Synopsis
Synopsis
0
USDMF
0
KDMF
0
FDA Orange Book
0
Australia
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
FDF
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
0
News #PharmaBuzz
1. Acetate, Buserelin
2. Bigonist
3. Buserelin Acetate
4. Hoe 766
5. Hoe-766
6. Hoe766
7. Profact
8. Receptal
9. Suprecur
10. Suprefact
11. Tiloryth
1. 57982-77-1
2. Pxw8u3yxdv
3. Ici 123215
4. Hoe 766
5. Etilamide
6. (des-gly10,d-ser(tbu)6,pro-nhet9)-lhrh
7. Buserelin (inn)
8. Buserelin [inn]
9. 68630-75-1
10. Buserelina
11. Busereline
12. Buserelinum
13. Luteinizing Hormone-releasing Factor (pig), 6-(o-(1,1-dimethylethyl)-d-serine)-9-(n-ethyl-l-prolinamide)-10-deglycinamide-
14. Buserelin [inn:ban]
15. Unii-pxw8u3yxdv
16. Busereline [inn-french]
17. Buserelinum [inn-latin]
18. Buserelina [inn-spanish]
19. Metrelef
20. Ccris 2657
21. Hoe 766a
22. Tiloryth (tn)
23. Einecs 261-061-9
24. D-ser-(tbu)(sup 6)-lhrh-ethylamide
25. Buserelin [mi]
26. (d-ser(tbu)(sup 6)-ea(sup 10))-lhrh
27. Buserelin [mart.]
28. Buserelin [who-dd]
29. Schembl13354
30. S 746766
31. Gtpl3860
32. Buserelin [ep Monograph]
33. Buserelin For Nmr Identification
34. Chembl2110824
35. D-ser(tbu(sup 6))-lh-rh-(1-9)-nonapeptide Ethylamide
36. Schembl19409318
37. Schembl19459955
38. Buserelin For Peak Identification
39. Chebi:135907
40. Dtxsid301024155
41. (d-ser(bu(sup T)(sup 6)))-lh-rh(1-9)nonapeptide-ethylamide
42. (d-ser(tbu)(sup 6)-ea(sup 10))-luteinizing Hormone-releasing Hormone
43. Akos015994645
44. Akos030213242
45. Luteinizing Hormone-releasing Hormone, (d-ser(tbu)(sup 6)-ea(sup 10))-
46. Hs-2005
47. Ncgc00181295-01
48. D07259
49. 982b771
50. A831694
51. Q414745
52. W-105422
53. (2s)-n-[(2s)-1-[[(2s)-1-[[(2s)-1-[[(2s)-1-[[(2r)-1-[[(2s)-1-[[(2s)-5-(diaminomethylideneamino)-1-[(2s)-2-(ethylcarbamoyl)-1-pyrrolidinyl]-1-oxopentan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-3-[(2-methylpropan-2-yl)oxy]-1-oxopropan-2-yl]amino]-3-(4-hy
54. (2s)-n-[(2s)-1-[[(2s)-1-[[(2s)-1-[[(2s)-1-[[(2r)-1-[[(2s)-1-[[(2s)-5-[bis(azanyl)methylideneamino]-1-[(2s)-2-(ethylcarbamoyl)pyrrolidin-1-yl]-1-oxidanylidene-pentan-2-yl]amino]-4-methyl-1-oxidanylidene-pentan-2-yl]amino]-3-[(2-methylpropan-2-yl)oxy]-1-oxi
55. 5-oxo-l-prolyl-l-histidyl-l-tryptophyl-l-seryl-l-tyrosyl-o-tert-butyl-d-seryl-l-leucyl-l-arginyl-n-ethyl-l-prolinamide
56. Luteinizing Hormone-releasing Hormone (pig), 6-(o-(1,1-dimethylethyl)-d-serine)-9-(n-ethyl-l-prolinamide)-10-deglycinamide-
Molecular Weight | 1239.4 g/mol |
---|---|
Molecular Formula | C60H86N16O13 |
XLogP3 | -0.1 |
Hydrogen Bond Donor Count | 15 |
Hydrogen Bond Acceptor Count | 15 |
Rotatable Bond Count | 33 |
Exact Mass | 1238.65602686 g/mol |
Monoisotopic Mass | 1238.65602686 g/mol |
Topological Polar Surface Area | 441 Ų |
Heavy Atom Count | 89 |
Formal Charge | 0 |
Complexity | 2450 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 9 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Buserelin may be used in the treatment of hormone-responsive cancers such as prostate cancer or breast cancer, estrogen-dependent conditions (such as endometriosis or uterine fibroids), and in assisted reproduction.
The substitution of glycine in position 6 by D-serine, and that of glycinamide in position 10 by ethylamide, leads to a nonapeptide with a greatly enhanced LHRH effect. The effects of buserelin on FSH and LH release are 20 to 170 times greater than those of LHRH. Buserelin also has a longer duration of action than natural LHRH. Investigations in healthy adult males and females have demonstrated that the increase in plasma LH and FSH levels persist for at least 7 hours and that a return to basal values requires about 24 hours. Clinical inhibition of gonadotropin release, and subsequent reduction of serum testosterone or estradiol to castration level, was found when large pharmacologic doses (50-500 mcg SC/day or 300-1200 mcg IN/day) were administered for periods greater than 1 to 3 months. Chronic administration of such doses of buserelin results in sustained inhibition of gonadotropin production, suppression of ovarian and testicular steroidogenesis and, ultimately, reduced circulating levels of gonadotropin and gonadal steroids. These effects form the basis for buserelin use in patients with hormone-dependent metastatic carcinoma of the prostate gland as well as in patients with endometriosis.
Fertility Agents, Female
Compounds which increase the capacity to conceive in females. (See all compounds classified as Fertility Agents, Female.)
L - Antineoplastic and immunomodulating agents
L02 - Endocrine therapy
L02A - Hormones and related agents
L02AE - Gonadotropin releasing hormone analogues
L02AE01 - Buserelin
Absorption
Buserelin is water soluble and readily absorbed after subcutaneous injection (70% bioavailable). However, bioavailability after oral absorption. When administered correctly via the nasal route, it may be absorbed in the nasal mucosa to achieve sufficient plasma levels.
Route of Elimination
Buserelin and its inactive metabolites are excreted via the renal and biliary routes. In man it is excreted in urine at 50% in its intact form.
Volume of Distribution
Buserelin circulates in serum predominantly in intact active form. Preferred accumulation is preferentially in the liver and kidneys as well as in the anterior pituitary lobe, the biological target organ.
It is metabolized and subsequently inactivated by peptidase (pyroglutamyl peptidase and chymotrypsin-like endopeptidase) in the liver and kidneys as well as in the gastrointestinal tract. In the pituitary gland, it is inactivated by membrane-located enzymes.
The elimination half-life is approximately 50 to 80 minutes following intravenous administration, 80 minutes after subcutaneous administration and approximately 1 to 2 hours after intranasal administration.
Buserelin stimulates the pituitary gland's gonadotrophin-releasing hormone receptor (GnRHR). Buserelin desensitizes the GnRH receptor, reducing the amount of gonadotropin. In males, this results in a reduction in the synthesis and release of testosterone. In females, estrogen secretion is inhibited. While initially, there is a rise in FSH and LH levels, chronic administration of Buserelin results in a sustained suppression of these hormones.
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
---|
Upgrade, download data, analyse, strategize, subscribe with us
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
91
PharmaCompass offers a list of Buserelin 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 Buserelin Acetate manufacturer or Buserelin Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Buserelin Acetate manufacturer or Buserelin Acetate supplier.
PharmaCompass also assists you with knowing the Buserelin Acetate API Price utilized in the formulation of products. Buserelin Acetate API Price is not always fixed or binding as the Buserelin Acetate Price is obtained through a variety of data sources. The Buserelin Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone, including repackagers and relabelers. The FDA regulates (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone 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 (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone supplier is an individual or a company that provides (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone active pharmaceutical ingredient (API) or (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone finished formulations upon request. The (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone suppliers may include (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone API manufacturers, exporters, distributors and traders.
click here to find a list of (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone Drug Master File in Japan ((D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone JDMF) empowers (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone 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 (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone JDMF during the approval evaluation for pharmaceutical products. At the time of (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone 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 (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone suppliers with JDMF on PharmaCompass.
A (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone CEP of the European Pharmacopoeia monograph is often referred to as a (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone Certificate of Suitability (COS). The purpose of a (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone to their clients by showing that a (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone CEP has been issued for it. The manufacturer submits a (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone CEP (COS) as part of the market authorization procedure, and it takes on the role of a (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone CEP holder for the record. Additionally, the data presented in the (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone DMF.
A (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone 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 (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone suppliers with CEP (COS) on PharmaCompass.
A (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone written confirmation ((D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone WC) is an official document issued by a regulatory agency to a (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone manufacturer, verifying that the manufacturing facility of a (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone APIs or (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone finished pharmaceutical products to another nation, regulatory agencies frequently require a (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone WC (written confirmation) as part of the regulatory process.
click here to find a list of (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone suppliers with Written Confirmation (WC) 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 (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone 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 (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone 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 (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone suppliers with NDC on PharmaCompass.
(D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone 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 (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone 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 (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone GMP manufacturer or (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone GMP API supplier for your needs.
A (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone CoA (Certificate of Analysis) is a formal document that attests to (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone's compliance with (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone specifications and serves as a tool for batch-level quality control.
(D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone CoA mostly includes findings from lab analyses of a specific batch. For each (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone 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.
(D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone may be tested according to a variety of international standards, such as European Pharmacopoeia ((D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone EP), (D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone JP (Japanese Pharmacopeia) and the US Pharmacopoeia ((D-Ser(tbu)(sup 6)-EA(sup 10))-luteinizing hormone-releasing hormone USP).