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API SUPPLIERS
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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Regulatory Info : Withdrawn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Regulatory Info : Withdrawn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Regulatory Info : Withdrawn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Regulatory Info : Withdrawn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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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.
Regulatory Info :
Registration Country : France
Brand Name :
Dosage Form : Ampoule
Dosage Strength : 1MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
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
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
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
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DOSAGE - TABLET;ORAL - 0.025MG;2.5MG
USFDA APPLICATION NUMBER - 12462
DOSAGE - INJECTABLE;INJECTION - 0.14MG/ML;10M...DOSAGE - INJECTABLE;INJECTION - 0.14MG/ML;10MG/ML
USFDA APPLICATION NUMBER - 19678
DOSAGE - SOLUTION;INTRAVENOUS - 0.25MG/5ML (0...DOSAGE - SOLUTION;INTRAVENOUS - 0.25MG/5ML (0.05MG/ML)
USFDA APPLICATION NUMBER - 21146
DOSAGE - SOLUTION;INTRAVENOUS - 0.5MG/5ML (0....DOSAGE - SOLUTION;INTRAVENOUS - 0.5MG/5ML (0.1MG/ML)
USFDA APPLICATION NUMBER - 21146
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
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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.
A Atropinol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Atropinol, including repackagers and relabelers. The FDA regulates Atropinol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Atropinol 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 Atropinol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Atropinol supplier is an individual or a company that provides Atropinol active pharmaceutical ingredient (API) or Atropinol finished formulations upon request. The Atropinol suppliers may include Atropinol API manufacturers, exporters, distributors and traders.
click here to find a list of Atropinol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Atropinol DMF (Drug Master File) is a document detailing the whole manufacturing process of Atropinol active pharmaceutical ingredient (API) in detail. Different forms of Atropinol DMFs exist exist since differing nations have different regulations, such as Atropinol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Atropinol DMF submitted to regulatory agencies in the US is known as a USDMF. Atropinol USDMF includes data on Atropinol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Atropinol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Atropinol 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 Atropinol Drug Master File in Japan (Atropinol JDMF) empowers Atropinol 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 Atropinol JDMF during the approval evaluation for pharmaceutical products. At the time of Atropinol 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 Atropinol 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 Atropinol Drug Master File in Korea (Atropinol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Atropinol. The MFDS reviews the Atropinol KDMF as part of the drug registration process and uses the information provided in the Atropinol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Atropinol 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 Atropinol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Atropinol suppliers with KDMF on PharmaCompass.
A Atropinol CEP of the European Pharmacopoeia monograph is often referred to as a Atropinol Certificate of Suitability (COS). The purpose of a Atropinol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Atropinol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Atropinol to their clients by showing that a Atropinol CEP has been issued for it. The manufacturer submits a Atropinol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Atropinol CEP holder for the record. Additionally, the data presented in the Atropinol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Atropinol DMF.
A Atropinol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Atropinol 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 Atropinol suppliers with CEP (COS) on PharmaCompass.
A Atropinol written confirmation (Atropinol WC) is an official document issued by a regulatory agency to a Atropinol manufacturer, verifying that the manufacturing facility of a Atropinol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Atropinol APIs or Atropinol finished pharmaceutical products to another nation, regulatory agencies frequently require a Atropinol WC (written confirmation) as part of the regulatory process.
click here to find a list of Atropinol 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 Atropinol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Atropinol 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 Atropinol 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 Atropinol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Atropinol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Atropinol suppliers with NDC on PharmaCompass.
Atropinol 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 Atropinol 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 Atropinol GMP manufacturer or Atropinol GMP API supplier for your needs.
A Atropinol CoA (Certificate of Analysis) is a formal document that attests to Atropinol's compliance with Atropinol specifications and serves as a tool for batch-level quality control.
Atropinol CoA mostly includes findings from lab analyses of a specific batch. For each Atropinol 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.
Atropinol may be tested according to a variety of international standards, such as European Pharmacopoeia (Atropinol EP), Atropinol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Atropinol USP).
