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PharmaCompass offers a list of Betaine 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 Betaine manufacturer or Betaine supplier for your needs.
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A 1-Carboxy-N,N,N-trimethylmethanaminium inner salt manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1-Carboxy-N,N,N-trimethylmethanaminium inner salt, including repackagers and relabelers. The FDA regulates 1-Carboxy-N,N,N-trimethylmethanaminium inner salt manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1-Carboxy-N,N,N-trimethylmethanaminium inner salt API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 1-Carboxy-N,N,N-trimethylmethanaminium inner salt supplier is an individual or a company that provides 1-Carboxy-N,N,N-trimethylmethanaminium inner salt active pharmaceutical ingredient (API) or 1-Carboxy-N,N,N-trimethylmethanaminium inner salt finished formulations upon request. The 1-Carboxy-N,N,N-trimethylmethanaminium inner salt suppliers may include 1-Carboxy-N,N,N-trimethylmethanaminium inner salt API manufacturers, exporters, distributors and traders.
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A 1-Carboxy-N,N,N-trimethylmethanaminium inner salt DMF (Drug Master File) is a document detailing the whole manufacturing process of 1-Carboxy-N,N,N-trimethylmethanaminium inner salt active pharmaceutical ingredient (API) in detail. Different forms of 1-Carboxy-N,N,N-trimethylmethanaminium inner salt DMFs exist exist since differing nations have different regulations, such as 1-Carboxy-N,N,N-trimethylmethanaminium inner salt USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1-Carboxy-N,N,N-trimethylmethanaminium inner salt DMF submitted to regulatory agencies in the US is known as a USDMF. 1-Carboxy-N,N,N-trimethylmethanaminium inner salt USDMF includes data on 1-Carboxy-N,N,N-trimethylmethanaminium inner salt's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1-Carboxy-N,N,N-trimethylmethanaminium inner salt USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 1-Carboxy-N,N,N-trimethylmethanaminium inner salt Drug Master File in Japan (1-Carboxy-N,N,N-trimethylmethanaminium inner salt JDMF) empowers 1-Carboxy-N,N,N-trimethylmethanaminium inner salt 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 1-Carboxy-N,N,N-trimethylmethanaminium inner salt JDMF during the approval evaluation for pharmaceutical products. At the time of 1-Carboxy-N,N,N-trimethylmethanaminium inner salt JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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A 1-Carboxy-N,N,N-trimethylmethanaminium inner salt written confirmation (1-Carboxy-N,N,N-trimethylmethanaminium inner salt WC) is an official document issued by a regulatory agency to a 1-Carboxy-N,N,N-trimethylmethanaminium inner salt manufacturer, verifying that the manufacturing facility of a 1-Carboxy-N,N,N-trimethylmethanaminium inner salt active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 1-Carboxy-N,N,N-trimethylmethanaminium inner salt APIs or 1-Carboxy-N,N,N-trimethylmethanaminium inner salt finished pharmaceutical products to another nation, regulatory agencies frequently require a 1-Carboxy-N,N,N-trimethylmethanaminium inner salt WC (written confirmation) as part of the regulatory process.
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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 1-Carboxy-N,N,N-trimethylmethanaminium inner salt as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 1-Carboxy-N,N,N-trimethylmethanaminium inner salt 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 1-Carboxy-N,N,N-trimethylmethanaminium inner salt 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 1-Carboxy-N,N,N-trimethylmethanaminium inner salt and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 1-Carboxy-N,N,N-trimethylmethanaminium inner salt NDC to their finished compounded human drug products, they may choose to do so.
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1-Carboxy-N,N,N-trimethylmethanaminium inner salt 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 1-Carboxy-N,N,N-trimethylmethanaminium inner salt 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 1-Carboxy-N,N,N-trimethylmethanaminium inner salt GMP manufacturer or 1-Carboxy-N,N,N-trimethylmethanaminium inner salt GMP API supplier for your needs.
A 1-Carboxy-N,N,N-trimethylmethanaminium inner salt CoA (Certificate of Analysis) is a formal document that attests to 1-Carboxy-N,N,N-trimethylmethanaminium inner salt's compliance with 1-Carboxy-N,N,N-trimethylmethanaminium inner salt specifications and serves as a tool for batch-level quality control.
1-Carboxy-N,N,N-trimethylmethanaminium inner salt CoA mostly includes findings from lab analyses of a specific batch. For each 1-Carboxy-N,N,N-trimethylmethanaminium inner salt 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.
1-Carboxy-N,N,N-trimethylmethanaminium inner salt may be tested according to a variety of international standards, such as European Pharmacopoeia (1-Carboxy-N,N,N-trimethylmethanaminium inner salt EP), 1-Carboxy-N,N,N-trimethylmethanaminium inner salt JP (Japanese Pharmacopeia) and the US Pharmacopoeia (1-Carboxy-N,N,N-trimethylmethanaminium inner salt USP).
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