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    Chemistry

    Click the arrow to open the dropdown
    read-moreClick the button for full data set
    read-moreClick the button for full data set
    Also known as:
    Molecular Formula
    C18H14N4O5S
    Molecular Weight
    398.4  g/mol
    InChI Key
    OQANPHBRHBJGNZ-BKUYFWCQSA-N
    Sulfasalazine
    1 2D Structure

    Sulfasalazine

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (3Z)-6-oxo-3-[[4-(pyridin-2-ylsulfamoyl)phenyl]hydrazinylidene]cyclohexa-1,4-diene-1-carboxylic acid
    2.1.2 InChI
    InChI=1S/C18H14N4O5S/c23-16-9-6-13(11-15(16)18(24)25)21-20-12-4-7-14(8-5-12)28(26,27)22-17-3-1-2-10-19-17/h1-11,20H,(H,19,22)(H,24,25)/b21-13-
    2.1.3 InChI Key
    OQANPHBRHBJGNZ-BKUYFWCQSA-N
    2.1.4 Canonical SMILES
    C1=CC=NC(=C1)NS(=O)(=O)C2=CC=C(C=C2)NN=C3C=CC(=O)C(=C3)C(=O)O
    2.1.5 Isomeric SMILES
    C1=CC=NC(=C1)NS(=O)(=O)C2=CC=C(C=C2)N/N=C\3/C=CC(=O)C(=C3)C(=O)O
    2.2 Create Date
    2005-03-26
    3 Chemical and Physical Properties
    Molecular Weight 398.4 g/mol
    Molecular Formula C18H14N4O5S
    XLogP32.3
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count9
    Rotatable Bond Count6
    Exact Mass398.06849073 g/mol
    Monoisotopic Mass398.06849073 g/mol
    Topological Polar Surface Area146 A^2
    Heavy Atom Count28
    Formal Charge0
    Complexity804
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 6  
    Drug NameAzulfidine
    PubMed HealthSalicylate (Oral route, Rectal route)
    Drug ClassesAntirheumatic, Gastrointestinal Agent
    Drug LabelAZULFIDINE EN-tabs Tablets contain sulfasalazine, formulated in a delayed release tablet (enteric-coated), 500 mg, for oral administration.AZULFIDINE EN-tabs Tablets are film coated with cellulose acetate phthalate to retard disintegration of the tab...
    Active IngredientSulfasalazine
    Dosage FormTablet; Suspension
    RouteOral
    Strength500mg; 250mg/5ml
    Market StatusPrescription
    CompanyPharmacia And Upjohn

    2 of 6  
    Drug NameAzulfidine en-tabs
    PubMed HealthSulfasalazine (By mouth)
    Drug LabelAZULFIDINE EN-tabs Tablets contain sulfasalazine, formulated in a delayed release tablet (enteric-coated), 500 mg, for oral administration.AZULFIDINE EN-tabs Tablets are film coated with cellulose acetate phthalate to retard disintegration of the tab...
    Active IngredientSulfasalazine
    Dosage FormTablet; Tablet, delayed release
    Routeoral; Oral
    Strength500mg
    Market StatusPrescription
    CompanyPharmacia Upjohn; Pharmacia And Upjohn

    3 of 6  
    Drug NameSulfasalazine
    Drug LabelSulfasalazine Tablets USP, 500 mg for Oral AdministrationTherapeutic classification: Anti-inflammatory agent.Chemical designation: 5-[[p-(2-Pyridylsulfamoyl)phenyl]azo]salicylic acid.Chemical Structure:The molecular weight of sulfasalazine is 398.39....
    Active IngredientSulfasalazine
    Dosage FormTablet; Tablet, delayed release
    RouteOral
    Strength500mg
    Market StatusPrescription
    CompanyVintage Pharms; Watson Labs

    4 of 6  
    Drug NameAzulfidine
    PubMed HealthSalicylate (Oral route, Rectal route)
    Drug ClassesAntirheumatic, Gastrointestinal Agent
    Drug LabelAZULFIDINE EN-tabs Tablets contain sulfasalazine, formulated in a delayed release tablet (enteric-coated), 500 mg, for oral administration.AZULFIDINE EN-tabs Tablets are film coated with cellulose acetate phthalate to retard disintegration of the tab...
    Active IngredientSulfasalazine
    Dosage FormTablet; Suspension
    RouteOral
    Strength500mg; 250mg/5ml
    Market StatusPrescription
    CompanyPharmacia And Upjohn

    5 of 6  
    Drug NameAzulfidine en-tabs
    PubMed HealthSulfasalazine (By mouth)
    Drug LabelAZULFIDINE EN-tabs Tablets contain sulfasalazine, formulated in a delayed release tablet (enteric-coated), 500 mg, for oral administration.AZULFIDINE EN-tabs Tablets are film coated with cellulose acetate phthalate to retard disintegration of the tab...
    Active IngredientSulfasalazine
    Dosage FormTablet; Tablet, delayed release
    Routeoral; Oral
    Strength500mg
    Market StatusPrescription
    CompanyPharmacia Upjohn; Pharmacia And Upjohn

    6 of 6  
    Drug NameSulfasalazine
    Drug LabelSulfasalazine Tablets USP, 500 mg for Oral AdministrationTherapeutic classification: Anti-inflammatory agent.Chemical designation: 5-[[p-(2-Pyridylsulfamoyl)phenyl]azo]salicylic acid.Chemical Structure:The molecular weight of sulfasalazine is 398.39....
    Active IngredientSulfasalazine
    Dosage FormTablet; Tablet, delayed release
    RouteOral
    Strength500mg
    Market StatusPrescription
    CompanyVintage Pharms; Watson Labs

    API Reference Price

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INDL ESTATE","city":"HYDERABAD.AP","supplier":"VIRCHOW DRUGS LIMITED","supplierCountry":"INDIA","foreign_port":"VERACRUZ","customer":"HELM DE MEXICO SA","customerCountry":"MEXICO","quantity":"5000.00","actualQuantity":"5000","unit":"KGS","unitRateFc":"25.5","totalValueFC":"122560","currency":"USD","unitRateINR":2113.6500000000001,"date":"23-Jan-2025","totalValueINR":"10568250","totalValueInUsd":"122560","indian_port":"Hyderabad ICD","hs_no":"29359090","bill_no":"7526336","productDescription":"API","marketType":"","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad ICD","supplierAddress":"PLOT NO.9, S.V.CO-OP. INDL ESTATE, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738175400,"product":"SULFASALAZINE USP","address":"PLOT NO.9, S.V.CO-OP. INDL ESTATE","city":"HYDERABAD.AP","supplier":"VIRCHOW DRUGS LIMITED","supplierCountry":"INDIA","foreign_port":"DUBAI","customer":"SUN GOAL TRADING LLC","customerCountry":"UNITED ARAB EMIRATES","quantity":"7000.00","actualQuantity":"7000","unit":"KGS","unitRateFc":"25","totalValueFC":"174710.2","currency":"EURO","unitRateINR":2152.1599657142856,"date":"30-Jan-2025","totalValueINR":"15065119.76","totalValueInUsd":"174710.2","indian_port":"Hyderabad ICD","hs_no":"29359090","bill_no":"7741903","productDescription":"API","marketType":"","country":"UNITED ARAB EMIRATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad ICD","supplierAddress":"PLOT NO.9, S.V.CO-OP. INDL ESTATE, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1739903400,"product":"SULFASALAZINE USP","address":"NO.202, SVS CLASSIC RESIDENCY","city":"HYDERABAD, AP","supplier":"VALENS MOLECULES PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"BUSAN(KOREA)","customer":"TO THE ORDER","customerCountry":"KOREA, REPUBLIC OF","quantity":"4500.00","actualQuantity":"4500","unit":"KGS","unitRateFc":"59","totalValueFC":"260925.2","currency":"USD","unitRateINR":5042.4719999999998,"date":"19-Feb-2025","totalValueINR":"22691124","totalValueInUsd":"260925.2","indian_port":"JNPT","hs_no":"29359090","bill_no":"8319328","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"NO.202, SVS CLASSIC RESIDENCY, HYDERABAD, AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740076200,"product":"HSN CODE DESCRIPTION ARN NO: AD3603240219719 PRODUCT DESCRIPTION SULFASALAZINE USP.","address":"H N.8-2-269\/W\/4,1ST FLOOR,PLOT NO.","city":"BANJARA HILLS HYDERABAD,TELANGANA","supplier":"HRV GLOBAL LIFE SCIENCES PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"JEBEL ALI","customer":"UNDISCLOSED","customerCountry":"UNITED ARAB EMIRATES","quantity":"5000.00","actualQuantity":"5000","unit":"KGS","unitRateFc":"120.6","totalValueFC":"156678.6","currency":"AED","unitRateINR":2725.0830000000001,"date":"21-Feb-2025","totalValueINR":"13625415","totalValueInUsd":"156678.6","indian_port":"JNPT","hs_no":"29359090","bill_no":"8382213","productDescription":"API","marketType":"","country":"UNITED ARAB EMIRATES","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"H N.8-2-269\/W\/4,1ST FLOOR,PLOT NO., BANJARA HILLS HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741285800,"product":"SULFASALAZINE USP","address":"BHAGWAN BHUVAN","city":"MUMBAI ,MAHARASHTRA","supplier":"KUTTAMLAL (EXPORTS) PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. K","customer":"AMPAK COMPANY INC","customerCountry":"UNITED STATES","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"73.5","totalValueFC":"1815","currency":"USD","unitRateINR":6288.3156000000008,"date":"07-Mar-2025","totalValueINR":"157207.89","totalValueInUsd":"1815","indian_port":"Hyderabad Air","hs_no":"29359090","bill_no":"8814397","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"BHAGWAN BHUVAN, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742322600,"product":"SULFASALAZINE EP","address":"PLOT NO.9, S.V.CO-OP. INDL ESTATE","city":"HYDERABAD.AP","supplier":"VIRCHOW DRUGS LIMITED","supplierCountry":"INDIA","foreign_port":"HAMBURG","customer":"BMP BULK MEDICINES &","customerCountry":"GERMANY","quantity":"425.00","actualQuantity":"425","unit":"KGS","unitRateFc":"35","totalValueFC":"14773.7","currency":"USD","unitRateINR":3010.9676470588233,"date":"19-Mar-2025","totalValueINR":"1279661.25","totalValueInUsd":"14773.7","indian_port":"Hyderabad ICD","hs_no":"29359090","bill_no":"9148339","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad ICD","supplierAddress":"PLOT NO.9, S.V.CO-OP. INDL ESTATE, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1666722600,"product":"SULFASALAZINE EP","address":"781, INDUSTRIAL AREA,,PHASE-II,","city":"CHANDIGARH,CHANDIGARH","supplier":"PREMIER STAR PHARMA LIMITED","supplierCountry":"CHINA","foreign_port":"NA","customer":"IND SWIFT LIMITED","customerCountry":"INDIA","quantity":"300.00","actualQuantity":"300","unit":"KGS","unitRateFc":"69","totalValueFC":"21106.5","currency":"USD","unitRateINR":"5789.1","date":"26-Oct-2022","totalValueINR":"1736730","totalValueInUsd":"21106.5","indian_port":"DELHI AIR","hs_no":"29359090","bill_no":"3033481","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"781, INDUSTRIAL AREA,,PHASE-II,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1675967400,"product":"SULFASALAZINE PH.EUR (CEP GRADE) (GOODS ARE FOR TESTING, ANALYSIS AND DEVELOPMENT PURPOSE ONLY AND NOT FOR COMMERCIAL US","address":"OFFICENO 5-6COMMERCE AVENUE PAUD R D,S NO 127 MAHAGANESH COL KOTHRUD","city":"PUNE,MAHARASHTRA","supplier":"JIANGSU RUIKE PHARMACEUTICAL SCI-TECH COLTD","supplierCountry":"CHINA","foreign_port":"NA","customer":"BATAVIA PHARMA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"120","totalValueFC":"3005.8","currency":"USD","unitRateINR":"9930","date":"10-Feb-2023","totalValueINR":"248250","totalValueInUsd":"3005.8","indian_port":"BOMBAY AIR","hs_no":"29359090","bill_no":"4582885","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"OFFICENO 5-6COMMERCE AVENUE PAUD R D,S NO 127 MAHAGANESH COL KOTHRUD"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1677695400,"product":"SULFASALAZINE EP","address":"781, INDUSTRIAL AREA,,PHASE-II,","city":"CHANDIGARH,CHANDIGARH","supplier":"PREMIER STAR PHARMA LIMITED","supplierCountry":"CHINA","foreign_port":"NA","customer":"IND SWIFT LIMITED","customerCountry":"INDIA","quantity":"2200.00","actualQuantity":"2200","unit":"KGS","unitRateFc":"69","totalValueFC":"154383.1","currency":"USD","unitRateINR":"5771.9","date":"02-Mar-2023","totalValueINR":"12698070","totalValueInUsd":"154383.1","indian_port":"DELHI AIR","hs_no":"29359090","bill_no":"4863050","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"781, INDUSTRIAL AREA,,PHASE-II,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1692642600,"product":"SULFASALAZINE,BATCH NO.200900A2305034 AS PER DOCUMENT","address":"B-103, HARASIDDH APPARTMENTS, ,NR. MANDAKINI TENAMENTS, NR. K.K. ,NAGAR GHATLODIA","city":"AHMEDABAD","supplier":"ZHEJIANG JIUZHOU PHARMACETICAL CO L","supplierCountry":"CHINA","foreign_port":"NA","customer":"ORBIT PHARMACEUTICALS","customerCountry":"INDIA","quantity":"110.00","actualQuantity":"110","unit":"KGS","unitRateFc":"85","totalValueFC":"9451.1","currency":"USD","unitRateINR":"7046.1","date":"22-Aug-2023","totalValueINR":"782896.07","totalValueInUsd":"9451.1","indian_port":"AHEMDABAD AIR","hs_no":"29420090","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B-103, HARASIDDH APPARTMENTS, ,NR. MANDAKINI TENAMENTS, NR. K.K. ,NAGAR GHATLODIA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1714933800,"product":"SULFASALAZINE U.S.P.","address":"PLOT NO. 221, G.I.D.C.,","city":"GUJARAT","supplier":"ADVENTAPHARMA DWC-LLC","supplierCountry":"UNITED STATES","foreign_port":"CHICAGO O\\'HARE INT\\'L","customer":"UMEDICA LABORATORIES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"300.00","actualQuantity":"300","unit":"KGS","unitRateFc":"225","totalValueFC":"68306.4","currency":"USD","unitRateINR":"18978.8","date":"06-May-2024","totalValueINR":"5693625","totalValueInUsd":"68306.4","indian_port":"Bombay Air","hs_no":"29359090","bill_no":"3358457","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"CHICAGO O\\'HARE INT\\'L","supplierAddress":"1802 TRIDENT BAYSIDE DUBAI MARINA,DUBAI U.A.E. P.O.BOX 390667SDNF United Arab Emirates","customerAddress":"PLOT NO. 221, G.I.D.C.,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723228200,"product":"SULFASALAZINE ( LICENCE TO IMPORT NEW DRUG PURPOSE OF CLINICAL TRIAL )","address":"ASTER FLAT NO 402 REGENCY GARDENS,","city":"KHARGHAR,MAHARASHTRA","supplier":"ZHEJIANG JIOZHOU PHARMACEUTICALCO","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"PROSFORA TECHNOLOGIES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"125.00","actualQuantity":"125","unit":"KGS","unitRateFc":"120","totalValueFC":"15129","currency":"USD","unitRateINR":"10152","date":"10-Aug-2024","totalValueINR":"1269000","totalValueInUsd":"15129","indian_port":"Bombay Air","hs_no":"29359090","bill_no":"4986176","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"LTD WELDING GMBH AND CO.KG HAMBURGWAISHA ROAD 99, JIAOJIANG TAIZHOUCITY ZHEJIANG 318000 CHINA","customerAddress":"ASTER FLAT NO 402 REGENCY GARDENS,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732645800,"product":"SULFASALAZINE (GOODS ARE FOR TESTING, ANALYSIS AND DEVELOPMENT PURPOSE ONLY AND NOT FOR COMMERCIAL USE)","address":"OFFICENO 5-6COMMERCE AVENUE PAUD R","city":"PUNE,MAHARASHTRA","supplier":"BIOBETTA LIMITED","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"BATAVIA PHARMA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"120","totalValueFC":"3034.2","currency":"USD","unitRateINR":"10242","date":"27-Nov-2024","totalValueINR":"256050","totalValueInUsd":"3034.2","indian_port":"Bombay Air","hs_no":"29359090","bill_no":"6911722","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"SUITE 506-507,BUILDING 35, HH PARK, NO.2777 EAST JINXIU ROAD, PUDONG N EW AREA,SHANGHAI 201206,CHINA CHINA","customerAddress":"OFFICENO 5-6COMMERCE AVENUE PAUD R"}]
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    19-Mar-2025
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    ABOUT THIS PAGE

    Looking for / Sulfasalazine API manufacturers, exporters & distributors?

    Sulfasalazine manufacturers, exporters & distributors 1

    81

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

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

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

    API | Excipient name

    Sulfasalazine

    Azulfidine;Salazopyrin;Sulphasalazine Manufacturers

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

    Azulfidine;Salazopyrin;Sulphasalazine Suppliers

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

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

    Azulfidine;Salazopyrin;Sulphasalazine USDMF

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

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

    click here to find a list of Azulfidine;Salazopyrin;Sulphasalazine suppliers with USDMF on PharmaCompass.

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

    Azulfidine;Salazopyrin;Sulphasalazine KDMF

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

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

    After submitting a Azulfidine;Salazopyrin;Sulphasalazine 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 Azulfidine;Salazopyrin;Sulphasalazine API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Azulfidine;Salazopyrin;Sulphasalazine suppliers with KDMF on PharmaCompass.

    Azulfidine;Salazopyrin;Sulphasalazine CEP

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

    A Azulfidine;Salazopyrin;Sulphasalazine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Azulfidine;Salazopyrin;Sulphasalazine 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 Azulfidine;Salazopyrin;Sulphasalazine suppliers with CEP (COS) on PharmaCompass.

    Azulfidine;Salazopyrin;Sulphasalazine WC

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

    click here to find a list of Azulfidine;Salazopyrin;Sulphasalazine suppliers with Written Confirmation (WC) on PharmaCompass.

    Azulfidine;Salazopyrin;Sulphasalazine 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 Azulfidine;Salazopyrin;Sulphasalazine as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Azulfidine;Salazopyrin;Sulphasalazine suppliers with NDC on PharmaCompass.

    Azulfidine;Salazopyrin;Sulphasalazine GMP

    Azulfidine;Salazopyrin;Sulphasalazine 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 Azulfidine;Salazopyrin;Sulphasalazine 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 Azulfidine;Salazopyrin;Sulphasalazine GMP manufacturer or Azulfidine;Salazopyrin;Sulphasalazine GMP API supplier for your needs.

    Azulfidine;Salazopyrin;Sulphasalazine CoA

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

    Azulfidine;Salazopyrin;Sulphasalazine CoA mostly includes findings from lab analyses of a specific batch. For each Azulfidine;Salazopyrin;Sulphasalazine 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.

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