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    Chemistry

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    Also known as: Schembl34274, Ft-0603494, Ft-0656045
    Molecular Formula
    C34H48N2O10S
    Molecular Weight
    676.8  g/mol
    InChI Key
    HOBWAPHTEJGALG-UHFFFAOYSA-N
    Atropine Sulfate
    1 2D Structure

    Atropine Sulfate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (8-methyl-8-azoniabicyclo[3.2.1]octan-3-yl) 3-hydroxy-2-phenylpropanoate;sulfate
    2.1.2 InChI
    InChI=1S/2C17H23NO3.H2O4S/c2*1-18-13-7-8-14(18)10-15(9-13)21-17(20)16(11-19)12-5-3-2-4-6-12;1-5(2,3)4/h2*2-6,13-16,19H,7-11H2,1H3;(H2,1,2,3,4)
    2.1.3 InChI Key
    HOBWAPHTEJGALG-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C[NH+]1C2CCC1CC(C2)OC(=O)C(CO)C3=CC=CC=C3.C[NH+]1C2CCC1CC(C2)OC(=O)C(CO)C3=CC=CC=C3.[O-]S(=O)(=O)[O-]
    2.2 Synonyms
    2.2.1 Depositor-Supplied Synonyms

    1. Schembl34274

    2. Ft-0603494

    3. Ft-0656045

    2.3 Create Date
    2012-08-08
    3 Chemical and Physical Properties
    Molecular Weight 676.8 g/mol
    Molecular Formula C34H48N2O10S
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count10
    Rotatable Bond Count10
    Exact Mass676.30296691 g/mol
    Monoisotopic Mass676.30296691 g/mol
    Topological Polar Surface Area191 Ų
    Heavy Atom Count47
    Formal Charge0
    Complexity415
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count6
    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 NameAtropine sulfate
    Drug LabelAtropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by subcutaneous, intr...
    Active IngredientAtropine sulfate
    Dosage FormSolution/drops
    RouteOphthalmic
    Strength1%
    Market StatusPrescription
    CompanyAkorn

    2 of 2  
    Drug NameAtropine sulfate
    Drug LabelAtropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by subcutaneous, intr...
    Active IngredientAtropine sulfate
    Dosage FormSolution/drops
    RouteOphthalmic
    Strength1%
    Market StatusPrescription
    CompanyAkorn

    API Reference Price

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Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730053800,"product":"LL\/15\/25098 ATROPINE SULFATE (ATROPINE SULPHATE)","address":"208, OKHLA INDUSTRIAL ESTATE,,PHAS","city":"NEW DELHI,DELHI","supplier":"C-SQUARED PHARMA","supplierCountry":"INDIA","foreign_port":"MUNICH","customer":"MANKIND PHARMA","customerCountry":"INDIA","quantity":"2.04","actualQuantity":"2.042","unit":"KGS","unitRateFc":"14500","totalValueFC":"33177","currency":"EUR","unitRateINR":"1365203.1","date":"28-Oct-2024","totalValueINR":"2787744.78","totalValueInUsd":"33177","indian_port":"Delhi Air","hs_no":"29398000","bill_no":"6377228","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"MUNICH","supplierAddress":"BRIDGE HOUSE UNIT 2, SKEHARD ROAD, T12 H2TK CORK, SDNF IRELAND","customerAddress":"208, OKHLA INDUSTRIAL ESTATE,,PHAS"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1739817000,"product":"31016 ATROPINE SULFATE API (IMP LIC.NO.SW\/OD\/11\/2024\/000006614)31016 ATROPINE SULFATE (IMP LIC.NO.SW\/OD\/11\/2024\/000006614)","address":"208, OKHLA INDUSTRIAL ESTATE,,PHAS","city":"NEW DELHI,DELHI","supplier":"ROLABO OUTSOURCING","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"MANKIND PHARMA","customerCountry":"INDIA","quantity":"3.32","actualQuantity":"3.32","unit":"KGS","unitRateFc":"11760","totalValueFC":"39687.9","currency":"USD","unitRateINR":"1039584","date":"18-Feb-2025","totalValueINR":"3451418.88","totalValueInUsd":"39687.9","indian_port":"Delhi Air","hs_no":"29397900","bill_no":"8423352","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"POL. IND. MALPICA, CALLE J 3-4 - 50016 ZARAGOZA ESPANA SPAIN","customerAddress":"208, OKHLA INDUSTRIAL ESTATE,,PHAS"}]
    15-Jan-2021
    13-Mar-2025
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    DOSAGE - TABLET;ORAL - 0.025MG;2.5MG

    USFDA APPLICATION NUMBER - 12462

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    DOSAGE - INJECTABLE;INJECTION - 0.14MG/ML;10M...DOSAGE - INJECTABLE;INJECTION - 0.14MG/ML;10MG/ML

    USFDA APPLICATION NUMBER - 19678

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    DOSAGE - SOLUTION;INTRAVENOUS - 0.25MG/5ML (0...DOSAGE - SOLUTION;INTRAVENOUS - 0.25MG/5ML (0.05MG/ML)

    USFDA APPLICATION NUMBER - 21146

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    DOSAGE - SOLUTION;INTRAVENOUS - 0.5MG/5ML (0....DOSAGE - SOLUTION;INTRAVENOUS - 0.5MG/5ML (0.1MG/ML)

    USFDA APPLICATION NUMBER - 21146

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    DOSAGE - SOLUTION;INTRAVENOUS - 1MG/10ML (0.1...DOSAGE - SOLUTION;INTRAVENOUS - 1MG/10ML (0.1MG/ML)

    USFDA APPLICATION NUMBER - 21146

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    ABOUT THIS PAGE

    Looking for / Atropine Sulfate API manufacturers, exporters & distributors?

    Atropine Sulfate manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Atropine Sulfate

    Synonyms

    Schembl34274, Ft-0603494, Ft-0656045

    AtroPen Manufacturers

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

    AtroPen Suppliers

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

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

    AtroPen USDMF

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

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

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

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

    AtroPen KDMF

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

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

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

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

    AtroPen CEP

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

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

    AtroPen WC

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

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

    AtroPen 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 AtroPen as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    AtroPen GMP

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

    AtroPen CoA

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

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

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