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Chemistry

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Also known as: 15183-37-6, Estetrol anhydrous, 15.alpha.-hydroxyestriol, Enb39r14vf, (8r,9s,13s,14s,15r,16r,17r)-13-methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthrene-3,15,16,17-tetrol, Estetrol (usan)
Molecular Formula
C18H24O4
Molecular Weight
304.4  g/mol
InChI Key
AJIPIJNNOJSSQC-NYLIRDPKSA-N
FDA UNII
ENB39R14VF

Estetrol
A metabolite of ESTRIOL with a 15-alpha-hydroxyl group. Estetrol can be converted from estriol sulfate or DEHYDROEPIANDROSTERONE SULFATE by the fetal-placental unit.
Estetrol anhydrous is an Estrogen. The mechanism of action of estetrol anhydrous is as an Estrogen Receptor Agonist.
1 2D Structure

Estetrol

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(8R,9S,13S,14S,15R,16R,17R)-13-methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthrene-3,15,16,17-tetrol
2.1.2 InChI
InChI=1S/C18H24O4/c1-18-7-6-12-11-5-3-10(19)8-9(11)2-4-13(12)14(18)15(20)16(21)17(18)22/h3,5,8,12-17,19-22H,2,4,6-7H2,1H3/t12-,13-,14-,15-,16-,17+,18+/m1/s1
2.1.3 InChI Key
AJIPIJNNOJSSQC-NYLIRDPKSA-N
2.1.4 Canonical SMILES
CC12CCC3C(C1C(C(C2O)O)O)CCC4=C3C=CC(=C4)O
2.1.5 Isomeric SMILES
C[C@]12CC[C@H]3[C@H]([C@@H]1[C@H]([C@H]([C@@H]2O)O)O)CCC4=C3C=CC(=C4)O
2.2 Other Identifiers
2.2.1 UNII
ENB39R14VF
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 15 Alpha Hydroxy Estriol

2. 15 Alpha Hydroxyestriol

3. 15 Alpha-hydroxyestriol

4. 15-alpha-hydroxy-estriol

2.3.2 Depositor-Supplied Synonyms

1. 15183-37-6

2. Estetrol Anhydrous

3. 15.alpha.-hydroxyestriol

4. Enb39r14vf

5. (8r,9s,13s,14s,15r,16r,17r)-13-methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthrene-3,15,16,17-tetrol

6. Estetrol (usan)

7. Estetrol [usan]

8. (8r,9s,13s,14s,15r,16r,17r)-13-methyl-7,8,9,11,12,13,14,15,16,17-decahydro-6h-cyclopenta[a]phenanthrene-3,15,16,17-tetraol

9. E4

10. (14beta,15alpha,16alpha,17alpha)-estra-1,3,5(10)-triene-3,15,16,17-tetrol

11. E-4

12. Unii-enb39r14vf

13. Estell

14. Estetrolum

15. Oestetrol

16. Donesta

17. Estetrol (anhydrous)

18. 15alpha-hydroxyestriol

19. 15 Alpha-hydroxyestriol

20. Estetrol [inn]

21. Estetrol [who-dd]

22. Mls006010253

23. Schembl145580

24. Estetrol, >=98% (hplc)

25. Chembl1230314

26. Gtpl11591

27. Dtxsid50164888

28. Chebi:142773

29. Bdbm158505

30. Zinc5764481

31. Estetrol (anhydrous) [usan]

32. Who 10439

33. Akos030254521

34. At27982

35. Db12235

36. Ncgc00345819-03

37. Hy-15731

38. Smr004701329

39. Us9034854, E4

40. Cs-0008552

41. D11513

42. J-008852

43. Q5401078

44. Drovelis (ema); ; Estetrol Monohydrate + Drospirenone

45. Lydisilka (ema); ; Estetrol Monohydrate + Drospirenone

46. Nextstellis (us); Estetrol Monohydrate + Drospirenone

47. 1,3,5(10)-estratrien-3,15alpha,16alpha,17beta-tetrol

48. Estra-1(10),2,4-triene-3,15alpha,16alpha,17beta-tetrol

49. Estra-1,3,5(10)-triene-3,15alpha,16alpha,17beta-tetrol

50. 3,15alpha,16alpha,17beta-tetrahydroxyestra-1,3,5(10)-triene

51. Estra-1,3,5(10)-triene-3,15 Alpha,16alpha,17beta-tetrol

52. (15alpha,16alpha,17beta)-estra-1(10),2,4-triene-3,15,16,17-tetrol

53. Estra-1,3,5(10)-triene-3,15,16,17-tetrol, (15alpha,16alpha,17beta)-

54. Estra-1,3,5(10)-triene-3,15.alpha.,16.alpha.,17.beta.-tetrol

55. Estra-1,3,5(10)-triene-3,15,16,17-tetrol, (15.alpha.,16.alpha.,17.beta.)-

56. 4oh

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 304.4 g/mol
Molecular Formula C18H24O4
XLogP31.5
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count4
Rotatable Bond Count0
Exact Mass304.16745924 g/mol
Monoisotopic Mass304.16745924 g/mol
Topological Polar Surface Area80.9 Ų
Heavy Atom Count22
Formal Charge0
Complexity441
Isotope Atom Count0
Defined Atom Stereocenter Count7
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Estetrol is indicated in combination with drospirenone for the prevention of pregnancy.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Estetrol prevents pregnancy by suppressing ovulation.


5.2 FDA Pharmacological Classification
5.2.1 Active Moiety
ESTETROL ANHYDROUS
5.2.2 FDA UNII
ENB39R14VF
5.2.3 Pharmacological Classes
Mechanisms of Action [MoA] - Estrogen Receptor Agonists
5.3 Absorption, Distribution and Excretion

Absorption

Estetrol is rapidly absorbed from the gastrointestinal tract. The Cmax of estetrol is 18 ng/mL according to the results of a pharmacokinetic study, with an AUC of 36.4 ngh/mL. When estetrol and drospirenone are taken in a single product, maximum serum concentrations of approximately 48.7 ng/mL are achieved within 1-3 h. Bioavailability of the combination ranges between 76 and 85%. The Tmax can range from 0.5 to 2 hours and time to steady state is approximately 4 days, according to the results of one clinical study.


Route of Elimination

Estrogens are generally excreted as sulfated and glucuronidated derivatives. Approximately 69% of a dose of estetrol is excreted in the urine, and about 22% is excreted in the feces as unchanged drug.


Volume of Distribution

Limited distribution of estetrol into red blood cells has been demonstrated.


5.4 Metabolism/Metabolites

Estretol is heavily metabolized after oral administration. Phase 2 metabolism of estrogen forms glucuronide and sulfate conjugates with negligible in-vitro estrogenic activity. In vitro metabolism studies demonstrate that UGT2B7 catalyzes the formation of E4-16-glucuronide. Estetrol is combined with [drospirenone] in a product. The hepatic cytochrome enzyme CYP3A4 metabolizes drospirenone to two primary metabolites: the acid form of drospirenone through the opening of the lactone ring and the 4,5 dihydrodrospirenone formed by reduction, followed by sulfation. Both metabolites are pharmacologically inactive.


5.5 Biological Half-Life

The elimination half-life of estetrol is approximately 27 hours. Half-life may range between 19-40 hours.


5.6 Mechanism of Action

Estetrol is a synthetic analogue of a naturally occurring estrogen present during pregnancy, demonstrating selectivity for both estrogen receptor- (ER-) and ER- and suppressing ovulation. Estetrol binds with a low to moderate affinity human estrogen receptor alpha (ER alpha) and ER beta with a preference for ER alpha. Estetrol demonstrates a unique mechanism of action via tissue selective activity, showing estrogen receptor agonist activity on the vagina, the uterus and the endometrium, and negative estrogenic activity on breast tissue.


API SUPPLIERS

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Transo-Pharm Handels GmbH

Germany

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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PCAS

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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Seqens

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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  • WHO-GMP

Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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Gedeon Richter

Hungary

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

EPS
Not Confirmed
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Gedeon Richter

Hungary

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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EPS
Not Confirmed
USDMF arrow-down CEP/COS JDMF arrow-down EU-WC NDC KDMF VMF Others AUDIT
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Key Organics

United Kingdom

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

EPS
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Key Organics

United Kingdom

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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JDMF

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CRS
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Estetrol Hydrate

Registration Number : 305MF10111

Registrant's Address : BUDAPEST, GYOMROI UT 19-21, HUNGARY

Initial Date of Registration : 2023-09-26

Latest Date of Registration : 2023-09-26

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NDC API

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PCAS

France
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  • EDQM
  • WHO-GMP

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ESTETROL

NDC Package Code : 10577-918

Start Marketing Date : 2019-11-15

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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Virtual BoothTranso-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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Estetrol

About the Company : Founded in 1987, Transo-Pharm is a fully licensed and certified global distributor of pharmaceutical components for the health and veterinary industries. The company supports its c...

Founded in 1987, Transo-Pharm is a fully licensed and certified global distributor of pharmaceutical components for the health and veterinary industries. The company supports its customers throughout the complete lifecycle of APIs, from product development to market research, sourcing, import-export and sales. Transo-Pharm offers a diverse range of products. It qualifies manufacturers for full compliance and serves both as a valuable sourcing agent for its clients and a regulatory marketing agent for API manufacturers. It has offices in Shanghai, Hong Kong, Singapore, the United States, and an affiliated office in Mumbai.
Transo Pharm Handels GmbH

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Key Organics

United Kingdom
EPS
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Key Organics

United Kingdom
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Estetrol

About the Company : A UK-based international Contract Research Organization (CRO) with more than 32 years of specialized knowledge in synthetic organic chemistry. Our clientele spans across large phar...

A UK-based international Contract Research Organization (CRO) with more than 32 years of specialized knowledge in synthetic organic chemistry. Our clientele spans across large pharmaceutical and agrochemical companies, medium-sized biotech firms, academic groups, virtual organizations, and startups. We provide a diverse array of tailored chemistry solutions, ranging from the custom synthesis of individual compounds to extensive, ongoing Full-Time Equivalent (FTE) projects.
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Drugs in Development

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Details:

Nextstellis is a novel combination medication comprising of drospirenone (DRSP) and estetrol (E4), indicated for use by women of reproductive age to prevent pregnancy.


Lead Product(s): Drospirenone,Estetrol

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Nextstellis

Study Phase: Approved FDFProduct Type: Hormone

Sponsor: OLIC

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement December 06, 2024

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Lupin Ltd

India
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Lupin Ltd

India
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Details : Nextstellis is a novel combination medication comprising of drospirenone (DRSP) and estetrol (E4), indicated for use by women of reproductive age to prevent pregnancy.

Product Name : Nextstellis

Product Type : Hormone

Upfront Cash : Undisclosed

December 06, 2024

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Details:

Donesta (estetrol) is a next generation orally administered Estetrol (E4)-based hormone therapy product, which is under phase 3 clinical development for the treatment of the symptoms of menopause.


Lead Product(s): Estetrol

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Donesta

Study Phase: Phase IIIProduct Type: Hormone

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 29, 2024

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02

CRS
Not Confirmed
CRS
Not Confirmed

Details : Donesta (estetrol) is a next generation orally administered Estetrol (E4)-based hormone therapy product, which is under phase 3 clinical development for the treatment of the symptoms of menopause.

Product Name : Donesta

Product Type : Hormone

Upfront Cash : Inapplicable

February 29, 2024

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Details:

Estelle (estetrol monohydrate) is an estrogen receptor agonist small molecule drug candidate, which is currently being evaluated in combination with drospirenone for contraception for 12 to 17 years aged females.


Lead Product(s): Estetrol,Drospirenone

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Estelle

Study Phase: Phase IIIProduct Type: Hormone

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 20, 2023

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03

CRS
Not Confirmed
CRS
Not Confirmed

Details : Estelle (estetrol monohydrate) is an estrogen receptor agonist small molecule drug candidate, which is currently being evaluated in combination with drospirenone for contraception for 12 to 17 years aged females.

Product Name : Estelle

Product Type : Hormone

Upfront Cash : Inapplicable

December 20, 2023

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Details:

Donesta (estetrol) is a next generation orally administered Estetrol (E4)-based hormone therapy product, which is under phase 3 clinical development for the treatment of the symptoms of menopause.


Lead Product(s): Estetrol

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Donesta

Study Phase: Phase IIIProduct Type: Hormone

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 18, 2023

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04

CRS
Not Confirmed
CRS
Not Confirmed

Details : Donesta (estetrol) is a next generation orally administered Estetrol (E4)-based hormone therapy product, which is under phase 3 clinical development for the treatment of the symptoms of menopause.

Product Name : Donesta

Product Type : Hormone

Upfront Cash : Inapplicable

December 18, 2023

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Details:

Donesta (estetrol) is a hormone capsule formulation acting as an Estrogen receptor agonist, approved for the treatment of alleviating symptoms of menopause.


Lead Product(s): Estetrol

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Donesta

Study Phase: Phase IIIProduct Type: Hormone

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 30, 2023

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05

CRS
Not Confirmed
CRS
Not Confirmed

Details : Donesta (estetrol) is a hormone capsule formulation acting as an Estrogen receptor agonist, approved for the treatment of alleviating symptoms of menopause.

Product Name : Donesta

Product Type : Hormone

Upfront Cash : Inapplicable

November 30, 2023

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Details:

Under the terms of the agreement, Searchlight will have sales and marketing rights for DONESTA® in Canada. DONESTA (estetrol) phase 3 clinical program, which demonstrated a meaningful reduction in the frequency and severity of vasomotor symptoms compared to placebo.


Lead Product(s): Estetrol

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Donesta

Study Phase: Phase IIIProduct Type: Hormone

Sponsor: SEARCHLIGHT PHARMA

Deal Size: $17.9 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement October 26, 2023

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06

CRS
Not Confirmed
CRS
Not Confirmed

Details : Under the terms of the agreement, Searchlight will have sales and marketing rights for DONESTA® in Canada. DONESTA (estetrol) phase 3 clinical program, which demonstrated a meaningful reduction in the frequency and severity of vasomotor symptoms compare...

Product Name : Donesta

Product Type : Hormone

Upfront Cash : Undisclosed

October 26, 2023

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Details:

Under the agreements, Fuji Pharma obtains the rights to commercialize and advance the develoopment of Estelle, Mithra’s oral contraceptive product candidate based on Estetrol, for the treatment of Japanese patients with dysmenorrhea or endometriosis, in Japan and ASEAN.


Lead Product(s): Estetrol,Drospirenone

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Estelle

Study Phase: Approved FDFProduct Type: Hormone

Sponsor: Fuji Pharma

Deal Size: $45.4 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement October 23, 2023

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07

CRS
Not Confirmed
CRS
Not Confirmed

Details : Under the agreements, Fuji Pharma obtains the rights to commercialize and advance the develoopment of Estelle, Mithra’s oral contraceptive product candidate based on Estetrol, for the treatment of Japanese patients with dysmenorrhea or endometriosis, i...

Product Name : Estelle

Product Type : Hormone

Upfront Cash : Undisclosed

October 23, 2023

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Details:

Estelle® is a novel patent protected combined oral contraceptive pill containing 3 mg drospirenone (DRSP) and 15 mg estetrol (E4). E4 is a naturally produced estrogen during pregnancy, which can now be made from a plant source.


Lead Product(s): Estetrol,Drospirenone

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Estelle

Study Phase: Phase IIIProduct Type: Hormone

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 05, 2023

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08

CRS
Not Confirmed
CRS
Not Confirmed

Details : Estelle® is a novel patent protected combined oral contraceptive pill containing 3 mg drospirenone (DRSP) and 15 mg estetrol (E4). E4 is a naturally produced estrogen during pregnancy, which can now be made from a plant source.

Product Name : Estelle

Product Type : Hormone

Upfront Cash : Inapplicable

October 05, 2023

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Details:

The proceeds will support the NDA filing of Donesta, a next generation Estetrol-based hormone therapy, and to support differentiation for treatment of menopause symptoms related to hair, skin and sexual desire, and for the development of Estetrol and Zoreline.


Lead Product(s): Estetrol

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Donesta

Study Phase: Phase IIProduct Type: Hormone

Sponsor: H.C. Wainwright & Co

Deal Size: $70.1 million Upfront Cash: Undisclosed

Deal Type: Private Placement August 24, 2023

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09

CRS
Not Confirmed
CRS
Not Confirmed

Details : The proceeds will support the NDA filing of Donesta, a next generation Estetrol-based hormone therapy, and to support differentiation for treatment of menopause symptoms related to hair, skin and sexual desire, and for the development of Estetrol and Zor...

Product Name : Donesta

Product Type : Hormone

Upfront Cash : Undisclosed

August 24, 2023

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Details:

Under the agreement, Searchlight will have the Canadian rights to Donesta, a next generation orally administered Estetrol (E4)-based hormone therapy product, for the treatment of the symptoms of menopause.


Lead Product(s): Estetrol

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Donesta

Study Phase: Phase IIIProduct Type: Hormone

Sponsor: SEARCHLIGHT PHARMA

Deal Size: $18.7 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement July 31, 2023

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10

CRS
Not Confirmed
CRS
Not Confirmed

Details : Under the agreement, Searchlight will have the Canadian rights to Donesta, a next generation orally administered Estetrol (E4)-based hormone therapy product, for the treatment of the symptoms of menopause.

Product Name : Donesta

Product Type : Hormone

Upfront Cash : Undisclosed

July 31, 2023

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ABOUT THIS PAGE

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API | Excipient name

Estetrol

Synonyms

15183-37-6, Estetrol anhydrous, 15.alpha.-hydroxyestriol, Enb39r14vf, (8r,9s,13s,14s,15r,16r,17r)-13-methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthrene-3,15,16,17-tetrol, Estetrol (usan)

Cas Number

15183-37-6

Unique Ingredient Identifier (UNII)

ENB39R14VF

About Estetrol

A metabolite of ESTRIOL with a 15-alpha-hydroxyl group. Estetrol can be converted from estriol sulfate or DEHYDROEPIANDROSTERONE SULFATE by the fetal-placental unit.

Estetrol Manufacturers

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

Estetrol Suppliers

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

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

Estetrol USDMF

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

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

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

Estetrol 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 Estetrol as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Estetrol GMP

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

Estetrol CoA

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

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

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