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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.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Betaine manufacturer or Betaine supplier.
PharmaCompass also assists you with knowing the Betaine API Price utilized in the formulation of products. Betaine API Price is not always fixed or binding as the Betaine Price is obtained through a variety of data sources. The Betaine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Betaine Hydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betaine Hydrate, including repackagers and relabelers. The FDA regulates Betaine Hydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betaine Hydrate 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 Betaine Hydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Betaine Hydrate supplier is an individual or a company that provides Betaine Hydrate active pharmaceutical ingredient (API) or Betaine Hydrate finished formulations upon request. The Betaine Hydrate suppliers may include Betaine Hydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Betaine Hydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Betaine Hydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Betaine Hydrate active pharmaceutical ingredient (API) in detail. Different forms of Betaine Hydrate DMFs exist exist since differing nations have different regulations, such as Betaine Hydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Betaine Hydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Betaine Hydrate USDMF includes data on Betaine Hydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Betaine Hydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Betaine Hydrate 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 Betaine Hydrate Drug Master File in Japan (Betaine Hydrate JDMF) empowers Betaine Hydrate 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 Betaine Hydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Betaine Hydrate 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 Betaine Hydrate suppliers with JDMF on PharmaCompass.
A Betaine Hydrate written confirmation (Betaine Hydrate WC) is an official document issued by a regulatory agency to a Betaine Hydrate manufacturer, verifying that the manufacturing facility of a Betaine Hydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Betaine Hydrate APIs or Betaine Hydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Betaine Hydrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Betaine Hydrate 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 Betaine Hydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Betaine Hydrate 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 Betaine Hydrate 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 Betaine Hydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Betaine Hydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Betaine Hydrate suppliers with NDC on PharmaCompass.
Betaine Hydrate 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 Betaine Hydrate 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 Betaine Hydrate GMP manufacturer or Betaine Hydrate GMP API supplier for your needs.
A Betaine Hydrate CoA (Certificate of Analysis) is a formal document that attests to Betaine Hydrate's compliance with Betaine Hydrate specifications and serves as a tool for batch-level quality control.
Betaine Hydrate CoA mostly includes findings from lab analyses of a specific batch. For each Betaine Hydrate 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.
Betaine Hydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Betaine Hydrate EP), Betaine Hydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Betaine Hydrate USP).
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