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1. Femring
2. Femtrace
3. Estradiol 3-acetate
4. Estradiol-3-acetate
5. 4245-41-4
6. Estradiol Acetate [usan]
7. E3a
8. 5r97f5h93p
9. Estradiol Acetate (usan)
10. Dsstox_cid_25867
11. Dsstox_rid_81186
12. Dsstox_gsid_45867
13. [(8r,9s,13s,14s,17s)-17-hydroxy-13-methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthren-3-yl] Acetate
14. Menoring
15. Cas-4245-41-4
16. 3-o-acetylestradiol
17. Estradiol, 3-acetate
18. 17beta-estradiol 3-acetate
19. Unii-5r97f5h93p
20. E 3a
21. Estradiol-acetate
22. Femring (tn)
23. 3-acetoxyestra-1,3,5(10)-trien-17beta-ol
24. 17beta-hydroxy-3-acetoxyestra-1,3,5(10)-triene
25. Schembl148561
26. Estra-1,3,5(10)-triene-3,17beta-diyl 3-acetate
27. Chembl1200430
28. Dtxsid7045867
29. Estradiol Acetate [vandf]
30. Chebi:135981
31. Estradiol 3-acetate [mi]
32. Estradiol Acetate [mart.]
33. Estradiol Acetate [who-dd]
34. Tox21_111359
35. Tox21_113661
36. Db13952
37. Estradiol Acetate [orange Book]
38. Ncgc00249885-01
39. D04061
40. 3-acetoxy-oestra-1,3,5(10)-trien-17beta-ol
41. 17beta-hydroxyestra-1,3,5(10)-trien-3-yl Acetate
42. 3-(acetyloxy)estra-1,3,5(10)-trien-17.beta.-ol
43. Q27262772
44. 17.beta.-hydroxyestra-1,3,5(10)-trien-3-yl Acetate
45. Estra-1,3,5(10)-triene-3,17-diol, (17beta)-, 3-acetate
46. Estra-1,3,5(10)-triene-3,17-diol, (17 Beta)-, 3-acetate
47. Estra-1,3,5(10)-triene-3,17-diol, (17.beta.)-, 3-acetate
| Molecular Weight | 314.4 g/mol |
|---|---|
| Molecular Formula | C20H26O3 |
| XLogP3 | 2.8 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 3 |
| Rotatable Bond Count | 2 |
| Exact Mass | 314.18819469 g/mol |
| Monoisotopic Mass | 314.18819469 g/mol |
| Topological Polar Surface Area | 46.5 Ų |
| Heavy Atom Count | 23 |
| Formal Charge | 0 |
| Complexity | 476 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 5 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
Femring is indicated for the treatment of vasomotor and urogenital symptoms associated with menopause. Use of Femring (estradiol acetate) has been shown to improve symptoms caused by atrophy of the vagina (such as dryness, burning, pruritus and dyspareunia) and/or the lower urinary tract (urinary urgency and dysuria).
FDA Label
Estrogen mediates its effects across the body through potent agonism of the Estrogen Receptor (ER), which is located in various tissues including in the breasts, uterus, ovaries, skin, prostate, bone, fat, and brain. Estradiol binds to both subtypes of the Estrogen Receptor: Estrogen Receptor Alpha (ER) and Estrogen Receptor Beta (ER). Estradiol also acts as a potent agonist of G Protein-coupled Estrogen Receptor (GPER), which has recently been recognized as a major mediator of estradiol's rapid cellular effects.
Absorption
Drug delivery from Femring is rapid for the first hour and then declines to a relatively constant rate for the remainder of the 3-month dosing interval. Estradiol acetate is rapidly hydrolyzed to estradiol which is absorbed through the vaginal mucosa as evidenced by the mean time to maximum concentration (tmax) for estradiol of about 1 hour (range 0.25 to 1.5 hrs). Following the maximum concentration (Cmax=1129pg/mL), serum estradiol decreases rapidly such that by 24 to 48 hours postdose, serum estradiol concentrations are relatively constant through the end of the 3-month dosing interval.
Route of Elimination
Estradiol, estrone and estriol are excreted in the urine along with glucuronide and sulfate conjugates.
Volume of Distribution
The distribution of exogenous estrogens is similar to that of endogenous estrogens. Estrogens are widely distributed in the body and are generally found in higher concentrations in the sex hormone target organs.
Exogenous estrogens are metabolized using the same mechanism as endogenous estrogens. Estradiol is converted reversibly to estrone, and both can be converted to estriol, which is the major urinary metabolite. Estrogens also undergo enterohepatic recirculation via sulfate and glucuronide conjugation in the liver, biliary secretion of conjugates into the intestine, and hydrolysis in the gut followed by reabsorption. In postmenopausal women, a significant proportion of the circulating estrogens exist as sulfate conjugates, especially estrone sulfate, which serves as a circulating reservoir for the formation of more active estrogens.
Estradiol acetate has known human metabolites that include 6-[(3-acetyloxy-13-methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthren-17-yl)oxy]-3,4,5-trihydroxyoxane-2-carboxylic acid.
S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560
Estradiol enters target cells freely (e.g., female organs, breasts, hypothalamus, pituitary) and interacts with a target cell receptor. When the estrogen receptor has bound its ligand it can enter the nucleus of the target cell, and regulate gene transcription which leads to formation of messenger RNA. The mRNA interacts with ribosomes to produce specific proteins that express the effect of estradiol upon the target cell. Estrogens increase the hepatic synthesis of sex hormone binding globulin (SHBG), thyroid-binding globulin (TBG), and other serum proteins and suppress follicle-stimulating hormone (FSH) from the anterior pituitary. Increases in the down-stream effects of ER binding reverses some of the symptoms of menopause, which are primarily caused by a loss of estrogenic activity.
NDC Package Code : 64918-0105
Start Marketing Date : 2015-10-19
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

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Details:
Estradiol Acetate is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of undefined medical condition.
Lead Product(s): Estradiol Acetate,Inapplicable
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 18, 2010

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Lead Product(s) : Estradiol Acetate,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Estradiol Acetate is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 18, 2010

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Regulatory Info : DISCN
Registration Country : USA
Brand Name : FEMTRACE
Dosage Form : TABLET;ORAL
Dosage Strength : 0.45MG
Packaging :
Approval Date : 2004-08-20
Application Number : 21633
Regulatory Info : DISCN
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Brand Name : FEMTRACE
Dosage Form : TABLET;ORAL
Dosage Strength : 0.9MG
Packaging :
Approval Date : 2004-08-20
Application Number : 21633
Regulatory Info : DISCN
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Brand Name : FEMTRACE
Dosage Form : TABLET;ORAL
Dosage Strength : 1.8MG
Packaging :
Approval Date : 2004-08-20
Application Number : 21633
Regulatory Info : DISCN
Registration Country : USA

Regulatory Info : RX
Registration Country : USA
Brand Name : FEMRING
Dosage Form : INSERT, EXTENDED RELEASE;VAGINAL
Dosage Strength : EQ 0.05MG BASE/24HR
Packaging :
Approval Date : 2003-03-20
Application Number : 21367
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : FEMRING
Dosage Form : INSERT, EXTENDED RELEASE;VAGINAL
Dosage Strength : EQ 0.1MG BASE/24HR
Packaging :
Approval Date : 2003-03-20
Application Number : 21367
Regulatory Info : RX
Registration Country : USA

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Virtual Booth
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RLD : Yes
TE Code :
Brand Name : FEMTRACE
Dosage Form : TABLET;ORAL
Dosage Strength : 0.45MG
Approval Date : 2004-08-20
Application Number : 21633
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
Brand Name : FEMTRACE
Dosage Form : TABLET;ORAL
Dosage Strength : 0.9MG
Approval Date : 2004-08-20
Application Number : 21633
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
Brand Name : FEMTRACE
Dosage Form : TABLET;ORAL
Dosage Strength : 1.8MG
Approval Date : 2004-08-20
Application Number : 21633
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :

Brand Name : FEMRING
Dosage Form : INSERT, EXTENDED RELEASE;VAGINAL
Dosage Strength : EQ 0.05MG BASE/24HR
Approval Date : 2003-03-20
Application Number : 21367
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Brand Name : FEMRING
Dosage Form : INSERT, EXTENDED RELEASE;VAGINAL
Dosage Strength : EQ 0.1MG BASE/24HR
Approval Date : 2003-03-20
Application Number : 21367
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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ANALYTICAL
ABOUT THIS PAGE
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PharmaCompass offers a list of Estradiol Acetate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Estradiol Acetate manufacturer or Estradiol Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Estradiol Acetate manufacturer or Estradiol Acetate supplier.
PharmaCompass also assists you with knowing the Estradiol Acetate API Price utilized in the formulation of products. Estradiol Acetate API Price is not always fixed or binding as the Estradiol Acetate Price is obtained through a variety of data sources. The Estradiol Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Estradiol Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estradiol Acetate, including repackagers and relabelers. The FDA regulates Estradiol Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estradiol Acetate 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 Estradiol Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Estradiol Acetate supplier is an individual or a company that provides Estradiol Acetate active pharmaceutical ingredient (API) or Estradiol Acetate finished formulations upon request. The Estradiol Acetate suppliers may include Estradiol Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Estradiol Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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 Estradiol Acetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Estradiol Acetate API and other APIs are published in this directory by the FDA.
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 Estradiol Acetate 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.
The NDC directory also contains data on finished compounded human drug products that contain Estradiol Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Estradiol Acetate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Estradiol Acetate suppliers with NDC on PharmaCompass.
Estradiol Acetate 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 Estradiol Acetate 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 Estradiol Acetate GMP manufacturer or Estradiol Acetate GMP API supplier for your needs.
A Estradiol Acetate CoA (Certificate of Analysis) is a formal document that attests to Estradiol Acetate's compliance with Estradiol Acetate specifications and serves as a tool for batch-level quality control.
Estradiol Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Estradiol Acetate 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.
Estradiol Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Estradiol Acetate EP), Estradiol Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Estradiol Acetate USP).