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API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - SOLUTION;INTRAVENOUS - 10MG/10ML (1M...DOSAGE - SOLUTION;INTRAVENOUS - 10MG/10ML (1MG/ML)
USFDA APPLICATION NUMBER - 203629
DOSAGE - SOLUTION;INTRAVENOUS - 3MG/3ML (1MG/...DOSAGE - SOLUTION;INTRAVENOUS - 3MG/3ML (1MG/ML)
USFDA APPLICATION NUMBER - 203629
DOSAGE - SOLUTION;INTRAVENOUS - 5MG/10ML (0.5...DOSAGE - SOLUTION;INTRAVENOUS - 5MG/10ML (0.5MG/ML)
USFDA APPLICATION NUMBER - 203629
DOSAGE - SOLUTION;INTRAVENOUS - 10MG/10ML (1M...DOSAGE - SOLUTION;INTRAVENOUS - 10MG/10ML (1MG/ML)
USFDA APPLICATION NUMBER - 204078
DOSAGE - SOLUTION;INTRAVENOUS - 5MG/10ML (0.5...DOSAGE - SOLUTION;INTRAVENOUS - 5MG/10ML (0.5MG/ML)
USFDA APPLICATION NUMBER - 204078
DOSAGE - SOLUTION;INTRAVENOUS - 5MG/5ML (1MG/...DOSAGE - SOLUTION;INTRAVENOUS - 5MG/5ML (1MG/ML)
USFDA APPLICATION NUMBER - 204078
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ABOUT THIS PAGE
A Neostigmine Methylsulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Neostigmine Methylsulfate, including repackagers and relabelers. The FDA regulates Neostigmine Methylsulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Neostigmine Methylsulfate 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 Neostigmine Methylsulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Neostigmine Methylsulfate supplier is an individual or a company that provides Neostigmine Methylsulfate active pharmaceutical ingredient (API) or Neostigmine Methylsulfate finished formulations upon request. The Neostigmine Methylsulfate suppliers may include Neostigmine Methylsulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Neostigmine Methylsulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Neostigmine Methylsulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Neostigmine Methylsulfate active pharmaceutical ingredient (API) in detail. Different forms of Neostigmine Methylsulfate DMFs exist exist since differing nations have different regulations, such as Neostigmine Methylsulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Neostigmine Methylsulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Neostigmine Methylsulfate USDMF includes data on Neostigmine Methylsulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Neostigmine Methylsulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Neostigmine Methylsulfate 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 Neostigmine Methylsulfate Drug Master File in Japan (Neostigmine Methylsulfate JDMF) empowers Neostigmine Methylsulfate 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 Neostigmine Methylsulfate JDMF during the approval evaluation for pharmaceutical products. At the time of Neostigmine Methylsulfate 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 Neostigmine Methylsulfate suppliers with JDMF on PharmaCompass.
A Neostigmine Methylsulfate CEP of the European Pharmacopoeia monograph is often referred to as a Neostigmine Methylsulfate Certificate of Suitability (COS). The purpose of a Neostigmine Methylsulfate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Neostigmine Methylsulfate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Neostigmine Methylsulfate to their clients by showing that a Neostigmine Methylsulfate CEP has been issued for it. The manufacturer submits a Neostigmine Methylsulfate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Neostigmine Methylsulfate CEP holder for the record. Additionally, the data presented in the Neostigmine Methylsulfate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Neostigmine Methylsulfate DMF.
A Neostigmine Methylsulfate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Neostigmine Methylsulfate 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 Neostigmine Methylsulfate suppliers with CEP (COS) on PharmaCompass.
A Neostigmine Methylsulfate written confirmation (Neostigmine Methylsulfate WC) is an official document issued by a regulatory agency to a Neostigmine Methylsulfate manufacturer, verifying that the manufacturing facility of a Neostigmine Methylsulfate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Neostigmine Methylsulfate APIs or Neostigmine Methylsulfate finished pharmaceutical products to another nation, regulatory agencies frequently require a Neostigmine Methylsulfate WC (written confirmation) as part of the regulatory process.
click here to find a list of Neostigmine Methylsulfate 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 Neostigmine Methylsulfate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Neostigmine Methylsulfate 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 Neostigmine Methylsulfate 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 Neostigmine Methylsulfate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Neostigmine Methylsulfate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Neostigmine Methylsulfate suppliers with NDC on PharmaCompass.
Neostigmine Methylsulfate 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 Neostigmine Methylsulfate 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 Neostigmine Methylsulfate GMP manufacturer or Neostigmine Methylsulfate GMP API supplier for your needs.
A Neostigmine Methylsulfate CoA (Certificate of Analysis) is a formal document that attests to Neostigmine Methylsulfate's compliance with Neostigmine Methylsulfate specifications and serves as a tool for batch-level quality control.
Neostigmine Methylsulfate CoA mostly includes findings from lab analyses of a specific batch. For each Neostigmine Methylsulfate 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.
Neostigmine Methylsulfate may be tested according to a variety of international standards, such as European Pharmacopoeia (Neostigmine Methylsulfate EP), Neostigmine Methylsulfate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Neostigmine Methylsulfate USP).
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