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