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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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    27-Jan-2021
    21-Feb-2025
    KGS
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    Looking for / Sulfasalazine API manufacturers, exporters & distributors?

    Sulfasalazine manufacturers, exporters & distributors 1

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    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

    Sulcolon Manufacturers

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

    Sulcolon Suppliers

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

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

    Sulcolon USDMF

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

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

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

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

    Sulcolon KDMF

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

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

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

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

    Sulcolon CEP

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

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

    Sulcolon WC

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

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

    Sulcolon 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 Sulcolon as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Sulcolon GMP

    Sulcolon 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 Sulcolon 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 Sulcolon GMP manufacturer or Sulcolon GMP API supplier for your needs.

    Sulcolon CoA

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

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

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