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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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    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

    Atropine Sulphate Manufacturers

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

    Atropine Sulphate Suppliers

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

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

    Atropine Sulphate USDMF

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

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

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

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

    Atropine Sulphate KDMF

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

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

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

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

    Atropine Sulphate CEP

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

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

    Atropine Sulphate WC

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

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

    Atropine Sulphate 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 Atropine Sulphate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Atropine Sulphate GMP

    Atropine Sulphate 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 Atropine Sulphate 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 Atropine Sulphate GMP manufacturer or Atropine Sulphate GMP API supplier for your needs.

    Atropine Sulphate CoA

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

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

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