare; Jiangsu Hengrui Med; Indicus Pharma; Natco Pharma; Sun Pharm Inds; Roxane; Teva Pharms; Kudco Ireland; Zydus Pharms Usa; Dr Reddys Labs; Mylan; Impax Labs

4.2 Therapeutic Uses

Antineoplastic

O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th Edition, Whitehouse Station, NJ: Merck and Co., Inc., 2001., p. 974

Letrozole is indicated for first-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. Letrozole is also indicated for treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy. /Included in US product label/

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 1902

4.3 Drug Warning

A 37-year-old premenopausal woman with relapsed breast cancer (BC) in the right supraclavicular nodes, after failed treatment with the combination luteinizing hormone releasing hormone-a (LHRHa; triptorelin) plus tamoxifen, was started on triptorelin 3.75 mg every 28 days plus letrozole 2.5 mg daily. Approximately 6 months after starting this therapy, she complained of a daily scalp hair loss while combing and progressively developed a diffuse non-scarring alopecia on her crown. There were no signs of virilization ... She was not taking any other drug. Hematological parameters were normal. Blood examination ruled out pituitary or thyroid problems. There were no other possible causes that could induce alopecia, such as lupus erythematosus, HIV infection, secondary syphilis, or deficiencies of protein, iron, biotin or zinc.

PMID:14581280 Carlini P et al; Ann Oncol 14 (11): 1689-90 (2003)

In patients receiving letrozole as first-line therapy, bone pain, back pain, and limb pain occurred in 22, 18, and 10% of patients, respectively. In patients receiving letrozole as second-line therapy, adverse musculoskeletal effects (including musculoskeletal pain, skeletal pain, back pain, arm pain, and leg pain) were reported in 21% and fracture was reported in less than 5% of patients. Arthralgia was reported in 16% of patients receiving letrozole as first-line therapy and in 8% of patients receiving the drug as second-line therapy. Hypercalcemia occurred in less than 5% of patients receiving letrozole as second-line therapy.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 1114

Adverse musculoskeletal effects have been reported in patients receiving letrozole as adjuvant therapy for early-stage breast cancer in clinical trials. In a double-blind, randomized trial in postmenopausal women with hormone receptor-positive breast cancer who had received approximately 5 years of tamoxifen adjuvant therapy following primary treatment for early breast cancer, extended adjuvant therapy with letrozole was associated with an increased incidence of arthritis, arthralgia, and myalgia, and a trend toward higher rates of newly diagnosed osteoporosis and bone fracture compared with placebo therapy.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 1114

All women receiving adjuvant therapy with letrozole should be advised to adopt lifestyle changes (eg, weight-bearing exercise, abstinence from smoking, moderation in alcohol consumption) and dietary supplementation with calcium and vitamin D to reduce the risk of osteoporosis.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 1114

For more Drug Warnings (Complete) data for LETROZOLE (26 total), please visit the HSDB record page.

4.4 Drug Indication

Letrozole is indicated to treat postmenopausal women with hormone receptor (HR) positive early breast cancer, postmenopausal women with early breast cancer who have periviously been treated with tamoxifen, and postmenopausal women with HR+ or unknown advanced breast cancer. Letrozole, given with ribociclib, is indicated to treat pre, peri, and postmenopausal women with HR+ and human epidermal growth factor 2 (HER2) negative advanced or metastatic breast cancer.

FDA Label

5 Pharmacology and Biochemistry

5.1 Pharmacology

Letrozole is an aromatase inhibitor used in the treatment of breast cancer. Aromatase inhibitors work by inhibiting the action of the enzyme aromatase, which converts androgens into estrogens by a process called aromatization. As breast tissue is stimulated by estrogens, decreasing their production is a way of suppressing recurrence of the breast tumor tissue. Letrozole is a third generation type II aromatase inhibitor used to treat estrogen dependant breast cancers. It has a long duration of action as it has a half life of over 42 hours in breast cancer patients. Patients should be counselled regarding the risk of interstitial lung disease, pneumonitis, QT prolongation, elevated transaminase levels, neutropenia, and embryo-fetal toxicity.

5.2 MeSH Pharmacological Classification

Antineoplastic Agents

Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)

Aromatase Inhibitors

Compounds that inhibit AROMATASE in order to reduce production of estrogenic steroid hormones. (See all compounds classified as Aromatase Inhibitors.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

LETROZOLE

5.3.2 FDA UNII

7LKK855W8I

5.3.3 Pharmacological Classes

Aromatase Inhibitors [MoA]; Aromatase Inhibitor [EPC]

5.4 ATC Code

L02BG04

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

L - Antineoplastic and immunomodulating agents

L02 - Endocrine therapy

L02B - Hormone antagonists and related agents

L02BG - Aromatase inhibitors

L02BG04 - Letrozole

5.5 Absorption, Distribution and Excretion

Absorption

Letrozole is 99.9% orally bioavailable. A 2.5mg oral dose reaches a C_max of 104nmol/L with a T_max of 8.10h, and an AUC of 7387nmol\*h/L.

Route of Elimination

Letrozole is 90% eliminated in the urine. 75% of the dose is recovered as a glucuronide metabolite, 9% is in the form of the ketone and carbinol metabolites, and 6% is recovered in urine as unchanged letrozole.

Volume of Distribution

The volume of distribution of letrozole is 1.87L/kg.

Clearance

The average clearance after a single dose of letrozole was 1.52L/h and at steady state was 1.20L/h.

Letrozole is rapidly and completely absorbed from the GI tract following oral administration. Steady-state plasma concentrations of the drug are reached in 2-6 weeks in patients receiving letrozole 2.5 mg daily. Letrozole exhibits slightly nonlinear pharmacokinetics with repeated administration of 2.5 mg daily, with steady-state plasma concentrations 1.5-2 times higher than predicted based on plasma concentrations measured after a single dose. However, continuous accumulation of letrozole does not occur, and steady-state concentrations are maintained over extended periods of daily drug administration. Food does not affect the oral absorption of the drug.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 1116

Letrozole has a large volume of distribution of approximately 1.9 L/kg. Letrozole is weakly bound to plasma proteins.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 1116

Following oral administration of radiolabeled letrozole, 90% of the administered dose was excreted in the urine. Of the radiolabeled drug recovered in urine, at least 75% was the glucuronide of the carbinol metabolite, about 9% consisted of 2 unidentified metabolites, and 6% was unchanged drug.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 1116

It is not known whether letrozole is distributed into human breast milk.

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 1902

For more Absorption, Distribution and Excretion (Complete) data for LETROZOLE (6 total), please visit the HSDB record page.

5.6 Metabolism/Metabolites

Letrozole is metabolized by CYP2A6 to a ketone analog metabolite, which is further metabolized by CYP3A4 and CYP2A6 to 4,4'-(hydroxymethylene)dibenzonitrile. 4,4'-(hydroxymethylene)dibenzonitrile is glucuronidated by UGT2B7.

The primary elimination pathway of letrozole consists of slow metabolism in the liver to a pharmacologically inactive carbinol metabolite (4,4'-methanol-bisbenzonitrile) followed by renal excretion of the glucuronide conjugate of this metabolite. Formation of the carbinol metabolite is mediated by cytochrome P-450 (CYP) isoenzymes 3A4 and 2A6, and formation of the ketone analog of the carbinol metabolite is mediated by isoenzyme 2A6.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 1116

5.7 Biological Half-Life

The terminal elimination half life of letrozole is approximately 42h in healthy volunteers, but longer in breast cancer patients.

Letrozole has a terminal elimination half-life of about 2 days.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 1116

5.8 Mechanism of Action

Letrozole is a non-steroidal type II aromatase inhibitor. It blocks the active site, and therefore the electron transfer chain of CYP19A1. This competitive inhibition prevents the conversion of androgens to estrogen. This action leads to a reduction in uterine weight and elevated leuteinizing hormone. In postmenopausal women, the action of aromatase is responsible for the majority of estrogen production. With reduced availability of estrogen, estrogen-dependant tumors regress. Third generation aromatase inhibitors do not significantly affect cortisol, aldosterone, and thyroxine levels.

Letrozole is a nonsteroidal competitive inhibitor of the aromatase enzyme system; it inhibits the conversion of androgens to estrogens. In adult nontumor- and tumor-bearing female animals, letrozole is as effective as ovariectomy in reducing uterine weight, elevating serum LH, and causing the regression of estrogen-dependent tumors. In contrast to ovariectomy, treatment with letrozole does not lead to an increase in serum FSH. Letrozole selectively inhibits gonadal steroidogenesis but has no significant effect on adrenal mineralocorticoid or glucocorticoid synthesis. Letrozole inhibits the aromatase enzyme by competitively binding to the heme of the cytochrome P450 subunit of the enzyme, resulting in a reduction of estrogen biosynthesis in all tissues. Treatment of women with letrozole significantly lowers serum estrone, estradiol and estrone sulfate and has not been shown to significantly affect adrenal corticosteroid synthesis, aldosterone synthesis, or synthesis of thyroid hormones.

Physicians Desk Reference 60th ed, Thomson PDR, Montvale, NJ 2006., p. 2210

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DMF Number : 21182

Submission : 2007-12-21

Status : Active

Type : II

Corporate PDF

02

Teva Pharmaceutical Industries Ltd

Ireland

Pharma, Lab & Chemical Expo

Not Confirmed

03

Alcami Wisconsin Corp

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

04

Cipla Ltd

India

India

Pharma, Lab & Chemical Expo

Not Confirmed

08

Scinopharm Taiwan Ltd

Taiwan

Pharma, Lab & Chemical Expo

Not Confirmed

09

Tai Heng Industry Co Ltd

China

Pharma, Lab & Chemical Expo

Not Confirmed

10

Zhejiang Hisun Pharmaceutical Co Ltd

China

Pharma, Lab & Chemical Expo

Not Confirmed

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

CEP/COS

01

TEVA PHARMACEUTICAL INDUSTRIES LTD ...

Israel

CPhI WW Frankfurt

Booth #6.1A32

TAPI offers customized CDMO Solutions for API development and manufacturing services.

Contact Supplier

Israel

Virtual Booth

Digital Content

Letrozole

Certificate Number : CEP 2022-209 - Rev 00

Status : Valid

Issue Date : 2024-03-18

Type : Chemical

Substance Number : 2334

Corporate PDF

02

APOTEX PHARMACHEM INDIA PVT. LTD Ba...

Canada

Pharma, Lab & Chemical Expo

Not Confirmed

03

CIPLA LIMITED Mumbai IN

India

Pharma, Lab & Chemical Expo

Not Confirmed

04

MAC CHEM PRODUCTS (INDIA) PVT. LTD....

Pharma, Lab & Chemical Expo

Not Confirmed

Only 10 entries up to this point, click to access all

India

Pharma, Lab & Chemical Expo

Not Confirmed

08

Dr. Reddy's Laboratories Ltd.

Gabon

Pharma, Lab & Chemical Expo

Not Confirmed

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

EU WC

01

Dr. Reddy's Laboratories

India

CPhI WW Frankfurt

Booth #9.1B48

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Contact Supplier

India

Virtual Booth

Digital Content

Letrozole USP/EP

Date of Issue : 2022-06-17

Valid Till : 2025-07-07

Written Confirmation Number : WC-0067

Address of the Firm : Chemical Technical Operations Unit-VI, APIIC Industrial Estate, Pydibhimavaram V...

Product Web Link

02

Cipla

India

Pharma, Lab & Chemical Expo

Not Confirmed

03

Fresenius Kabi Oncology Limited

India

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

Only 10 entries up to this point, click to access all

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

KDMF

01

Axplora

Germany

Pharma, Lab & Chemical Expo

Not Confirmed

Axplora- The partner of choice for complex APIs.

Contact Supplier

Germany

Virtual Booth

Digital Content

Letrozole

Registrant Name : Novartis Korea Ltd.

Registration Date : 2021-09-10

Registration Number : 20210910-209-J-1104

Manufacturer Name : FINORGA SAS@Jetpharma SA

Manufacturer Address : route de Givors Chasse Sur Rhone,38670, France@Via Sottobisio 42A, 6828 Balerna,Switz...

Product Web Link

02

JARI Pharmaceutical

China

South Korea

Pharma, Lab & Chemical Expo

Not Confirmed

08

Sicor de Mexico

Mexico

Pharma, Lab & Chemical Expo

Not Confirmed

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

NDC API

01

Dr.Reddy's Laboratories Limited

India

CPhI WW Frankfurt

Booth #9.1B48

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Contact Supplier

India

Virtual Booth

Digital Content

LETROZOLE

NDC Package Code : 55111-809

Start Marketing Date : 2007-11-13

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

Product Web Link

02

Catalent Micron Technologies, Inc.

U.S.A

India

Pharma, Lab & Chemical Expo

Not Confirmed

10

Zhejiang Hisun Pharmaceutical Co., ...

China

Pharma, Lab & Chemical Expo

Not Confirmed

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Listed Suppliers

01

LGM Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

Contact Supplier

U.S.A

Virtual Booth

Digital Content

Letrozole

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.

02

Jai Radhe Sales

India

Pharma, Lab & Chemical Expo

Not Confirmed

Jai Radhe Sales is your partner for all your sourcing needs.

Contact Supplier

India

Virtual Booth

Digital Content

Letrozole

About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...

Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete sourcing solutions for pharmaceutical products from India, including technical and regulatory assistance. It believes in providing its customers with high-quality products at reasonable prices. It has always endeavored to achieve global standards in the field of pharmaceuticals and has carved out a niche for itself through new methods based on current market needs. Today, it has established itself as a truly global company, with exports to almost every continent.

03

Tofigh Daru

Iran

Pharma, Lab & Chemical Expo

Not Confirmed

Tofigh Daru develops & synthesizes a diverse range of APIs in Anticancer, Narcotics, Cardiovascular to Immunomodulatory Segments.

Contact Supplier

Iran

Virtual Booth

Digital Content

Letrozole

About the Company : Tofigh Daru (TODACO) belongs to the Tamin Pharmaceutical Investment Company, the biggest pharmaceutical holding in Iran. TODACO develops novel APIs in therapeutic categories like A...

Tofigh Daru (TODACO) belongs to the Tamin Pharmaceutical Investment Company, the biggest pharmaceutical holding in Iran. TODACO develops novel APIs in therapeutic categories like Anti-cancer, Anti-diabetics, Cardiovascular & Narcotics. Today, we boast to be the one & only producer of specialized APIs like Glatiramer, Fentanyl, Remifentanil, Atracurium, and peptides including long-acting Triptorelin and we have 5 PIC/s GMP-approved production lines. We also produce semi-finished products, granules for hazardous substances & FDF know-how, tech transfers & CTD compilations. We are exporting our products to Turkey, Bulgaria, Russia, & Algeria.

04

TAPI Technology & API Services

Israel

CPhI WW Frankfurt

Booth #6.1A32

TAPI offers customized CDMO Solutions for API development and manufacturing services.

Contact Supplier

Israel

Virtual Booth

Digital Content

Letrozole

About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...

Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.

Corporate PDF

05

Biesterfeld Spezialchemie GmbH

Germany

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

Only 10 entries up to this point, click to access all

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

API Reference Price

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","customerCountry":"EGYPT","quantity":"7.00","actualQuantity":"7","unit":"KGS","unitRateFc":"4950","totalValueFC":"34560.5","currency":"USD","unitRateINR":367571.42857142858,"date":"29-Apr-2021","totalValueINR":"2573000","totalValueInUsd":"34560.5","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"1453338","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"HETERO HOUSE,H.NO.8-3-166\/7\/1ERRAGADDA, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"LETROZOLE","year":"2021","qtr":"Q2","strtotime":1621621800,"product":"LETROZOLE PH. 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AB","customerCountry":"INDIA","quantity":"0.11","actualQuantity":"0.11","unit":"KGS","unitRateFc":"10049.5","totalValueFC":"1215.5","currency":"CHF","unitRateINR":"804458.8","date":"30-Mar-2021","totalValueINR":"88490.47","totalValueInUsd":"1215.5","indian_port":"BANGALORE AIR","hs_no":"29339990","bill_no":"3346754","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"BASLE","supplierAddress":"","customerAddress":"34TH KM TUMKUR ROAD,TEPPADA BEGUR NELAMANGALA"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691346600,"product":"LETROZOLE QTY:1 X 200 MG, VALUE: USD 265 FOC","address":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,TURKAPALLY-V SHAMIRPET","city":"HYDERABAD","supplier":"UNITED STATES PHARMACOPEIAL ","supplierCountry":"CHINA","foreign_port":"NA","customer":"UNITED STATES PHARMACOPEIA ","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"0.01","unit":"KGS","unitRateFc":"1325000","totalValueFC":"274.9","currency":"USD","unitRateINR":"2254408.6","date":"07-Aug-2023","totalValueINR":"22771.804","totalValueInUsd":"274.9","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,TURKAPALLY-V SHAMIRPET"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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Drugs in Development

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Related Excipient Companies

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Excipients by Applications

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Fillers, Diluents & Binders

01

Rochem International Inc

U.S.A

Suppliers Night Expo

Attending

Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

Dosage Form : Tablet

Grade : Oral

Category : Fillers, Diluents & Binders, Taste Masking

Brand Name : Mannitol

Application : Fillers, Diluents & Binders, Taste Masking

Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

02

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Tablet

Grade : Oral

Category : Direct Compression, Fillers, Diluents & Binders, Taste Masking

Brand Name : Mannogem® XL Opal

Application : Direct Compression, Fillers, Diluents & Binders, Taste Masking

Excipient Details : Mannogem® XL Opal, directly compressible 160 µm spray-dried mannitol provides superior binding properties and tabletability.

Pharmacopoeia Ref : NA

Technical Specs : 160 µm Powder Mannitol

Ingredient(s) : Mannitol

03

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Category : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Brand Name : Pharmaburst 500

Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Excipient Details : Pharmaburst® 500 is a directly compressible pharmaceutical excipient used to create orally disintegrating tablets quickly and easily.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

04

Faran Shimi Pharmaceutical

Iran

Pharma, Lab & Chemical Expo

Not Confirmed

Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Dosage Form : Tablet

Grade : Oral

Category : Co-Processed Excipients

Brand Name : Mannitol

Application : Co-Processed Excipients

Excipient Details : Mannitol is a co-processed excipient with superior compactibility, lower disintegration time, and hygroscopicity.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

05

Faran Shimi Pharmaceutical

Iran

Pharma, Lab & Chemical Expo

Not Confirmed

Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Dosage Form : Tablet

Grade : Oral

Category : Fillers, Diluents & Binders

Brand Name : Lactose Monohydrate

Application : Fillers, Diluents & Binders

Excipient Details : Lactose monohydrate is widely used as a filler and diluent in solid dosage forms such as tablets.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Lactose Monohydrate

06

Faran Shimi Pharmaceutical

Iran

Pharma, Lab & Chemical Expo

Not Confirmed

Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Dosage Form : Tablet

Grade : Oral

Category : Fillers, Diluents & Binders

Brand Name : Polyvinylpyrrolidone

Application : Fillers, Diluents & Binders

Excipient Details : Polyvinylpyrrolidone is used as a low viscosity wet binder in solid dosage forms such as tablets.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Polyvinylpyrrolidone

07

Boai NKY Pharmaceuticals Ltd

China

Pharma, Lab & Chemical Expo

Not Confirmed

Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

Dosage Form : Capsule, Tablet

Grade : Oral (Pharma Grade)

Category : Fillers, Diluents & Binders

Brand Name : KoVidone® K25

Application : Fillers, Diluents & Binders

Excipient Details : KoVidone® K25 is used as a low viscosity wet binder in solid dosage forms such as capsules and tablets.

Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP

Technical Specs : NA

Ingredient(s) : Polyvinylpyrrolidone

08

Gangwal Healthcare

India

Pharma, Lab & Chemical Expo

Not Confirmed

Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

Dosage Form : Capsule, Tablet

Grade : Oral

Category : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders

Brand Name : STARLOSE®

Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders

Excipient Details : STARLOSE is used as a diluent, binder, directly compressible (DC), and co-processed excipient in tablets and capsules.

Pharmacopoeia Ref : IP/EP/USP-NF/IH

Technical Specs : NA

Ingredient(s) : Lactose Monohydrate

09

Nanjing Well Pharmaceutical

China

Pharma, Lab & Chemical Expo

Not Confirmed

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Dosage Form : Capsule, Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Solution, Tablet

Grade : Parenteral, Topical, Oral

Category : Fillers, Diluents & Binders, Film Formers & Plasticizers, Lubricants & Glidants, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical

Brand Name : Polyethylene Glycol 4000

Application : Fillers, Diluents & Binders, Film Formers & Plasticizers, Lubricants & Glidants, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical

Excipient Details : PEG 4000 is used as a thickener & suspending agent in suspension injections. It is also used as plasticizer, binder, lubricant & solubilizer.

Pharmacopoeia Ref : ChP/USP/EP/JP

Technical Specs : NA

Ingredient(s) : Polyethylene Glycol 4000

10

Pfanstiehl

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

Dosage Form : Injectable / Parenteral, Tablet

Grade : Parenteral, Oral

Category : Fillers, Diluents & Binders, Parenteral, Thickeners and Stabilizers

Brand Name : D-Mannitol

Application : Fillers, Diluents & Binders, Parenteral, Thickeners and Stabilizers

Excipient Details : D-mannitol protects proteins from denaturation & degradation. It is also used as a stabilizer in liquid formulations & as a bulking agent in tablets.

Pharmacopoeia Ref : USP, NF, EP, JP, ChP

Technical Specs : N/A

Ingredient(s) : Mannitol

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Chewable & Orodispersible Aids

Solubilizers

Parenteral

Topical

Film Formers & Plasticizers

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Emulsifying Agents

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Surfactant & Foaming Agents

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01

Brand Name : Femara

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Finished Drug Prices

01

Brand Name : Letrozole Zentiva

France

Pharma, Lab & Chemical Expo

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

France

Virtual Booth

Digital Content

RX/OTC/DISCN : Class B

Helvepharm AG

Letrozole

Dosage Form : Film-Coated Tablets

Dosage Strength : 2.5mg

Price Per Pack (Euro) : 54.89

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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02

Brand Name : LETROZOLE

India

Pharma, Lab & Chemical Expo

Not Confirmed

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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India

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RX/OTC/DISCN : DISCN

STRIDES PHARMA

Letrozole

Dosage Form : TABLET;ORAL

Dosage Strength : 2.5MG

Price Per Pack :

Published in :

Country : USA

RX/OTC/DISCN : DISCN

03

Brand Name : LETROZOLE THINKS

Japan

Pharma, Lab & Chemical Expo

Not Confirmed

Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

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Japan

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RX/OTC/DISCN :

TOWA PHARMACEUTICAL SPA

Letrozole

Dosage Form : Film-Coated Tablets

Dosage Strength : 2.5 mg

Price Per Pack (Euro) : 66.06

Published in :

Country : Italy

RX/OTC/DISCN :

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Product Web Link

04

Brand Name : Letrozole Zentiva

France

Pharma, Lab & Chemical Expo

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

France

Virtual Booth

Digital Content

RX/OTC/DISCN : Class B

Helvepharm AG

Letrozole

Dosage Form : Film-Coated Tablets

Dosage Strength : 2.5mg

Price Per Pack (Euro) : 182.09

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

Portfolio PDF

Product Web Link

05

Brand Name : LETROZOLE THINKS PHARMA

Japan

Pharma, Lab & Chemical Expo

Not Confirmed

Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

Contact Supplier

Japan

Virtual Booth

Digital Content

RX/OTC/DISCN :

TOWA PHARMACEUTICAL SPA

Letrozole

Dosage Form : Film-Coated Tablets

Dosage Strength : 2.5 mg

Price Per Pack (Euro) : 66.06

Published in :

Country : Italy

RX/OTC/DISCN :

Portfolio PDF

Product Web Link

06

Brand Name : Letrozol Accord

United Kingdom

Denmark

Pharma, Lab & Chemical Expo

Not Confirmed

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FDF DOSSIERS

LETROZOLE; RIBOCICLIB SUCCINATE

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ABOUT THIS PAGE

Letrozole Manufacturers

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

Letrozole Suppliers

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

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

Letrozole USDMF

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

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

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

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

Letrozole KDMF

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

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

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

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

Letrozole CEP

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

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

Letrozole WC

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

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

Letrozole 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 Letrozole as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Letrozole GMP

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

Letrozole CoA

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

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

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

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ACTIVE PHARMA INGREDIENTS

59 API Suppliers

23 USDMF

15 CEP/COS

7 JDMF

11 EU WC

8 KDMF

10 NDC API

41 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

15 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

212 FDF Dossiers

23 FDA Orange Book

118 Europe

21 Canada

18 Australia

8 South Africa

24 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

16 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

3 Actylis

1 Aeon Procare

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Avesta Pharma

25 BASF

2 Clariant

10 Corel Pharma Chem

7 DFE Pharma

1 Finar

8 Gangwal Chemicals

7 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

39 Kerry

3 Kima Chemical

6 Lonza Capsugel

14 Microlex e.U

2 Nomisma Healthcare

3 Novo Excipients

3 Pharmatrans-Sanaq

7 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

20 Roquette

7 Seppic

7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

12 Sigachi Industries

2 The Dow Chemical Company

1 Ulanqab Kema New Material

4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

89 Fillers, Diluents & Binders

53 Coating Systems & Additives

41 Direct Compression

32 Controlled & Modified Release

30 Disintegrants & Superdisintegrants

27 Granulation

22 Thickeners and Stabilizers

21 Co-Processed Excipients

19 Lubricants & Glidants