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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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SPIPA, SATELLITE ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1646850600,"product":"(FOC) - ATROPINE SULFATE - 3101600008","address":"NO.54\/1, BOODIHAL,,NELAMANGALA,","city":"BENGALURU,KARNATAKA","supplier":"ROLABO OUTSOURCING","supplierCountry":"SPAIN","foreign_port":"NA","customer":"SOMERSET THERAPEUTICS LIMITED","customerCountry":"INDIA","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"22000","totalValueFC":"66372.8","currency":"USD","unitRateINR":"1686300","date":"10-Mar-2022","totalValueINR":"5058900","totalValueInUsd":"66372.8","indian_port":"BANGALORE AIR","hs_no":"29397900","bill_no":"7809814","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"NO.54\/1, BOODIHAL,,NELAMANGALA,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1659033000,"product":"ATROPINE SULFATE API 164.77 GRAMS (FREE OF COST)(QTY: 3 BOTTLE)","address":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam","city":"Kelambakkam","supplier":"PAR PHARMACEUTICAL","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"0.16","actualQuantity":"0.16","unit":"KGS","unitRateFc":"18021.7","totalValueFC":"3107.4","currency":"USD","unitRateINR":"1544332.6","date":"29-Jul-2022","totalValueINR":"247093.21","totalValueInUsd":"3107.4","indian_port":"BOMBAY AIR","hs_no":"29397900","bill_no":"9776405","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1661279400,"product":"ATROPINE SULFATE USP (FOR TESTING PURPOSE)","address":"212 ASHIRWAD COMMERCIAL COMPLEX,D- 1 GREEN PARK,","city":"NEW DELHI,DELHI","supplier":"ROLABO OUTSOURCING","supplierCountry":"SPAIN","foreign_port":"NA","customer":"SENTISS PHARMA","customerCountry":"INDIA","quantity":"0.20","actualQuantity":"200","unit":"GMS","unitRateFc":"24.5","totalValueFC":"5083.7","currency":"EUR","unitRateINR":"2022.5","date":"24-Aug-2022","totalValueINR":"404495","totalValueInUsd":"5083.7","indian_port":"DELHI AIR","hs_no":"29420090","bill_no":"2145048","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"212 ASHIRWAD COMMERCIAL COMPLEX,D- 1 GREEN PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1666204200,"product":"ATROPINE SULFATE (100 GMS)","address":"901-911 9TH FLR ISCON ELEGANCE NR SHAPATH 5 S G HIGHWAY Contact No: 9","city":"AHMEDABAD","supplier":"HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO., LTD","supplierCountry":"CHINA","foreign_port":"NA","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"21000","totalValueFC":"2705.4","currency":"USD","unitRateINR":"2226150","date":"20-Oct-2022","totalValueINR":"222615","totalValueInUsd":"2705.4","indian_port":"AHMEDABAD AIR","hs_no":"29339990","bill_no":"2959598","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"901-911 9TH FLR ISCON ELEGANCE NR SHAPATH 5 S G HIGHWAY Contact No: 9"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1675535400,"product":"ATROPINE SULFATE","address":"SHANKAR TOWERS PLOT NO. A30,A.I.E BALANAGAR HYDERABAD","city":"HYDERABAD,TELANGANA","supplier":"M\/S C-SQUARED PHARMA LTD","supplierCountry":"IRELAND","foreign_port":"NA","customer":"ANTHEA PHARMA PVT LTD","customerCountry":"INDIA","quantity":"0.06","actualQuantity":"0.06","unit":"KGS","unitRateFc":"16500","totalValueFC":"1693.3","currency":"USD","unitRateINR":"2330791.7","date":"05-Feb-2023","totalValueINR":"139847.5","totalValueInUsd":"1693.3","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"4505405","productDescription":"API","marketType":"REGULATED MARKET","country":"IRELAND","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SHANKAR TOWERS PLOT NO. A30,A.I.E BALANAGAR HYDERABAD"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1694543400,"product":"ATROPINE SULFATE","address":"NO.27,RACE COURSE ROAD,","city":"KARNATAKA","supplier":"C-SQUARED PHARMA","supplierCountry":"INDIA","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MICRO LABS LIMITED","customerCountry":"INDIA","quantity":"0.03","actualQuantity":"0.03","unit":"KGS","unitRateFc":"100","totalValueFC":"660.4","currency":"USD","unitRateINR":"1827311.7","date":"13-Sep-2023","totalValueINR":"54819.35","totalValueInUsd":"660.4","indian_port":"Madras Air","hs_no":"29397900","bill_no":"7814242","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"BRIDGE HOUSE UNIT 2SKEHARD ROAD,T12 H2TK CORK, IRELAND","customerAddress":"NO.27,RACE COURSE ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1709317800,"product":"ATROPINE SULPHATE","address":"208, OKHLA INDUSTRIAL ESTATE,,PHAS","city":"NEW DELHI,DELHI","supplier":"C-SQUARED PHARMA","supplierCountry":"INDIA","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MANKIND PHARMA","customerCountry":"INDIA","quantity":"2.64","actualQuantity":"2.64","unit":"KGS","unitRateFc":"14500","totalValueFC":"39145.2","currency":"USD","unitRateINR":"1231232.5","date":"02-Mar-2024","totalValueINR":"3250453.8","totalValueInUsd":"39145.2","indian_port":"Delhi Air","hs_no":"29398000","bill_no":"2401589","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"BRIDGE HOUSE UNIT 2 SKEHARD ROADT12 H2TK CORK IRELAND. SDNF","customerAddress":"208, OKHLA INDUSTRIAL ESTATE,,PHAS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1709317800,"product":"ATROPINE SULPHATE","address":"208, OKHLA INDUSTRIAL ESTATE,,PHAS","city":"NEW DELHI,DELHI","supplier":"C-SQUARED PHARMA","supplierCountry":"INDIA","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MANKIND PHARMA","customerCountry":"INDIA","quantity":"3.08","actualQuantity":"3.08","unit":"KGS","unitRateFc":"14500","totalValueFC":"45669.4","currency":"USD","unitRateINR":"1231232.5","date":"02-Mar-2024","totalValueINR":"3792196.1","totalValueInUsd":"45669.4","indian_port":"Delhi Air","hs_no":"29398000","bill_no":"2401589","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"BRIDGE HOUSE UNIT 2 SKEHARD ROADT12 H2TK CORK IRELAND. SDNF","customerAddress":"208, OKHLA INDUSTRIAL ESTATE,,PHAS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718044200,"product":"(FOC) - ATROPINE SULFATE - LL\/15\/25098 - A013230723","address":"REGD. OFFICE: NO. 16\/2,","city":"BANGALORE, KARNATAKA","supplier":"C-SQUARED PHARMA","supplierCountry":"IRELAND","foreign_port":"DUBLIN","customer":"SOMERSET THERAPEUTICS LIMITED","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"22000","totalValueFC":"112798","currency":"USD","unitRateINR":"1883262","date":"11-Jun-2024","totalValueINR":"9416310","totalValueInUsd":"112798","indian_port":"Bangalore Air","hs_no":"29397900","bill_no":"3941632","productDescription":"API","marketType":"REGULATED MARKET","country":"IRELAND","selfForZScoreResived":"Pharma Grade","supplierPort":"DUBLIN","supplierAddress":"BRIDGE HOUSE UNIT 2 SHEHARD ROAD T12 H2TK CORK IRELAND (IRL) Dublin, ,Ireland Ireland","customerAddress":"REGD. OFFICE: NO. 16\/2,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719513000,"product":"31016 ATROPINE SULFATE( TEST LICENCE SW\/OD\/11\/2024\/000001588 DATE 08.05.2024 ) ( R & D PURPOSE )","address":"208, OKHLA INDUSTRIAL ESTATE,,PHAS","city":"NEW DELHI,DELHI","supplier":"ROLABO OUTSOURCING","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"MANKIND PHARMA","customerCountry":"INDIA","quantity":"0.75","actualQuantity":"0.75","unit":"KGS","unitRateFc":"11760","totalValueFC":"8906.7","currency":"USD","unitRateINR":"991368","date":"28-Jun-2024","totalValueINR":"743526","totalValueInUsd":"8906.7","indian_port":"Delhi Air","hs_no":"29398000","bill_no":"4227136","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"POL. IND. MALPICA CALLE J. 3-450016 ZARAGOZA ESPANA. SDNF","customerAddress":"208, OKHLA INDUSTRIAL ESTATE,,PHAS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720549800,"product":"ATROPINE SULFATE","address":"SHANKAR TOWERS PLOT NO. A30,A.I.E","city":"HYDERABAD,TELANGANA","supplier":"C SQUARED PHARMA LTD.","supplierCountry":"IRELAND","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"ANTHEA PHARMA PVT LTD","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"16500","totalValueFC":"9143","currency":"USD","unitRateINR":"1528545","date":"10-Jul-2024","totalValueINR":"764272.5","totalValueInUsd":"9143","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"4427703","productDescription":"API","marketType":"REGULATED MARKET","country":"IRELAND","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"BRIDGE HOUSE UNIT 2,SKEHARD ROAD,T12 H2TK CORK, IRELAND","customerAddress":"SHANKAR TOWERS PLOT NO. A30,A.I.E"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721845800,"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":"FRANKFURT\/MAIN INT\\'L","customer":"MANKIND PHARMA","customerCountry":"INDIA","quantity":"5.50","actualQuantity":"5.5","unit":"KGS","unitRateFc":"14500","totalValueFC":"89584","currency":"EUR","unitRateINR":"1361531.3","date":"25-Jul-2024","totalValueINR":"7488421.88","totalValueInUsd":"89584","indian_port":"Delhi Air","hs_no":"29398000","bill_no":"4688106","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"BRIDGE HOUSE UNIT 2, SKEHARD ROAD,T12 H2TK CORK,SDNF IRELAND","customerAddress":"208, OKHLA INDUSTRIAL ESTATE,,PHAS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725561000,"product":"ATROPINE SULFATE(SB NO.9366473\/31.03.2022)","address":"2ND FLOOR, SERENE CHAMBERS,,ROAD N","city":"HYDEABAD,TELANGANA","supplier":"C-SQUARED PHARMA LIMITED.","supplierCountry":"INDIA","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"LAURUS LABS","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"1220","totalValueFC":"1236","currency":"USD","unitRateINR":"103578","date":"06-Sep-2024","totalValueINR":"103578","totalValueInUsd":"1236","indian_port":"Madras Air","hs_no":"29339990","bill_no":"5469300","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"BRIDGE HOUSE UNIT-2 SKEHARD ROAD T12 H2TK CORK(IRL) IE IE","customerAddress":"2ND FLOOR, SERENE CHAMBERS,,ROAD N"},{"dataSource":"API 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":"0.60","actualQuantity":"0.6","unit":"KGS","unitRateFc":"14500","totalValueFC":"9748.4","currency":"EUR","unitRateINR":"1365203.1","date":"28-Oct-2024","totalValueINR":"819121.88","totalValueInUsd":"9748.4","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":"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":"0.67","actualQuantity":"0.67","unit":"KGS","unitRateFc":"14500","totalValueFC":"10885.7","currency":"EUR","unitRateINR":"1365203.1","date":"28-Oct-2024","totalValueINR":"914686.09","totalValueInUsd":"10885.7","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"}]
    08-Jan-2021
    28-Oct-2024
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    DRUG PRODUCT COMPOSITIONS

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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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    USP

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    ABOUT THIS PAGE

    Atropine Sulfate Manufacturers

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

    Atropine Sulfate Suppliers

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

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

    Atropine Sulfate USDMF

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

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

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

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

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

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

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

    Atropine Sulfate CEP

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

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

    Atropine Sulfate WC

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

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

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

    Finished drug products

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

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

    Atropine Sulfate GMP

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

    Atropine Sulfate CoA

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

    Atropine Sulfate CoA mostly includes findings from lab analyses of a specific batch. For each Atropine Sulfate 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 Sulfate may be tested according to a variety of international standards, such as European Pharmacopoeia (Atropine Sulfate EP), Atropine Sulfate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Atropine Sulfate 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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