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Synopsis

Synopsis

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NDC API

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5 RELATED EXCIPIENT COMPANIES

6EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Gonadorelin hydrochloride
Molecular Formula
C55H76ClN17O13
Molecular Weight
1218.7  g/mol
InChI Key
UPRWQSQENCASAD-UHFFFAOYSA-N

Gonadorelin Hydrochloride
A decapeptide that stimulates the synthesis and secretion of both pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE. GnRH is produced by neurons in the septum PREOPTIC AREA of the HYPOTHALAMUS and released into the pituitary portal blood, leading to stimulation of GONADOTROPHS in the ANTERIOR PITUITARY GLAND.
1 2D Structure

Gonadorelin Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
N-[1-[[1-[[1-[[1-[[2-[[1-[[1-[2-[(2-amino-2-oxoethyl)carbamoyl]pyrrolidin-1-yl]-5-(diaminomethylideneamino)-1-oxopentan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-2-oxoethyl]amino]-3-(4-hydroxyphenyl)-1-oxopropan-2-yl]amino]-3-hydroxy-1-oxopropan-2-yl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]amino]-3-(1H-imidazol-5-yl)-1-oxopropan-2-yl]-5-oxopyrrolidine-2-carboxamide;hydrochloride
2.1.2 InChI
InChI=1S/C55H75N17O13.ClH/c1-29(2)19-38(49(80)67-37(9-5-17-60-55(57)58)54(85)72-18-6-10-43(72)53(84)62-25-44(56)75)66-46(77)26-63-47(78)39(20-30-11-13-33(74)14-12-30)68-52(83)42(27-73)71-50(81)40(21-31-23-61-35-8-4-3-7-34(31)35)69-51(82)41(22-32-24-59-28-64-32)70-48(79)36-15-16-45(76)65-36;/h3-4,7-8,11-14,23-24,28-29,36-43,61,73-74H,5-6,9-10,15-22,25-27H2,1-2H3,(H2,56,75)(H,59,64)(H,62,84)(H,63,78)(H,65,76)(H,66,77)(H,67,80)(H,68,83)(H,69,82)(H,70,79)(H,71,81)(H4,57,58,60);1H
2.1.3 InChI Key
UPRWQSQENCASAD-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC(C)CC(C(=O)NC(CCCN=C(N)N)C(=O)N1CCCC1C(=O)NCC(=O)N)NC(=O)CNC(=O)C(CC2=CC=C(C=C2)O)NC(=O)C(CO)NC(=O)C(CC3=CNC4=CC=CC=C43)NC(=O)C(CC5=CN=CN5)NC(=O)C6CCC(=O)N6.Cl
2.2 Synonyms
2.2.1 MeSH Synonyms

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

2.2.2 Depositor-Supplied Synonyms

1. Gonadorelin Hydrochloride

2.3 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 1218.7 g/mol
Molecular Formula C55H76ClN17O13
Hydrogen Bond Donor Count17
Hydrogen Bond Acceptor Count15
Rotatable Bond Count31
Exact Mass1217.5497032 g/mol
Monoisotopic Mass1217.5497032 g/mol
Topological Polar Surface Area475 Ų
Heavy Atom Count86
Formal Charge0
Complexity2390
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count8
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2

NDC API

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GONADORELIN HYDROCHLORIDE

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

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GONADORELIN HYDROCHLORIDE

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

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ABOUT THIS PAGE

Gonadorelin Hydrochloride Manufacturers

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.

Gonadorelin Hydrochloride Suppliers

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.

Gonadorelin Hydrochloride USDMF

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.

Gonadorelin Hydrochloride 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 Gonadorelin Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

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.

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 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.

Compounded drug products

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 GMP

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.

Gonadorelin Hydrochloride CoA

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).

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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