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    Chemistry

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    Also known as: 129311-55-3, Ganirelix acetate [usan], Ganirelix acetate injection, Antagon, 56u7906fqw, Orgalutran
    Molecular Formula
    C84H121ClN18O17
    Molecular Weight
    1690.4  g/mol
    InChI Key
    OVBICQMTCPFEBS-SATRDZAXSA-N
    FDA UNII
    56U7906FQW
    Ganirelix
    Ganirelix Acetate is the acetate salt form of ganirelix, a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotropin-releasing hormone (GnRH). Ganirelix directly competes with the GnRH for receptor binding in the anterior pituitary gland, thus induces a rapid and reversible suppression of the release of follicle stimulating hormone (FSH) and luteinizing hormone (LH). This agent is used for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation, and in combination with other hormones for retrieval of the mature follicles for in-vitro fertilization.
    1 2D Structure

    Ganirelix

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2S)-1-[(2S)-2-[[(2S)-2-[[(2R)-2-[[(2S)-2-[[(2S)-2-[[(2R)-2-[[(2R)-2-[[(2R)-2-acetamido-3-naphthalen-2-ylpropanoyl]amino]-3-(4-chlorophenyl)propanoyl]amino]-3-pyridin-3-ylpropanoyl]amino]-3-hydroxypropanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-6-[bis(ethylamino)methylideneamino]hexanoyl]amino]-4-methylpentanoyl]amino]-6-[bis(ethylamino)methylideneamino]hexanoyl]-N-[(2R)-1-amino-1-oxopropan-2-yl]pyrrolidine-2-carboxamide;acetic acid
    2.1.2 InChI
    InChI=1S/C80H113ClN18O13.2C2H4O2/c1-9-84-79(85-10-2)88-38-17-15-24-60(70(104)94-62(41-49(5)6)71(105)93-61(25-16-18-39-89-80(86-11-3)87-12-4)78(112)99-40-20-26-68(99)77(111)90-50(7)69(82)103)92-73(107)64(44-53-30-35-59(102)36-31-53)97-76(110)67(48-100)98-75(109)66(46-55-21-19-37-83-47-55)96-74(108)65(43-52-28-33-58(81)34-29-52)95-72(106)63(91-51(8)101)45-54-27-32-56-22-13-14-23-57(56)42-54;2*1-2(3)4/h13-14,19,21-23,27-37,42,47,49-50,60-68,100,102H,9-12,15-18,20,24-26,38-41,43-46,48H2,1-8H3,(H2,82,103)(H,90,111)(H,91,101)(H,92,107)(H,93,105)(H,94,104)(H,95,106)(H,96,108)(H,97,110)(H,98,109)(H2,84,85,88)(H2,86,87,89);2*1H3,(H,3,4)/t50-,60-,61+,62+,63-,64+,65-,66-,67+,68+;;/m1../s1
    2.1.3 InChI Key
    OVBICQMTCPFEBS-SATRDZAXSA-N
    2.1.4 Canonical SMILES
    CCNC(=NCCCCC(C(=O)NC(CC(C)C)C(=O)NC(CCCCN=C(NCC)NCC)C(=O)N1CCCC1C(=O)NC(C)C(=O)N)NC(=O)C(CC2=CC=C(C=C2)O)NC(=O)C(CO)NC(=O)C(CC3=CN=CC=C3)NC(=O)C(CC4=CC=C(C=C4)Cl)NC(=O)C(CC5=CC6=CC=CC=C6C=C5)NC(=O)C)NCC.CC(=O)O.CC(=O)O
    2.1.5 Isomeric SMILES
    CCNC(=NCCCC[C@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN=C(NCC)NCC)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(=O)N)NC(=O)[C@H](CC2=CC=C(C=C2)O)NC(=O)[C@H](CO)NC(=O)[C@@H](CC3=CN=CC=C3)NC(=O)[C@@H](CC4=CC=C(C=C4)Cl)NC(=O)[C@@H](CC5=CC6=CC=CC=C6C=C5)NC(=O)C)NCC.CC(=O)O.CC(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    56U7906FQW
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Antagon

    2. Ganirelix

    3. Ganirelix Diacetate

    4. Gnrh, N-ac-2-nal(1)-4-cl-phe(2)-3-pal(3)-et2-harg(6,8)-alanh2(10)-

    5. Lhrh, N-acetyl-2-naphthylalanyl(1)-(4-chlorophenylalanyl)(2)-3-pyrdinylalanyl(3)-diethylhomoarginyl(6,8)-alaninamide(10)-

    6. Lhrh,n-ac-2-nal(1)-4-cl-phe(2)-3-pal(3)-et2-harg(6,8)-alanh2(10)-

    7. N-ac-(2-naphthyl)ala-2-(4-cl-phe)-3-(3-pyridinyl-ala)-6,8-et2-harg-10-alanh2-lhrh

    8. N-acetyl-3-(2-naphthyl)-d-alanyl-p-chloro-d-phenylalanyl-3-(3-pyridyl)-d-alanyl-l-seryl-l-tyrosyl-n(sup 6)-(n,n'-diethylamidino)-d-lysyl-l-leucyl-n(sup 6)-(n,n'-diethylamidino)-l-lysyl-l-prolyl-d-alaninamide Diacetate (salt)

    9. Orgalutran

    10. Rs 26306

    11. Rs-26306

    12. Rs-26306-298

    2.3.2 Depositor-Supplied Synonyms

    1. 129311-55-3

    2. Ganirelix Acetate [usan]

    3. Ganirelix Acetate Injection

    4. Antagon

    5. 56u7906fqw

    6. Orgalutran

    7. Rs-26306

    8. Ganirelix (acetate)

    9. Ganirest

    10. D-alaninamide,n-acetyl-3-(2-naphthalenyl)-d-alanyl-4-chloro-d-phenylalanyl-3-(3-pyridinyl)-d-alanyl-l-seryl-l-tyrosyl-n6-[bis(ethylamino)methylene]-d-lysyl-l-leucyl-n6-[bis(ethylamino)methylene]-l-lysyl-l-prolyl-, Diacetate (salt)

    11. N-acetyl-3-(2-naphthyl)-d-alanyl-p-chloro-d-phenylalanyl-3-(3-pyridyl)-d-alanyl-l-seryl-l-tyrosyl-n(sup 6)-(n,n'-diethylamidino)-d-lysyl-l-leucyl-n(sup 6)-(n,n'-diethylamidino)-l-lysyl-l-prolyl-d-alaninamide Diacetate (salt)

    12. Rs-26306-298

    13. Unii-56u7906fqw

    14. Ganirest (tn)

    15. Orgalutran Tfa Salt

    16. Ganirelix Acetate [mi]

    17. Ganirelix Acetate (jan/usan)

    18. Ganirelix Acetate [jan]

    19. Org-37462

    20. Ganirelix Acetate [vandf]

    21. Ganirelix Acetate Injection (tn)

    22. Ganirelix Acetate [mart.]

    23. Ganirelix Acetate [who-dd]

    24. Akos025394292

    25. Ganirelix Acetate [orange Book]

    26. Hy-109532

    27. D04302

    28. 311g553

    29. J-005666

    30. Q27261435

    31. D-alaninamide, N-acetyl-3-(2-naphthalenyl)-d-alanyl-4-chloro-d-phenylalanyl-3-(3-pyridinyl)-d-alanyl-l-seryl-l-tyrosyl-n(sup 6)-((ethylamino)(ethylimino)methyl)-d-lysyl-l-leucyl-n(sup 6)-((ethylamino)(ethylimino)methyl)-l-lysyl-l-prolyl-, Diacetate (salt)

    2.4 Create Date
    2008-02-08
    3 Chemical and Physical Properties
    Molecular Weight 1690.4 g/mol
    Molecular Formula C84H121ClN18O17
    Hydrogen Bond Donor Count18
    Hydrogen Bond Acceptor Count20
    Rotatable Bond Count48
    Exact Mass1688.8845622 g/mol
    Monoisotopic Mass1688.8845622 g/mol
    Topological Polar Surface Area526 Ų
    Heavy Atom Count120
    Formal Charge0
    Complexity3060
    Isotope Atom Count0
    Defined Atom Stereocenter Count10
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameGanirelix acetate
    Drug LabelGanirelix Acetate Injection is a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotropin-releasing hormone (GnRH). Ganirelix Acetate is derived from native GnRH with substitutions of amino acids at positions 1,...
    Active IngredientGanirelix acetate
    Dosage FormInjectable
    RouteInjection
    Strengtheq 250mcg base/0.5ml
    Market StatusPrescription
    CompanyOrganon Usa

    2 of 2  
    Drug NameGanirelix acetate
    Drug LabelGanirelix Acetate Injection is a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotropin-releasing hormone (GnRH). Ganirelix Acetate is derived from native GnRH with substitutions of amino acids at positions 1,...
    Active IngredientGanirelix acetate
    Dosage FormInjectable
    RouteInjection
    Strengtheq 250mcg base/0.5ml
    Market StatusPrescription
    CompanyOrganon Usa

    4.2 Drug Indication

    The prevention of premature luteinising-hormone surges in women undergoing controlled ovarian hyperstimulation for assisted reproduction techniques.

    In clinical studies, Orgalutran was used with recombinant human follicle-stimulating hormone or corifollitropin alfa, the sustained follicle stimulant.

    Prevention of premature luteinising hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Hormone Antagonists

    Chemical substances which inhibit the function of the endocrine glands, the biosynthesis of their secreted hormones, or the action of hormones upon their specific sites. (See all compounds classified as Hormone Antagonists.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Gonadotropin Releasing Hormone Receptor Antagonist [EPC]; Gonadotropin Releasing Hormone Receptor Antagonists [MoA]; Decreased GnRH Secretion [PE]
    5.3 ATC Code

    H01CC01

    H01CC01

    API Reference Price

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SUKUN BUNGLOW, SOLA","city":"AHMEDABAD,GUJARAT","supplier":"BCN PEPTIDES","supplierCountry":"SPAIN","foreign_port":"NA","customer":"AMERISE PHARMACEUTICALS PRIVATE ","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00002","unit":"KGS","unitRateFc":"15000000","totalValueFC":"320","currency":"EUR","unitRateINR":"1236750000","date":"18-May-2022","totalValueINR":"24735","totalValueInUsd":"320","indian_port":"AHMEDABAD AIR","hs_no":"29371900","bill_no":"8729094","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B1-14,GALAXY SIGNATURE,SCIENCE CIT Y,ROAD, OPP. SUKUN BUNGLOW, SOLA"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1652812200,"product":"IMPGA2 L-PHE(4-CI)(2)-GANIRELIX, LOT NO:L-F4CI2-GA-21X1 (0.020 GMS)","address":"B1-14,GALAXY SIGNATURE,SCIENCE CIT Y,ROAD, OPP. SUKUN BUNGLOW, SOLA","city":"AHMEDABAD,GUJARAT","supplier":"BCN PEPTIDES","supplierCountry":"SPAIN","foreign_port":"NA","customer":"AMERISE PHARMACEUTICALS PRIVATE ","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00002","unit":"KGS","unitRateFc":"15000000","totalValueFC":"320","currency":"EUR","unitRateINR":"1236750000","date":"18-May-2022","totalValueINR":"24735","totalValueInUsd":"320","indian_port":"AHMEDABAD AIR","hs_no":"29371900","bill_no":"8729094","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B1-14,GALAXY SIGNATURE,SCIENCE CIT Y,ROAD, OPP. SUKUN BUNGLOW, SOLA"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1652812200,"product":"IMPGA6 L-HARG(ET)2(6)-GANIRELIX, LOT NO:LHARGET26GA21X1 (0.020 GMS)","address":"B1-14,GALAXY SIGNATURE,SCIENCE CIT Y,ROAD, OPP. SUKUN BUNGLOW, SOLA","city":"AHMEDABAD,GUJARAT","supplier":"BCN PEPTIDES","supplierCountry":"SPAIN","foreign_port":"NA","customer":"AMERISE PHARMACEUTICALS PRIVATE ","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00002","unit":"KGS","unitRateFc":"15000000","totalValueFC":"320","currency":"EUR","unitRateINR":"1236750000","date":"18-May-2022","totalValueINR":"24735","totalValueInUsd":"320","indian_port":"AHMEDABAD AIR","hs_no":"29371900","bill_no":"8729094","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B1-14,GALAXY SIGNATURE,SCIENCE CIT Y,ROAD, OPP. SUKUN BUNGLOW, SOLA"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1652812200,"product":"IMPGA8 D-HARG(ET)2(8)-GANIRELIX, LOT NO:DHARGET28GA21X1 (0.020 GMS)","address":"B1-14,GALAXY SIGNATURE,SCIENCE CIT Y,ROAD, OPP. SUKUN BUNGLOW, SOLA","city":"AHMEDABAD,GUJARAT","supplier":"BCN PEPTIDES","supplierCountry":"SPAIN","foreign_port":"NA","customer":"AMERISE PHARMACEUTICALS PRIVATE ","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00002","unit":"KGS","unitRateFc":"15000000","totalValueFC":"320","currency":"EUR","unitRateINR":"1236750000","date":"18-May-2022","totalValueINR":"24735","totalValueInUsd":"320","indian_port":"AHMEDABAD AIR","hs_no":"29371900","bill_no":"8729094","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B1-14,GALAXY SIGNATURE,SCIENCE CIT Y,ROAD, OPP. SUKUN BUNGLOW, SOLA"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1652812200,"product":"IMPGA9 D-PRO(9)-GANIRELIX, LOT NO:D-PRO(9)-GA21X1 (0.020 GMS)","address":"B1-14,GALAXY SIGNATURE,SCIENCE CIT Y,ROAD, OPP. SUKUN BUNGLOW, SOLA","city":"AHMEDABAD,GUJARAT","supplier":"BCN PEPTIDES","supplierCountry":"SPAIN","foreign_port":"NA","customer":"AMERISE PHARMACEUTICALS PRIVATE ","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00002","unit":"KGS","unitRateFc":"15000000","totalValueFC":"320","currency":"EUR","unitRateINR":"1236750000","date":"18-May-2022","totalValueINR":"24735","totalValueInUsd":"320","indian_port":"AHMEDABAD AIR","hs_no":"29371900","bill_no":"8729094","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B1-14,GALAXY SIGNATURE,SCIENCE CIT Y,ROAD, OPP. SUKUN BUNGLOW, SOLA"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1656095400,"product":"GANIRELIX ACETATE STANDARD (QTY-600MG)","address":"Part of Plot No.11 & 87, Sy No.119 Phase - IV, Extension in IP, Pasham","city":"HYDERABAD","supplier":"HYBIO PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"NA","customer":"GLAND PHARMA LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0006","unit":"KGS","unitRateFc":"17500000","totalValueFC":"12753.1","currency":"USD","unitRateINR":"1658228517","date":"25-Jun-2022","totalValueINR":"994937.11","totalValueInUsd":"12753.1","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"9278337","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"Part of Plot No.11 & 87, Sy No.119 Phase - IV, Extension in IP, Pasham"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1676917800,"product":"GANIRELIX ACETATE","address":"Part of Plot No.11 & 87, Sy No.119 Phase - IV, Extension in IP, Pasham","city":"HYDERABAD","supplier":"HYBIO PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"NA","customer":"GLAND PHARMA LIMITED","customerCountry":"INDIA","quantity":"0.03","actualQuantity":"27","unit":"GMS","unitRateFc":"6054.5","totalValueFC":"166813.8","currency":"USD","unitRateINR":"510265","date":"21-Feb-2023","totalValueINR":"13777155","totalValueInUsd":"166813.8","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"4742745","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"Part of Plot No.11 & 87, Sy No.119 Phase - IV, Extension in IP, Pasham"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712687400,"product":"GANIRELIX ACETATE","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"HYBIO PHARMACEUTICAL (WUHAN) CO., LTD.","supplierCountry":"CHINA","foreign_port":"N\/A","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"0.07","actualQuantity":"74","unit":"GMS","unitRateFc":"3905.8","totalValueFC":"291945.3","currency":"USD","unitRateINR":"329453.6","date":"10-Apr-2024","totalValueINR":"24379566","totalValueInUsd":"291945.3","indian_port":"M\/s MAHARASHTRA AIRPORT DEVELOPMENTCOMPANYLIMITED","hs_no":"29371900","bill_no":"1000700","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"N\/A","customerAddress":"159, C.S.T. ROAD,"}]
    14-Jan-2021
    10-Apr-2024
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    Egypt.png
    Various APIs needed in Egypt [ENA16647]
    A company that focuses on topicals, oral liquids and solutions is looking for suppliers of Various APIs for commercial purposes. The suppliers must support this enquiry with GMP & CoA. 1. Alirocumab API 2. Omalizumab API 3. Ganirelix API 4. Bemiparin Sodium API 5. Mepolizumab API 6. Denosumab API 7. Lanreotide Acetate API 8. Ph. Eur./ BP/ USP Grade Octreotide Acetate API 9. Darbepoetin Alfa API 10. Adalimumab API
    18 Mar 2023

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    18 Mar 2023

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    18 Mar 2023

    Slovakia.png
    Ganirelix Acetate (200 g) API needed in Slovakia [ENA12505]
    A largest pharmaceutical company that deals in R&D and production of APIs & finished products includes analytical & galenical development is looking for suppliers of Ganirelix Acetate (200 g) API for development purpose. The suppliers must support this enquiry with GMP & CoA.
    25 Jan 2022

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    25 Jan 2022

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    25 Jan 2022

    United_States_of_America.png
    Ganirelix Acetate (60 g) API needed in the US [ENA11198]
    A fully licensed and certified distributor dealing in pharmaceutical components for the health and veterinary industries is looking for suppliers of Ganirelix Acetate (60 g) API for development purpose.
    24 Aug 2021

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    24 Aug 2021

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    24 Aug 2021

    Australia.png
    Ganirelix Acetate (50-100 g) API needed in Australia [ENA05152]
    A licensed contract manufacturing company with the latest technology and equipment to ensure the manufacturing of high quality novel drug delivery systems such as oral sublingual wafers, conventional oral solid and liquid dosage forms is looking for suppliers of Ganirelix Acetate (50-100 g) API. The supplier must support this enquiry with GMP.
    13 Sep 2019

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    13 Sep 2019

    Market Place
    Enquiry// Ganirelix Acetate API 3-5 g per year needed in Iran [ENA00741]
    A privately owned pharmaceutical company established as a knowledge-based company in 2009 is looking for suppliers/manufacturers of Ganirelix Acetate API 3-5 g per year for domestic consumption. Their current requirement is 1 g sample.
    28 Feb 2018

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    28 Feb 2018

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    28 Feb 2018

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    Patents & EXCLUSIVITIES

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    REF. STANDARDS & IMPURITIES

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    ABOUT THIS PAGE

    Ganirelix Acetate Manufacturers

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

    Ganirelix Acetate Suppliers

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

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

    Ganirelix Acetate USDMF

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

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

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

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

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

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

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

    Ganirelix Acetate WC

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

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

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

    Finished drug products

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

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

    Ganirelix Acetate GMP

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

    Ganirelix Acetate CoA

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

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

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