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ABOUT THIS PAGE
A Choline Alfoscerate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Choline Alfoscerate, including repackagers and relabelers. The FDA regulates Choline Alfoscerate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Choline Alfoscerate 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 Choline Alfoscerate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Choline Alfoscerate supplier is an individual or a company that provides Choline Alfoscerate active pharmaceutical ingredient (API) or Choline Alfoscerate finished formulations upon request. The Choline Alfoscerate suppliers may include Choline Alfoscerate API manufacturers, exporters, distributors and traders.
click here to find a list of Choline Alfoscerate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Choline Alfoscerate DMF (Drug Master File) is a document detailing the whole manufacturing process of Choline Alfoscerate active pharmaceutical ingredient (API) in detail. Different forms of Choline Alfoscerate DMFs exist exist since differing nations have different regulations, such as Choline Alfoscerate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Choline Alfoscerate DMF submitted to regulatory agencies in the US is known as a USDMF. Choline Alfoscerate USDMF includes data on Choline Alfoscerate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Choline Alfoscerate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Choline Alfoscerate suppliers with USDMF 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 Choline Alfoscerate Drug Master File in Korea (Choline Alfoscerate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Choline Alfoscerate. The MFDS reviews the Choline Alfoscerate KDMF as part of the drug registration process and uses the information provided in the Choline Alfoscerate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Choline Alfoscerate 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 Choline Alfoscerate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Choline Alfoscerate suppliers with KDMF 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 Choline Alfoscerate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Choline Alfoscerate 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 Choline Alfoscerate 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 Choline Alfoscerate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Choline Alfoscerate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Choline Alfoscerate suppliers with NDC on PharmaCompass.
Choline Alfoscerate 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 Choline Alfoscerate 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 Choline Alfoscerate GMP manufacturer or Choline Alfoscerate GMP API supplier for your needs.
A Choline Alfoscerate CoA (Certificate of Analysis) is a formal document that attests to Choline Alfoscerate's compliance with Choline Alfoscerate specifications and serves as a tool for batch-level quality control.
Choline Alfoscerate CoA mostly includes findings from lab analyses of a specific batch. For each Choline Alfoscerate 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.
Choline Alfoscerate may be tested according to a variety of international standards, such as European Pharmacopoeia (Choline Alfoscerate EP), Choline Alfoscerate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Choline Alfoscerate USP).
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