Synopsis
Synopsis
0
CEP/COS
0
JDMF
0
EU WC
0
VMF
DRUG PRODUCT COMPOSITIONS
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
1. Ac-2nal-4cpa-3pal-ser-4aph(hydroorotyl)-4aph(carbamoyl)-leu-ilys-pro-ala-nh2
2. Acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ilys-prolyl-alaninamide
3. Degarelix
4. Fe 200486
5. Fe-200486
6. Fe200486
7. Firmagon
8. Gonax
9. Uglypeptide1
1. 934016-19-0
2. Gonax
3. Firmagon
4. Ext215f4zu
5. Degarelix (as Acetate)
6. Degarelix Acetate Hydrate
7. Fe-200486
8. Degarelix Acetate (jan)
9. N-acetyl-3-(2-naphthalenyl)-d-alanyl-4-chloro-d-phenylalanyl-3-(3-pyridinyl)-d-alanyl-l-seryl-4-[[[(4s)-hexahydro-2,6-dioxo-4-pyrimidinyl]carbonyl]amino]-l-phenylalanyl-4-[(aminocarbonyl)amino]-d-phenylalanyl-l-leucyl-n6-(1-methylethyl)-l-lysyl-l-prolyl-d-alaninamide,monoacetate
10. Asp3550
11. Fe200486
12. Unii-ext215f4zu
13. Fe200486 (free Base)
14. Firmagon (tn)
15. Degarelix Monoacetate
16. Chembl2028987
17. Degarelix Acetate Anhydrous
18. Dtxsid201027699
19. Asp-3550
20. Mfcd16879085
21. Degarelix Monoacetate Anhydrous
22. Degarelix (acetate) Pound>>fe 200486
23. Degarelix Acetate(214766-78-6 Free Base)
24. D09400
25. Q27277419
26. D-alaninamide, N-acetyl-3-(naphtalen-2-yl)-d-alanyl-4-chloro-d-phenylalanyl-3-(pyridin-3-yl)-d-alanyl-l-seryl-4-((((4s)-2,6-dioxohexahydropyrimidin-4-yl)carbonyl)amino)-l-phenylalanyl-4-(carbamoylamino)-d-phenylalanyl-l-leucyl-n6-(1-methylethyl)-l-lysyl-l-prolyl-, Acetate (1:1)
Molecular Weight | 1692.3 g/mol |
---|---|
Molecular Formula | C84H107ClN18O18 |
Hydrogen Bond Donor Count | 18 |
Hydrogen Bond Acceptor Count | 20 |
Rotatable Bond Count | 41 |
Exact Mass | 1690.7699263 g/mol |
Monoisotopic Mass | 1690.7699263 g/mol |
Topological Polar Surface Area | 550 Ų |
Heavy Atom Count | 121 |
Formal Charge | 0 |
Complexity | 3420 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 11 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist indicated:
- for treatment of adult male patients with advanced hormone-dependent prostate cancer .
- for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.
- as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer .
L02BX02
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
---|
Upgrade, download data, analyse, strategize, subscribe with us
RLD : Yes
TE Code :
Brand Name : FIRMAGON
Dosage Form : POWDER;SUBCUTANEOUS
Dosage Strength : EQ 80MG BASE/VIAL
Approval Date : 2008-12-24
Application Number : 22201
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : FIRMAGON
Dosage Form : POWDER;SUBCUTANEOUS
Dosage Strength : EQ 120MG BASE/VIAL
Approval Date : 2008-12-24
Application Number : 22201
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Regulatory Info :
Registration Country : Sweden
Brand Name : FIRMAGON
Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Dosage Strength : 80 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : FIRMAGON
Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Dosage Strength : 120 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : Firmagon
Dosage Form : Degarelix 120Mg 2 Units Parenteral Use
Dosage Strength : 2 vials groun 120 mg + 2 Syringes solv 3 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Firmagon
Dosage Form : Degarelix 80Mg 1 Unit Parenteral Use
Dosage Strength : 1 vial 80 mg groun + 1 syringe solv 4,2 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Firm Agon
Dosage Form : Powder and liquid to the injection fluid, resolution
Dosage Strength : 120 mg
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Firm Agon
Dosage Form : Powder and liquid to the injection fluid, resolution
Dosage Strength : 80 mg
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Firmagon
Dosage Form : Trockensub
Dosage Strength : 120mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Firmagon
Dosage Form : Trockensub
Dosage Strength : 80mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Global Sales Information
Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Degarelix Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Degarelix Acetate, including repackagers and relabelers. The FDA regulates Degarelix Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Degarelix 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 Degarelix Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Degarelix Acetate supplier is an individual or a company that provides Degarelix Acetate active pharmaceutical ingredient (API) or Degarelix Acetate finished formulations upon request. The Degarelix Acetate suppliers may include Degarelix Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Degarelix Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Degarelix Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Degarelix Acetate active pharmaceutical ingredient (API) in detail. Different forms of Degarelix Acetate DMFs exist exist since differing nations have different regulations, such as Degarelix Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Degarelix Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Degarelix Acetate USDMF includes data on Degarelix Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Degarelix Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Degarelix Acetate suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Degarelix Acetate Drug Master File in Korea (Degarelix Acetate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Degarelix Acetate. The MFDS reviews the Degarelix Acetate KDMF as part of the drug registration process and uses the information provided in the Degarelix Acetate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Degarelix Acetate 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 Degarelix Acetate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Degarelix Acetate suppliers with KDMF 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 Degarelix Acetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Degarelix 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 Degarelix 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 Degarelix Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Degarelix Acetate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Degarelix Acetate suppliers with NDC on PharmaCompass.
Degarelix 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 Degarelix 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 Degarelix Acetate GMP manufacturer or Degarelix Acetate GMP API supplier for your needs.
A Degarelix Acetate CoA (Certificate of Analysis) is a formal document that attests to Degarelix Acetate's compliance with Degarelix Acetate specifications and serves as a tool for batch-level quality control.
Degarelix Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Degarelix 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.
Degarelix Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Degarelix Acetate EP), Degarelix Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Degarelix Acetate USP).
LOOKING FOR A SUPPLIER?