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    Chemistry

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    Also known as: Granisetron hcl, 107007-99-8, Granisetron (hydrochloride), Nsc-759839, 1-methyl-n-(9-methyl-9-azabicyclo[3.3.1]nonan-3-yl)indazole-3-carboxamide;hydrochloride, 1-methyl-1h-indazole-3-carboxylic acid (9-methyl-9-aza-bicyclo[3.3.1]non-3-yl)-amide hydrochloride
    Molecular Formula
    C18H25ClN4O
    Molecular Weight
    348.9  g/mol
    InChI Key
    QYZRTBKYBJRGJB-UHFFFAOYSA-N
    Granisetron Hydrochloride
    A serotonin receptor (5HT-3 selective) antagonist that has been used as an antiemetic for cancer chemotherapy patients.
    1 2D Structure

    Granisetron Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    1-methyl-N-(9-methyl-9-azabicyclo[3.3.1]nonan-3-yl)indazole-3-carboxamide;hydrochloride
    2.1.2 InChI
    InChI=1S/C18H24N4O.ClH/c1-21-13-6-5-7-14(21)11-12(10-13)19-18(23)17-15-8-3-4-9-16(15)22(2)20-17;/h3-4,8-9,12-14H,5-7,10-11H2,1-2H3,(H,19,23);1H
    2.1.3 InChI Key
    QYZRTBKYBJRGJB-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CN1C2CCCC1CC(C2)NC(=O)C3=NN(C4=CC=CC=C43)C.Cl
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. 1-methyl-n-(endo-9-methyl-9-azabicyclo(3.3.1)non-3-yl)-1h-indazole-3-carboxamide

    2. 1h-indazole-3-carboxamide, 1-methyl-n-(9-methyl-9-azabicyclo(3.3.1)non-3-yl

    3. 1h-indazole-3-carboxamide, 1-methyl-n-(9-methyl-9-azabicyclo(3.3.1)non-3-yl)-, Endo-

    4. Brl 43694

    5. Brl 43694a

    6. Brl-43694

    7. Brl-43694a

    8. Brl43694

    9. Brl43694a

    10. Granisetron

    11. Granisetron Monohydrochloride

    12. Hydrochloride, Granisetron

    13. Kytril

    14. Monohydrochloride, Granisetron

    2.2.2 Depositor-Supplied Synonyms

    1. Granisetron Hcl

    2. 107007-99-8

    3. Granisetron (hydrochloride)

    4. Nsc-759839

    5. 1-methyl-n-(9-methyl-9-azabicyclo[3.3.1]nonan-3-yl)indazole-3-carboxamide;hydrochloride

    6. 1-methyl-1h-indazole-3-carboxylic Acid (9-methyl-9-aza-bicyclo[3.3.1]non-3-yl)-amide Hydrochloride

    7. Bema Granisetron

    8. 1-methyl-n-(9-methyl-9-azabicyclo[3.3.1]non-3-yl)-1h-indazole-3-carboxamide Hydrochloride

    9. 1-methyl-n-[(3-endo)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1h-indazole-3-carboxamide Hydrochloride

    10. Granisetronhydrochloride

    11. Granisetron (as Hydrochloride)

    12. C18h24n4o.hcl

    13. 1-methyl-n-(9-methyl-9-azabicyclo[3.3.1]nonan-3-yl)indazole-3-carboxamide Hydrochloride

    14. Schembl33433

    15. Mls003915623

    16. Chembl1237080

    17. Hy-b0071a

    18. 1-methyl-n-(9-methyl-9-azabicyclo[3.3.1]non-3-yl)-indazole-3-carboxamide Hydrochloride

    19. Brl-43694a

    20. Pharmakon1600-01502365

    21. Bcp02186

    22. Tox21_501173

    23. Ac-478

    24. Mfcd21091183

    25. Nsc672814

    26. Nsc759839

    27. S1345

    28. Akos015894931

    29. Ab53971

    30. Ccg-213056

    31. Cs-1510

    32. Lp01173

    33. Nsc-672814

    34. 1-methyl-n-(9-methyl-9-azabicyclo[3.3.1]non-3-yl)-indazole-3-carboxamide Hcl

    35. Ncgc00261858-01

    36. 1044956-47-9

    37. As-12882

    38. Smr001456513

    39. Ft-0626806

    40. J-001688

    2.3 Create Date
    2005-03-26
    3 Chemical and Physical Properties
    Molecular Weight 348.9 g/mol
    Molecular Formula C18H25ClN4O
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count2
    Exact Mass348.1716891 g/mol
    Monoisotopic Mass348.1716891 g/mol
    Topological Polar Surface Area50.2 Ų
    Heavy Atom Count24
    Formal Charge0
    Complexity442
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count2
    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 NameGranisetron hydrochloride
    Drug LabelGranisetron Hydrochloride Tablets USP contain granisetron hydrochloride USP, an antinauseant and antiemetic agent. Chemically it is endo-N-(9-methyl-9-azabicyclo [3.3.1] non-3-yl)-1-methyl-1H-indazole-3-carboxamide hydrochloride with a molecular weig...
    Active IngredientGranisetron hydrochloride
    Dosage FormTablet; Injectable
    Routeinjection; Injection; Oral
    Strength1mg/ml; eq 0.1mg base/ml (eq 0.1mg base/ml); eq 4mg base/4ml (eq 1mg base/ml); eq 1mg base; eq 1mg base/ml (eq 1mg base/ml)
    Market StatusPrescription
    CompanyCorepharma; Sagent Strides; Dsm Pharms; Apotex; Natco Pharma; Teva Pharms Usa; Taro; Banner Pharmacaps; Sandoz; Cipla; Roxane; Sagent Agila; Teva Pharms; Fresenius Kabi Usa; Hikma Maple; Luitpold; Bedford Labs; Dr Reddys Labs; Wockhardt Usa; Mylan; Orchid

    2 of 2  
    Drug NameGranisetron hydrochloride
    Drug LabelGranisetron Hydrochloride Tablets USP contain granisetron hydrochloride USP, an antinauseant and antiemetic agent. Chemically it is endo-N-(9-methyl-9-azabicyclo [3.3.1] non-3-yl)-1-methyl-1H-indazole-3-carboxamide hydrochloride with a molecular weig...
    Active IngredientGranisetron hydrochloride
    Dosage FormTablet; Injectable
    Routeinjection; Injection; Oral
    Strength1mg/ml; eq 0.1mg base/ml (eq 0.1mg base/ml); eq 4mg base/4ml (eq 1mg base/ml); eq 1mg base; eq 1mg base/ml (eq 1mg base/ml)
    Market StatusPrescription
    CompanyCorepharma; Sagent Strides; Dsm Pharms; Apotex; Natco Pharma; Teva Pharms Usa; Taro; Banner Pharmacaps; Sandoz; Cipla; Roxane; Sagent Agila; Teva Pharms; Fresenius Kabi Usa; Hikma Maple; Luitpold; Bedford Labs; Dr Reddys Labs; Wockhardt Usa; Mylan; Orchid

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Antiemetics

    Drugs used to prevent NAUSEA or VOMITING. (See all compounds classified as Antiemetics.)

    Serotonin 5-HT3 Receptor Antagonists

    Drugs that bind to but do not activate SEROTONIN 5-HT3 RECEPTORS, thereby blocking the actions of SEROTONIN or SEROTONIN 5-HT3 RECEPTOR AGONISTS. (See all compounds classified as Serotonin 5-HT3 Receptor Antagonists.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Serotonin-3 Receptor Antagonist [EPC]; Serotonin 3 Receptor Antagonists [MoA]

    API Reference Price

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OF","customerCountry":"MALAYSIA","quantity":"0.33","actualQuantity":"0.325","unit":"KGS","unitRateFc":"60000","totalValueFC":"19213.9","currency":"USD","unitRateINR":4936923.5076923072,"date":"15-Apr-2024","totalValueINR":"1604500.14","totalValueInUsd":"19213.9","indian_port":"Bangalore Air","hs_no":"29333990","bill_no":"9134114","productDescription":"API","marketType":"","country":"MALAYSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"MUMBAI CENTRAL,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716921000,"product":"PHARMACEUTICAL RAW MATERIAL GRANISETRONHYDROCHLORIDE BP (GRANISETRON HYDROCHLORIDE BP INJECTABLE) CAS NO. 107007-99-8","address":"314,JANKI CENTRE,PLOT NO.29,","city":"ANDHERI(W) MAHARASHTRA","supplier":"MEHTA PHARMACEUTICAL INDUSTRIES","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"ARAB AFRICAN INTERNATIONAL BANK","customerCountry":"EGYPT","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"9100","totalValueFC":"17906.3","currency":"USD","unitRateINR":746282.80500000005,"date":"29-May-2024","totalValueINR":"1492565.61","totalValueInUsd":"17906.3","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"1250986","productDescription":"API","marketType":"","country":"EGYPT","selfForZScoreResived":"Sterile","supplierPort":"Bombay Air","supplierAddress":"314,JANKI CENTRE,PLOT NO.29,, ANDHERI(W) MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720117800,"product":"GRANISETRON HYDROCHLORIDE BP\/PH EUR, BATCH:FWP240181, MFG DT:MAY2024,RETEST DT:APR2026, ML: NB-110\/78","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"CIPLA","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"EUROFARMA LABORATORIOS S.A","customerCountry":"BRAZIL","quantity":"0.20","actualQuantity":"0.2","unit":"KGS","unitRateFc":"210000","totalValueFC":"41388.3","currency":"USD","unitRateINR":17298460,"date":"05-Jul-2024","totalValueINR":"3459692","totalValueInUsd":"41388.3","indian_port":"Bangalore Air","hs_no":"29333990","bill_no":"2215574","productDescription":"API","marketType":"","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"MUMBAI CENTRAL,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720722600,"product":"GRANISETRON HYDROCHLORIDE BP\/PH EUR,BATCH:FWP240165,MFG DT:MAU2024,RETEST DT:APR2026, ML: NB-110\/78","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"CIPLA","supplierCountry":"INDIA","foreign_port":"ATHENS","customer":"LABOCHEM SA","customerCountry":"GREECE","quantity":"0.06","actualQuantity":"0.055","unit":"KGS","unitRateFc":"87300","totalValueFC":"4629.1","currency":"USD","unitRateINR":7035509.8181818174,"date":"12-Jul-2024","totalValueINR":"386953.04","totalValueInUsd":"4629.1","indian_port":"Bangalore Air","hs_no":"29333990","bill_no":"2378343","productDescription":"API","marketType":"REGULATED MARKET","country":"GREECE","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"MUMBAI CENTRAL,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725215400,"product":"PHARMACEUTICAL RAW MATERIAL GRANISETRON HYDROCHLORIDE BP 2024 (INJECTABLE) CAS NO.107007-99-8","address":"314,JANKI CENTRE,PLOT NO.29,","city":"ANDHERI(W) MAHARASHTRA","supplier":"MEHTA PHARMACEUTICAL INDUSTRIES","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"EGY PHARMA COMPANY","customerCountry":"EGYPT","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"9025","totalValueFC":"26702.4","currency":"USD","unitRateINR":745897.83333333337,"date":"02-Sep-2024","totalValueINR":"2237693.5","totalValueInUsd":"26702.4","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"3686679","productDescription":"API","marketType":"","country":"EGYPT","selfForZScoreResived":"Sterile","supplierPort":"Bombay Air","supplierAddress":"314,JANKI CENTRE,PLOT NO.29,, ANDHERI(W) MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730917800,"product":"GRANISETRON HYDROCHLORIDE PH.EUR. (APPENDIX 4R,RODTEP ENTRY NO:9538)(OUR REF(S)CI NO:524089)","address":"NATCO HOUSE, ROAD NO.2,","city":"HYDERABAD, A.P.","supplier":"NATCO PHARMA","supplierCountry":"INDIA","foreign_port":"HANNOVER","customer":"SIEGFRIED AG","customerCountry":"GERMANY","quantity":"0.70","actualQuantity":"0.7","unit":"KGS","unitRateFc":"51030","totalValueFC":"35055.4","currency":"USD","unitRateINR":4226091.7142857146,"date":"07-Nov-2024","totalValueINR":"2958264.2","totalValueInUsd":"35055.4","indian_port":"Hyderabad Air","hs_no":"29213090","bill_no":"5425521","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"NATCO HOUSE, ROAD NO.2,, HYDERABAD, A.P.","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1670956200,"product":"GRANISETRON HYDROCHLORIDE. B\/N:323-220506(596G)&323-220507( 590G) MFG. DT.30\/05\/2022 EXP. DT.29\/05\/2025 (1186 G) (TL NO.","address":"UNISON HOUSE, NR. PRERNATIRTH DER NR. RATNADEEP-2, SATELLITE, JODHPUR","city":"AHMEDABAD","supplier":"WUHAN BIOCAUSE PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"NA","customer":"UNISON PHARMACEUTICALS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"1.19","actualQuantity":"1.186","unit":"KGS","unitRateFc":"37000","totalValueFC":"43665.7","currency":"USD","unitRateINR":"3034000","date":"14-Dec-2022","totalValueINR":"3598324","totalValueInUsd":"43665.7","indian_port":"AHMEDABAD AIR","hs_no":"29339990","bill_no":"3733014","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"UNISON HOUSE, NR. PRERNATIRTH DER NR. RATNADEEP-2, SATELLITE, JODHPUR"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1677868200,"product":"GRANISETRON HYDROCHLORIDE (QTY:1 X 0.9 GMS, PRICE USD:72.11)(FOC)","address":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,","city":"TURKAPALLY-V SHAMIRPET HYDERABAD,TE","supplier":"UNITED STATES PHARMACOPEIAL ","supplierCountry":"INDIA","foreign_port":"NA","customer":"UNITED STATES PHARMACOPEIA ","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0009","unit":"KGS","unitRateFc":"80122.2","totalValueFC":"75.7","currency":"USD","unitRateINR":"6914655.6","date":"04-Mar-2023","totalValueINR":"6223.19","totalValueInUsd":"75.7","indian_port":"HYDERABAD AIR","hs_no":"29333990","bill_no":"4914208","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1677868200,"product":"GRANISETRON HYDROCHLORIDE (QTY:2 X 150 MG, PRICE USD:589\/EACH)(FOC)","address":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,","city":"TURKAPALLY-V SHAMIRPET HYDERABAD,TE","supplier":"UNITED STATES PHARMACOPEIAL ","supplierCountry":"INDIA","foreign_port":"NA","customer":"UNITED STATES PHARMACOPEIA ","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0003","unit":"KGS","unitRateFc":"3926666.7","totalValueFC":"1236","currency":"USD","unitRateINR":"338876666.7","date":"04-Mar-2023","totalValueINR":"101663","totalValueInUsd":"1236","indian_port":"HYDERABAD AIR","hs_no":"29333990","bill_no":"4914208","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1714329000,"product":"GRANISETRON HYDROCHLORIDE PH.EUR DMF B.NO:GR-202311101 (250GRAM\/65.00\/GRAM USD)","address":"CLARIS CORPORATE HEAD QUARTERS,","city":"ELLISBRIDGE,AHMEDABD,GUJARAT,INDIA","supplier":"CHONGQING CARELIFE PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"CHENGDU","customer":"BAXTER HEALTHCARE CORPORATION","customerCountry":"INDIA","quantity":"0.25","actualQuantity":"0.25","unit":"KGS","unitRateFc":"65000","totalValueFC":"16423.7","currency":"USD","unitRateINR":"5486000","date":"29-Apr-2024","totalValueINR":"1371500","totalValueInUsd":"16423.7","indian_port":"Ahmedabad Air","hs_no":"29398000","bill_no":"3252078","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"CHENGDU","supplierAddress":"3 HUA NANYI ROAD, CHONGQING (CHANGSHOU) CHEMICAL INDUSTRY, CHONGQING,CHINA CHINA","customerAddress":"CLARIS CORPORATE HEAD QUARTERS,"}]
    23-Feb-2021
    07-Nov-2024
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    ABOUT THIS PAGE

    Looking for 107007-99-8 / Granisetron Hydrochloride API manufacturers, exporters & distributors?

    Granisetron Hydrochloride manufacturers, exporters & distributors 1

    15

    PharmaCompass offers a list of Granisetron Hydrochloride 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 Granisetron Hydrochloride manufacturer or Granisetron Hydrochloride supplier for your needs.

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

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

    API | Excipient name

    Granisetron Hydrochloride

    Synonyms

    Granisetron hcl, 107007-99-8, Granisetron (hydrochloride), Nsc-759839, 1-methyl-n-(9-methyl-9-azabicyclo[3.3.1]nonan-3-yl)indazole-3-carboxamide;hydrochloride, 1-methyl-1h-indazole-3-carboxylic acid (9-methyl-9-aza-bicyclo[3.3.1]non-3-yl)-amide hydrochloride

    Cas Number

    107007-99-8

    About Granisetron Hydrochloride

    A serotonin receptor (5HT-3 selective) antagonist that has been used as an antiemetic for cancer chemotherapy patients.

    GRANISTERON HYDROCHLORIDE Manufacturers

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

    GRANISTERON HYDROCHLORIDE Suppliers

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

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

    GRANISTERON HYDROCHLORIDE USDMF

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

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

    click here to find a list of GRANISTERON HYDROCHLORIDE suppliers with USDMF on PharmaCompass.

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

    GRANISTERON HYDROCHLORIDE KDMF

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

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

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

    click here to find a list of GRANISTERON HYDROCHLORIDE suppliers with KDMF on PharmaCompass.

    GRANISTERON HYDROCHLORIDE CEP

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

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

    GRANISTERON HYDROCHLORIDE WC

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

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

    GRANISTERON 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 GRANISTERON HYDROCHLORIDE as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of GRANISTERON HYDROCHLORIDE suppliers with NDC on PharmaCompass.

    GRANISTERON HYDROCHLORIDE GMP

    GRANISTERON 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 GRANISTERON 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 GRANISTERON HYDROCHLORIDE GMP manufacturer or GRANISTERON HYDROCHLORIDE GMP API supplier for your needs.

    GRANISTERON HYDROCHLORIDE CoA

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

    GRANISTERON HYDROCHLORIDE CoA mostly includes findings from lab analyses of a specific batch. For each GRANISTERON 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.

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