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    ACTIVE PHARMA INGREDIENTS

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    Synopsis

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    Chemistry

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    Also known as: 74381-53-6, Leuprorelin acetate;h-pyr-his-trp-ser-tyr-d-leu-leu-arg-pro-nhet.ch3co2h, Lupron (tn), Mfcd00072080, Fensolvi (tn), Eligard (tn)
    Molecular Formula
    C61H88N16O14
    Molecular Weight
    1269.4  g/mol
    InChI Key
    RGLRXNKKBLIBQS-UHFFFAOYSA-N
    Leuprolide Acetate
    1 2D Structure

    Leuprolide Acetate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    acetic acid;N-[1-[[1-[[1-[[1-[[1-[[1-[[5-(diaminomethylideneamino)-1-[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
    2.1.2 InChI
    InChI=1S/C59H84N16O12.C2H4O2/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;1-2(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,3,4)
    2.1.3 InChI Key
    RGLRXNKKBLIBQS-UHFFFAOYSA-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.CC(=O)O
    2.2 Synonyms
    2.2.1 Depositor-Supplied Synonyms

    1. 74381-53-6

    2. Leuprorelin Acetate;h-pyr-his-trp-ser-tyr-d-leu-leu-arg-pro-nhet.ch3co2h

    3. Lupron (tn)

    4. Mfcd00072080

    5. Fensolvi (tn)

    6. Eligard (tn)

    7. Lutrate (tn)

    8. Leuprolide Acetate (usp)

    9. Leuprorelin Acetate (jp17)

    10. Schembl1651429

    11. 5-oxopro-his-trp-ser-tyr-d-leu-leu-arg-pronhc2h5 Dihydrate

    12. Amy12301

    13. Nsc746847

    14. Nsc-746847

    15. Sy225936

    16. Ft-0627807

    17. D00989

    18. Leuprorelin Acetate; Lupron; Leuprolide Acetate

    2.3 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 1269.4 g/mol
    Molecular Formula C61H88N16O14
    Hydrogen Bond Donor Count16
    Hydrogen Bond Acceptor Count16
    Rotatable Bond Count32
    Exact Mass1268.66659154 g/mol
    Monoisotopic Mass1268.66659154 g/mol
    Topological Polar Surface Area469 Ų
    Heavy Atom Count91
    Formal Charge0
    Complexity2420
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count9
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameLeuprolide acetate
    Drug LabelLeuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-s...
    Active IngredientLeuprolide acetate
    Dosage FormInjectable
    RouteInjection
    Strength1mg/0.2ml
    Market StatusPrescription
    CompanyTeva Pharms Usa; Sandoz; Sun Pharma Global

    2 of 2  
    Drug NameLeuprolide acetate
    Drug LabelLeuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-s...
    Active IngredientLeuprolide acetate
    Dosage FormInjectable
    RouteInjection
    Strength1mg/0.2ml
    Market StatusPrescription
    CompanyTeva Pharms Usa; Sandoz; Sun Pharma Global

    API Reference Price

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EUR. USP","address":"VILLAGE NAG KALAN,MAJITHA ROAD,MAJ","city":"AMRITSAR,PUNJAB","supplier":"BACHEM AG","supplierCountry":"SWITZERLAND","foreign_port":"MUNICH","customer":"KWALITY PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.13","actualQuantity":"125","unit":"GMS","unitRateFc":"190","totalValueFC":"25295.5","currency":"USD","unitRateINR":"17003.9","date":"11-Oct-2024","totalValueINR":"2125492.5","totalValueInUsd":"25295.5","indian_port":"Delhi Air","hs_no":"29339990","bill_no":"6077208","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"MUNICH","supplierAddress":"HAUPTSTRASSE 144 CH-4416 BUBENDORF SDNF SDNF","customerAddress":"VILLAGE NAG KALAN,MAJITHA ROAD,MAJ"}]
    16-Jan-2021
    26-Dec-2024
    KGS
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

    Total Value (USD)

    Quantity (KGS) & Unit rate (USD/KGS) over time

    API Imports and Exports

    Importing Country Total Quantity
    (KGS)    		 Average Price
    (USD/KGS)    		 Number of Transactions

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - POWDER;INTRAMUSCULAR - 11.25MG

    USFDA APPLICATION NUMBER - 20263

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    DOSAGE - POWDER;INTRAMUSCULAR - 15MG

    USFDA APPLICATION NUMBER - 20263

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    DOSAGE - POWDER;INTRAMUSCULAR - 3.75MG,7.5MG ...DOSAGE - POWDER;INTRAMUSCULAR - 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20263

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    DOSAGE - POWDER;INTRAMUSCULAR - 30MG

    USFDA APPLICATION NUMBER - 20263

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    DOSAGE - POWDER;INTRAMUSCULAR - 45MG

    USFDA APPLICATION NUMBER - 20263

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    DOSAGE - POWDER;INTRAMUSCULAR - 7.5MG

    USFDA APPLICATION NUMBER - 20263

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    DOSAGE - POWDER;INTRAMUSCULAR - 7.5MG,7.5MG *...DOSAGE - POWDER;INTRAMUSCULAR - 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20263

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    DOSAGE - INJECTABLE, TABLET;INTRAMUSCULAR, OR...DOSAGE - INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG

    USFDA APPLICATION NUMBER - 203696

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    DOSAGE - INJECTABLE, TABLET;INTRAMUSCULAR, OR...DOSAGE - INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 3.75MG/VIAL,N/A;N/A,5MG

    USFDA APPLICATION NUMBER - 203696

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    USP

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    ABOUT THIS PAGE

    Leuprolide Acetate Manufacturers

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

    Leuprolide Acetate Suppliers

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

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

    Leuprolide Acetate USDMF

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

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

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

    Leuprolide Acetate JDMF

    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 Leuprolide Acetate Drug Master File in Japan (Leuprolide Acetate JDMF) empowers Leuprolide Acetate 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 Leuprolide Acetate JDMF during the approval evaluation for pharmaceutical products. At the time of Leuprolide Acetate 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 Leuprolide Acetate suppliers with JDMF on PharmaCompass.

    Leuprolide Acetate KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Leuprolide Acetate Drug Master File in Korea (Leuprolide Acetate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Leuprolide Acetate. The MFDS reviews the Leuprolide Acetate KDMF as part of the drug registration process and uses the information provided in the Leuprolide Acetate KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Leuprolide 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 Leuprolide Acetate API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Leuprolide Acetate suppliers with KDMF on PharmaCompass.

    Leuprolide Acetate CEP

    A Leuprolide Acetate CEP of the European Pharmacopoeia monograph is often referred to as a Leuprolide Acetate Certificate of Suitability (COS). The purpose of a Leuprolide Acetate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Leuprolide Acetate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Leuprolide Acetate to their clients by showing that a Leuprolide Acetate CEP has been issued for it. The manufacturer submits a Leuprolide Acetate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Leuprolide Acetate CEP holder for the record. Additionally, the data presented in the Leuprolide Acetate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Leuprolide Acetate DMF.

    A Leuprolide Acetate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Leuprolide Acetate 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 Leuprolide Acetate suppliers with CEP (COS) on PharmaCompass.

    Leuprolide Acetate WC

    A Leuprolide Acetate written confirmation (Leuprolide Acetate WC) is an official document issued by a regulatory agency to a Leuprolide Acetate manufacturer, verifying that the manufacturing facility of a Leuprolide Acetate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Leuprolide Acetate APIs or Leuprolide Acetate finished pharmaceutical products to another nation, regulatory agencies frequently require a Leuprolide Acetate WC (written confirmation) as part of the regulatory process.

    click here to find a list of Leuprolide Acetate suppliers with Written Confirmation (WC) on PharmaCompass.

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

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Leuprolide Acetate 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 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.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Leuprolide Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Leuprolide Acetate NDC to their finished compounded human drug products, they may choose to do so.

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

    Leuprolide Acetate GMP

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

    Leuprolide Acetate CoA

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

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

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