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1. Schembl34274
2. Ft-0603494
3. Ft-0656045
| Molecular Weight | 676.8 g/mol |
|---|---|
| Molecular Formula | C34H48N2O10S |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 10 |
| Rotatable Bond Count | 10 |
| Exact Mass | 676.30296691 g/mol |
| Monoisotopic Mass | 676.30296691 g/mol |
| Topological Polar Surface Area | 191 Ų |
| Heavy Atom Count | 47 |
| Formal Charge | 0 |
| Complexity | 415 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 6 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 3 |
| 1 of 2 | |
|---|---|
| Drug Name | Atropine sulfate |
| Drug Label | Atropine 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 Ingredient | Atropine sulfate |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | 1% |
| Market Status | Prescription |
| Company | Akorn |
| 2 of 2 | |
|---|---|
| Drug Name | Atropine sulfate |
| Drug Label | Atropine 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 Ingredient | Atropine sulfate |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | 1% |
| Market Status | Prescription |
| Company | Akorn |

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Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info : Withdrawn
Registration Country : Malta
Brand Name : Atropine Sulphate
Dosage Form : Solution For Injection
Dosage Strength : 0.06%W/V
Packaging :
Approval Date : 2007-07-09
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info : Withdrawn
Registration Country : Malta
Brand Name : Atropine Sulphate
Dosage Form : Solution For Injection
Dosage Strength : 5ML
Packaging :
Approval Date : 2013-05-28
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta
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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Atropin Aguettant
Dosage Form : Solution For Injection
Dosage Strength : 0.1mg/ml
Packaging :
Approval Date : 20/06/2012
Application Number : 20110416000038
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Atropine Aguettant
Dosage Form : Injectable Solution In Pre-Filled Syringe
Dosage Strength : 0.1MG
Packaging :
Approval Date : 2016-12-09
Application Number : 81510
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Atropin Bausch & Lomb
Dosage Form : Eye Drop
Dosage Strength : 10mg/ml
Packaging :
Approval Date : 11/09/1981
Application Number : 19810911000031
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Invalid
Registration Country : Malta
Brand Name : Atropine Sulfate
Dosage Form : Solution For Injection
Dosage Strength : 600MCG/ML
Packaging :
Approval Date : 2017-07-17
Application Number :
Regulatory Info : Invalid
Registration Country : Malta

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Atropine Sulfate Serra Pamies
Dosage Form : Injectable Solution
Dosage Strength : 1MG
Packaging :
Approval Date : 1966-05-01
Application Number : 43064
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Ryjunea
Dosage Form : Eye Drop
Dosage Strength : 0.1mg/ml
Packaging :
Approval Date : 02/06/2025
Application Number : 20240308000027
Regulatory Info : Approved
Registration Country : Sweden

Regulatory Info :
Registration Country : Italy
Brand Name : Atropine Sulfate
Dosage Form : Atropine 0.5Mg 5 Units Parenteral Use
Dosage Strength : 5 vials 0.5 mg 1 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy

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Regulatory Info : Authorised
Registration Country : Malta
Brand Name : Dysurgal
Dosage Form : Tablet
Dosage Strength : 0.5MG
Packaging :
Approval Date : 2023-10-27
Application Number :
Regulatory Info : Authorised
Registration Country : Malta

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Product Web Link
Virtual Booth
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info :
Registration Country : France
Brand Name :
Dosage Form : Ampoule
Dosage Strength : 600MCG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Packaging :
Regulatory Info :
Dosage : Ampoule
Dosage Strength : 600MCG/ML
Brand Name :
Approval Date :
Application Number :
Registration Country : France
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info :
Registration Country : France
Brand Name :
Dosage Form : Ampoule
Dosage Strength : 1MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Packaging :
Regulatory Info :
Dosage : Ampoule
Dosage Strength : 1MG/ML
Brand Name :
Approval Date :
Application Number :
Registration Country : France
Regulatory Info :
Registration Country : India
Atropine Sulfate; Diphenoxylate
Brand Name : Atropine Sulfate; Diph...
Dosage Form : Tablet
Dosage Strength : 2.5MG; 0.025MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Atropine Sulfate; Diphenoxylate
Dosage : Tablet
Dosage Strength : 2.5MG; 0.025MG
Brand Name : Atropine Sulfate; Diph...
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Diphenoxylate Hydrochloride; Atropine Sulfate
Brand Name : Diphenoxylate Hydrochl...
Dosage Form : Tablet
Dosage Strength : 2.5MG; 0.025MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Diphenoxylate Hydrochloride; Atropine Sulfate
Dosage : Tablet
Dosage Strength : 2.5MG; 0.025MG
Brand Name : Diphenoxylate Hydrochl...
Approval Date :
Application Number :
Registration Country : India
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Regulatory Info :
Registration Country : India
Atropine Sulfate; Chlorobutanol
Brand Name :
Dosage Form : Eye/Ear Drop
Dosage Strength : 1% W/V; 0.5% W/V
Packaging : Vial
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Packaging : Vial
Regulatory Info :
Atropine Sulfate; Chlorobutanol
Dosage : Eye/Ear Drop
Dosage Strength : 1% W/V; 0.5% W/V
Brand Name :
Approval Date :
Application Number :
Registration Country : India

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Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Ophthalmic Solution
Dosage Strength : 0.5%/W/V
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Packaging :
Regulatory Info :
Dosage : Ophthalmic Solution
Dosage Strength : 0.5%/W/V
Brand Name :
Approval Date :
Application Number :
Registration Country : India

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Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 0.5MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 0.5MG/ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India

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Regulatory Info :
Registration Country : Turkey
Brand Name :
Dosage Form : Ampoule
Dosage Strength : 20MG/2ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey

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Packaging :
Regulatory Info :
Dosage : Ampoule
Dosage Strength : 20MG/2ML
Brand Name :
Approval Date :
Application Number :
Registration Country : Turkey

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Regulatory Info :
Registration Country : Taiwan
Brand Name :
Dosage Form : Eye Drops
Dosage Strength : 10MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Taiwan

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Packaging :
Regulatory Info :
Dosage : Eye Drops
Dosage Strength : 10MG/ML
Brand Name :
Approval Date :
Application Number :
Registration Country : Taiwan

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Regulatory Info :
Registration Country : Taiwan
Brand Name :
Dosage Form : Eye Drops
Dosage Strength : 3MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Taiwan

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Packaging :
Regulatory Info :
Dosage : Eye Drops
Dosage Strength : 3MG/ML
Brand Name :
Approval Date :
Application Number :
Registration Country : Taiwan

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47
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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 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.
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).