Synopsis
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EU WC
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KDMF
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Europe
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Australia
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1. Cystorelin
2. Dirigestran
3. Factrel
4. Fsh Releasing Hormone
5. Fsh-releasing Hormone
6. Gn-rh
7. Gnrh
8. Gonadoliberin
9. Gonadorelin
10. Gonadorelin Acetate
11. Gonadorelin Hydrochloride
12. Gonadotropin Releasing Hormone
13. Gonadotropin-releasing Hormone
14. Kryptocur
15. Lfrh
16. Lh Fsh Releasing Hormone
17. Lh Releasing Hormone
18. Lh-fsh Releasing Hormone
19. Lh-releasing Hormone
20. Lh-rh
21. Lhfsh Releasing Hormone
22. Lhfshrh
23. Lhrh
24. Luliberin
25. Luteinizing Hormone Releasing Hormone
26. Luteinizing Hormone-releasing Hormone
27. Releasing Hormone, Lhfsh
1. Gonadorelin Hydrochloride
Molecular Weight | 1218.7 g/mol |
---|---|
Molecular Formula | C55H76ClN17O13 |
Hydrogen Bond Donor Count | 17 |
Hydrogen Bond Acceptor Count | 15 |
Rotatable Bond Count | 31 |
Exact Mass | 1217.5497032 g/mol |
Monoisotopic Mass | 1217.5497032 g/mol |
Topological Polar Surface Area | 475 Ų |
Heavy Atom Count | 86 |
Formal Charge | 0 |
Complexity | 2390 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 8 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5067
Submission : 1983-08-31
Status : Inactive
Type : II
NDC Package Code : 73212-051
Start Marketing Date : 2022-01-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 71052-909
Start Marketing Date : 2020-05-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Related Excipient Companies
Excipients by Applications
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Tablet
Grade : Parenteral, Oral, Topical
Category : Parenteral, Solubilizers, Topical
Dosage Form : Cream / Lotion / Ointment, Injectable / Parenteral
Grade : Parenteral and Topical
Category : Parenteral, Topical
Application : Parenteral, Topical
Brand Name : Sodium Chloride USP
Application : Parenteral
Excipient Details : A & C's Sodium Chloride is an excipient meeting the USP monograph.
Brand Name : NaCl Multi-compendial Low Endotoxin
Application : Parenteral
Excipient Details : A & C's Sodium Chloride multi-compendial low endotoxin is an excipient meeting USP-NF, EP, BP and JP monographs.
Pharmacopoeia Ref : Multi-compendial
Technical Specs : Low Endotoxin
Ingredient(s) : Sodium Chloride Excipient
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Gonadorelin Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gonadorelin Hydrochloride, including repackagers and relabelers. The FDA regulates Gonadorelin Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gonadorelin Hydrochloride 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 Gonadorelin Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gonadorelin Hydrochloride supplier is an individual or a company that provides Gonadorelin Hydrochloride active pharmaceutical ingredient (API) or Gonadorelin Hydrochloride finished formulations upon request. The Gonadorelin Hydrochloride suppliers may include Gonadorelin Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Gonadorelin Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gonadorelin Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Gonadorelin Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Gonadorelin Hydrochloride DMFs exist exist since differing nations have different regulations, such as Gonadorelin Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gonadorelin Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Gonadorelin Hydrochloride USDMF includes data on Gonadorelin Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gonadorelin Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gonadorelin Hydrochloride suppliers with USDMF 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 Gonadorelin Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Gonadorelin Hydrochloride 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 Gonadorelin Hydrochloride 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 Gonadorelin Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gonadorelin Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Gonadorelin Hydrochloride suppliers with NDC on PharmaCompass.
Gonadorelin Hydrochloride 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 Gonadorelin Hydrochloride 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 Gonadorelin Hydrochloride GMP manufacturer or Gonadorelin Hydrochloride GMP API supplier for your needs.
A Gonadorelin Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Gonadorelin Hydrochloride's compliance with Gonadorelin Hydrochloride specifications and serves as a tool for batch-level quality control.
Gonadorelin Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Gonadorelin Hydrochloride 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.
Gonadorelin Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Gonadorelin Hydrochloride EP), Gonadorelin Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gonadorelin Hydrochloride USP).
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