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1. 15 Alpha Hydroxy Estriol
2. 15 Alpha Hydroxyestriol
3. 15 Alpha-hydroxyestriol
4. 15-alpha-hydroxy-estriol
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
Molecular Weight | 304.4 g/mol |
---|---|
Molecular Formula | C18H24O4 |
XLogP3 | 1.5 |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 4 |
Rotatable Bond Count | 0 |
Exact Mass | 304.16745924 g/mol |
Monoisotopic Mass | 304.16745924 g/mol |
Topological Polar Surface Area | 80.9 Ų |
Heavy Atom Count | 22 |
Formal Charge | 0 |
Complexity | 441 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 7 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Estetrol is indicated in combination with drospirenone for the prevention of pregnancy.
Estetrol prevents pregnancy by suppressing ovulation.
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.
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.
The elimination half-life of estetrol is approximately 27 hours. Half-life may range between 19-40 hours.
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.
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34214
Submission : 2019-11-27
Status : Active
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37136
Submission : 2022-06-10
Status : Active
Type : II
Registration Number : 305MF10111
Registrant's Address : BUDAPEST, GYOMROI UT 19-21, HUNGARY
Initial Date of Registration : 2023-09-26
Latest Date of Registration :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34214
Submission : 2019-11-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37136
Submission : 2022-06-10
Status : Active
Type : II
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
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
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
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
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...
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...
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
Lead Product(s) : Drospirenone,Estetrol
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : OLIC
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Lupin partners with Fuji to strengthen women's health portfolio in Vietnam and Philippines
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
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
Lead Product(s) : Estetrol
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Caring Cross and ImmunoACT Ink Agreement to Commercialize TriCAR-T Immunotherapy
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
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
Lead Product(s) : Estetrol,Drospirenone
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Mithra Completes Pediatric Study of ESTELLE® in Adolescent Patients
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
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
Lead Product(s) : Estetrol
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Mithra Receives Positive DSMB Opinion on DONESTA® European Phase 3 Trial
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
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
Lead Product(s) : Estetrol
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Mithra Receives Guidance From the FDA for the DONESTA® NDA Marketing Authorization Filing in The ...
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
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
Lead Product(s) : Estetrol
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : SEARCHLIGHT PHARMA
Deal Size : $17.9 million
Deal Type : Licensing Agreement
Mithra and Searchlight Pharma Sign DONESTA® Licensing Agreement for Canada
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
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
Lead Product(s) : Estetrol,Drospirenone
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Fuji Pharma
Deal Size : $45.4 million
Deal Type : Licensing Agreement
Mithra to Receive EUR 2.5 Million Milestone Payment from Fuji Pharma under ESTELLE® Licensing Agr...
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
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
Lead Product(s) : Estetrol,Drospirenone
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Mithra Announces Completion of Recruitment in Pediatric Study of Estelle in Adolescent Patients
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
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
Lead Product(s) : Estetrol
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : H.C. Wainwright & Co
Deal Size : $70.1 million
Deal Type : Private Placement
Mithra Prices Private Placement to Raise EUR 20 Million in Equity
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
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
Lead Product(s) : Estetrol
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : SEARCHLIGHT PHARMA
Deal Size : $18.7 million
Deal Type : Licensing Agreement
Mithra and Searchlight Pharma Announce Donesta® Licensing Agreement for Canada
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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PharmaCompass offers a list of Estetrol 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 Estetrol manufacturer or Estetrol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Estetrol manufacturer or Estetrol supplier.
PharmaCompass also assists you with knowing the Estetrol API Price utilized in the formulation of products. Estetrol API Price is not always fixed or binding as the Estetrol Price is obtained through a variety of data sources. The Estetrol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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.
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.
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.
click here to find a list of Estetrol suppliers with USDMF on PharmaCompass.
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.
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).
The FDA updates the NDC directory daily. The NDC numbers for Estetrol 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 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.
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 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.
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).