Find Leuprolide Mesylate manufacturers, exporters & distributors on PharmaCompass

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Chemistry

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Also known as: Leuprorelin mesilate, Leuprorelin mesylate, Camcevi, 8e3c3c493w, Pglu-his-trp-ser-tyr-d-leu-leu-arg-pro-nhc2h5 mesylate, Pglu-his-trp-ser-tyr-d-leu-leu-arg-pro-nhc2h5 methanesulfonate
Molecular Formula
C60H88N16O15S
Molecular Weight
1305.5  g/mol
InChI Key
MBIDSOMXPLCOHS-XNHQSDQCSA-N
FDA UNII
8E3C3C493W

Leuprolide Mesylate
1 2D Structure

Leuprolide Mesylate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S)-N-[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2R)-1-[[(2S)-1-[[(2S)-5-(diaminomethylideneamino)-1-[(2S)-2-(ethylcarbamoyl)pyrrolidin-1-yl]-1-oxopentan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]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;methanesulfonic acid
2.1.2 InChI
InChI=1S/C59H84N16O12.CH4O3S/c1-6-63-57(86)48-14-10-22-75(48)58(87)41(13-9-21-64-59(60)61)68-51(80)42(23-32(2)3)69-52(81)43(24-33(4)5)70-53(82)44(25-34-15-17-37(77)18-16-34)71-56(85)47(30-76)74-54(83)45(26-35-28-65-39-12-8-7-11-38(35)39)72-55(84)46(27-36-29-62-31-66-36)73-50(79)40-19-20-49(78)67-40;1-5(2,3)4/h7-8,11-12,15-18,28-29,31-33,40-48,65,76-77H,6,9-10,13-14,19-27,30H2,1-5H3,(H,62,66)(H,63,86)(H,67,78)(H,68,80)(H,69,81)(H,70,82)(H,71,85)(H,72,84)(H,73,79)(H,74,83)(H4,60,61,64);1H3,(H,2,3,4)/t40-,41-,42-,43+,44-,45-,46-,47-,48-;/m0./s1
2.1.3 InChI Key
MBIDSOMXPLCOHS-XNHQSDQCSA-N
2.1.4 Canonical SMILES
CCNC(=O)C1CCCN1C(=O)C(CCCN=C(N)N)NC(=O)C(CC(C)C)NC(=O)C(CC(C)C)NC(=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.CS(=O)(=O)O
2.1.5 Isomeric SMILES
CCNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCN=C(N)N)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CC(C)C)NC(=O)[C@H](CC2=CC=C(C=C2)O)NC(=O)[C@H](CO)NC(=O)[C@H](CC3=CNC4=CC=CC=C43)NC(=O)[C@H](CC5=CN=CN5)NC(=O)[C@@H]6CCC(=O)N6.CS(=O)(=O)O
2.2 Other Identifiers
2.2.1 UNII
8E3C3C493W
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. Leuprorelin Mesilate

2. Leuprorelin Mesylate

3. Camcevi

4. 8e3c3c493w

5. Pglu-his-trp-ser-tyr-d-leu-leu-arg-pro-nhc2h5 Mesylate

6. Pglu-his-trp-ser-tyr-d-leu-leu-arg-pro-nhc2h5 Methanesulfonate

7. 1-9-luteinizing Hormone-releasing Factor (swine), 6-d-leucine-9-(n-ethyl-l-prolinamide)-, Methanesulfonate (1:1)

8. 944347-41-5

9. Unii-8e3c3c493w

10. Schembl4075500

11. Chembl4802223

12. Leuprorelin Mesilate [who-dd]

13. Leuprolide Mesylate [orange Book]

14. Q27270242

2.4 Create Date
2014-05-03
3 Chemical and Physical Properties
Molecular Weight 1305.5 g/mol
Molecular Formula C60H88N16O15S
Hydrogen Bond Donor Count16
Hydrogen Bond Acceptor Count17
Rotatable Bond Count32
Exact Mass1304.63357734 g/mol
Monoisotopic Mass1304.63357734 g/mol
Topological Polar Surface Area494 Ų
Heavy Atom Count92
Formal Charge0
Complexity2480
Isotope Atom Count0
Defined Atom Stereocenter Count9
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Indication

Camcevi is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.


NDC API

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Bioequity Europe
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LEUPROLIDE MESYLATE

NDC Package Code : 65129-1317

Start Marketing Date : 2012-10-22

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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Bachem AG

Switzerland
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

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Leuprolide Mesylate

About the Company : With more than 50 years of experience and expertise, Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology comp...

With more than 50 years of experience and expertise, Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide, providing a wide range of services. Over the years, Bachem has established itself as a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. The company is headquartered in Switzerland and has offices in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange.
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02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

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Leuprolide Mesylate

About the Company : Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically...

Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integrated company, we focus on developing high-quality formulations based on in-house-produced actives. With GMP-certified facilities and partnerships with contract manufacturers, we excel in formulation development for injectables, lyophilized injectables, complex generics, and oral peptide delivery systems, ensuring affordable, top-quality medicines.
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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.

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Leuprolide Mesylate

About the Company : Sumar Biotech LLP, registered in January 2018, is a startup approved by the Gujarat State Biotechnology Mission. It was founded by emerging entrepreneurs and a team of young yet ex...

Sumar Biotech LLP, registered in January 2018, is a startup approved by the Gujarat State Biotechnology Mission. It was founded by emerging entrepreneurs and a team of young yet experienced research scientists and manufacturing professionals. We work together to innovate and manufacture semi-synthetic, synthetic, and fermentation-based APIs. Our R&D facility is equipped with state-of-the-art technology for synthesis, extraction, isolation, and purification of products from the upstream (fermentation) process. Our team is also involved in developing and implementing new ideas in process chemistry for various therapeutic molecules.
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API Reference Price

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23-Jun-2021
29-Dec-2023
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FDF Dossiers

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Accord healthcare

United Kingdom
CST
Not Confirmed
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Accord healthcare

United Kingdom
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Not Confirmed

LEUPROLIDE MESYLATE

Brand Name : CAMCEVI KIT

Dosage Form : EMULSION;SUBCUTANEOUS

Dosage Strength : EQ 42MG BASE

Packaging :

Approval Date : 2021-05-25

Application Number : 211488

Regulatory Info : RX

Registration Country : USA

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Looking for 944347-41-5 / Leuprolide Mesylate API manufacturers, exporters & distributors?

Leuprolide Mesylate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Leuprolide Mesylate 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 Leuprolide Mesylate manufacturer or Leuprolide Mesylate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Leuprolide Mesylate manufacturer or Leuprolide Mesylate supplier.

PharmaCompass also assists you with knowing the Leuprolide Mesylate API Price utilized in the formulation of products. Leuprolide Mesylate API Price is not always fixed or binding as the Leuprolide Mesylate Price is obtained through a variety of data sources. The Leuprolide Mesylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Leuprolide Mesylate

Synonyms

Leuprorelin mesilate, Leuprorelin mesylate, Camcevi, 8e3c3c493w, Pglu-his-trp-ser-tyr-d-leu-leu-arg-pro-nhc2h5 mesylate, Pglu-his-trp-ser-tyr-d-leu-leu-arg-pro-nhc2h5 methanesulfonate

Cas Number

944347-41-5

Unique Ingredient Identifier (UNII)

8E3C3C493W

Leuprolide Mesylate Manufacturers

A Leuprolide Mesylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Leuprolide Mesylate, including repackagers and relabelers. The FDA regulates Leuprolide Mesylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Leuprolide Mesylate 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 Leuprolide Mesylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Leuprolide Mesylate Suppliers

A Leuprolide Mesylate supplier is an individual or a company that provides Leuprolide Mesylate active pharmaceutical ingredient (API) or Leuprolide Mesylate finished formulations upon request. The Leuprolide Mesylate suppliers may include Leuprolide Mesylate API manufacturers, exporters, distributors and traders.

click here to find a list of Leuprolide Mesylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Leuprolide Mesylate USDMF

A Leuprolide Mesylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Leuprolide Mesylate active pharmaceutical ingredient (API) in detail. Different forms of Leuprolide Mesylate DMFs exist exist since differing nations have different regulations, such as Leuprolide Mesylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Leuprolide Mesylate DMF submitted to regulatory agencies in the US is known as a USDMF. Leuprolide Mesylate USDMF includes data on Leuprolide Mesylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Leuprolide Mesylate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Leuprolide Mesylate suppliers with USDMF on PharmaCompass.

Leuprolide Mesylate 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 Leuprolide Mesylate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Leuprolide Mesylate 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 Leuprolide Mesylate 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 Leuprolide Mesylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Leuprolide Mesylate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Leuprolide Mesylate suppliers with NDC on PharmaCompass.

Leuprolide Mesylate GMP

Leuprolide Mesylate 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 Leuprolide Mesylate 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 Leuprolide Mesylate GMP manufacturer or Leuprolide Mesylate GMP API supplier for your needs.

Leuprolide Mesylate CoA

A Leuprolide Mesylate CoA (Certificate of Analysis) is a formal document that attests to Leuprolide Mesylate's compliance with Leuprolide Mesylate specifications and serves as a tool for batch-level quality control.

Leuprolide Mesylate CoA mostly includes findings from lab analyses of a specific batch. For each Leuprolide Mesylate 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.

Leuprolide Mesylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Leuprolide Mesylate EP), Leuprolide Mesylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Leuprolide Mesylate 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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