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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 SUPPLIERS

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USDMF

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GDUFA

DMF Review : N/A

Rev. Date :

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DMF Number : 31278

Submission : 2016-12-20

Status : Active

Type : II

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DMF Review : Complete

Rev. Date : 2019-09-25

Pay. Date : 2019-06-25

DMF Number : 33781

Submission : 2019-08-08

Status : Active

Type : II

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DMF Review : N/A

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DMF Number : 5494

Submission : 1984-01-11

Status : Inactive

Type : II

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C-squared Pharma Ltd

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DMF Review : Complete

Rev. Date : 2017-01-23

Pay. Date : 2016-11-18

DMF Number : 30605

Submission : 2016-09-09

Status : Active

Type : II

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Kv Pharmaceutical Co

Switzerland

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Kv Pharmaceutical Co

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Submission : 1982-11-01

Status : Inactive

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DMF Review : Complete

Rev. Date : 2015-12-18

Pay. Date : 2015-08-31

DMF Number : 28978

Submission : 2014-12-25

Status : Active

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Rev. Date : 2016-10-07

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DMF Number : 30227

Submission : 2016-01-21

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DMF Number : 29803

Submission : 2015-09-24

Status : Active

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DMF Review : Complete

Rev. Date : 2015-11-06

Pay. Date : 2015-05-22

DMF Number : 29396

Submission : 2015-05-25

Status : Active

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CEP/COS

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R1-CEP 2015-373 - Rev 00
Valid
Chemical
2023-01-11
68
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Certificate Number : R1-CEP 2015-373 - Rev 00

Status : Valid

Issue Date : 2023-01-11

Type : Chemical

Substance Number : 68

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Certificate Number : R1-CEP 2000-299 - Rev 02

Status : Withdrawn by Holder

Issue Date : 2011-02-18

Type : Chemical

Substance Number : 68

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Certificate Number : CEP 2016-216 - Rev 03

Status : Valid

Issue Date : 2024-10-23

Type : Chemical

Substance Number : 68

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Certificate Number : CEP 2016-112 - Rev 05

Status : Valid

Issue Date : 2023-09-18

Type : Chemical

Substance Number : 68

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Certificate Number : R0-CEP 2015-323 - Rev 00

Status : Withdrawn by Holder

Issue Date : 2017-02-20

Type : Chemical

Substance Number : 68

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Certificate Number : CEP 2015-002 - Rev 01

Status : Valid

Issue Date : 2023-09-04

Type : Chemical

Substance Number : 68

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EU WC

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Atropine Sulphate EP/USP/JP

Date of Issue : 2022-05-27

Valid Till : 2025-05-26

Written Confirmation Number : WC-0006

Address of the Firm : 25/2, Main Mathura Road, Village Kalli, Ballabgarh, Faridabad-121 004, Haryana, ...

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Atropine Sulphate USP

Date of Issue : 2024-02-20

Valid Till : 2026-12-06

Written Confirmation Number : WC-0416

Address of the Firm : Plot No. 111 SIDCO Industrial Estate, Kakkalur Thiruvallur-602003 Tamil Nadu, In...

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Laurus Labs

India
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Atropine Sulphate USP

Date of Issue : 2023-07-03

Valid Till : 2025-07-02

Written Confirmation Number : WC-0213

Address of the Firm : Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakh...

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Atropine Sulphate EP

Date of Issue : 2019-01-21

Valid Till : 2022-01-20

Written Confirmation Number : WC-286

Address of the Firm : No. 8C & 9A, KIADB Industrial Area, Doddaballapur, Bangalore Dist-561023

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Atropine Sulfate USP/EP

Date of Issue : 2019-08-13

Valid Till : 2022-08-12

Written Confirmation Number : WC-0171

Address of the Firm : (Unit-III), Village-Bhagwanpur, Barwala Road, Derabassi, Dist-Mohali (Punjab)

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API Reference Price

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ESTATE,,PHAS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730053800,"product":"LL\/15\/25098 ATROPINE SULFATE (ATROPINE SULPHATE)","address":"236, OKHLA INDUSTRIAL AREA,PHASE.","city":"NEW DELHI","supplier":"C-SQUARED PHARMA","supplierCountry":"INDIA","foreign_port":"MUNICH","customer":"MANKIND PHARMA","customerCountry":"INDIA","quantity":"2.10","actualQuantity":"2.1","unit":"KGS","unitRateFc":"14500","totalValueFC":"34119.3","currency":"EUR","unitRateINR":"1365203.1","date":"28-Oct-2024","totalValueINR":"2866926.56","totalValueInUsd":"34119.3","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":"236, OKHLA INDUSTRIAL AREA,PHASE."},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730053800,"product":"LL\/15\/25098 ATROPINE SULFATE (ATROPINE SULPHATE)","address":"236, OKHLA INDUSTRIAL AREA,PHASE.","city":"NEW DELHI","supplier":"C-SQUARED PHARMA","supplierCountry":"INDIA","foreign_port":"MUNICH","customer":"MANKIND PHARMA","customerCountry":"INDIA","quantity":"3.86","actualQuantity":"3.862","unit":"KGS","unitRateFc":"14500","totalValueFC":"62747","currency":"EUR","unitRateINR":"1365203.1","date":"28-Oct-2024","totalValueINR":"5272414.47","totalValueInUsd":"62747","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":"236, OKHLA INDUSTRIAL AREA,PHASE."},{"dataSource":"API 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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":"0.73","actualQuantity":"0.726","unit":"KGS","unitRateFc":"14500","totalValueFC":"11795.5","currency":"EUR","unitRateINR":"1365203.1","date":"28-Oct-2024","totalValueINR":"991137.47","totalValueInUsd":"11795.5","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"}]
04-Jan-2021
28-Oct-2024
KGS
overview
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

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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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