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ABOUT THIS PAGE
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PharmaCompass offers a list of Serine 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 Serine manufacturer or Serine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Serine manufacturer or Serine supplier.
PharmaCompass also assists you with knowing the Serine API Price utilized in the formulation of products. Serine API Price is not always fixed or binding as the Serine Price is obtained through a variety of data sources. The Serine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A L-Serin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Serin, including repackagers and relabelers. The FDA regulates L-Serin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Serin 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 L-Serin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Serin supplier is an individual or a company that provides L-Serin active pharmaceutical ingredient (API) or L-Serin finished formulations upon request. The L-Serin suppliers may include L-Serin API manufacturers, exporters, distributors and traders.
click here to find a list of L-Serin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Serin DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Serin active pharmaceutical ingredient (API) in detail. Different forms of L-Serin DMFs exist exist since differing nations have different regulations, such as L-Serin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-Serin DMF submitted to regulatory agencies in the US is known as a USDMF. L-Serin USDMF includes data on L-Serin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Serin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-Serin 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 L-Serin Drug Master File in Japan (L-Serin JDMF) empowers L-Serin 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 L-Serin JDMF during the approval evaluation for pharmaceutical products. At the time of L-Serin 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 L-Serin suppliers with JDMF on PharmaCompass.
A L-Serin CEP of the European Pharmacopoeia monograph is often referred to as a L-Serin Certificate of Suitability (COS). The purpose of a L-Serin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of L-Serin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of L-Serin to their clients by showing that a L-Serin CEP has been issued for it. The manufacturer submits a L-Serin CEP (COS) as part of the market authorization procedure, and it takes on the role of a L-Serin CEP holder for the record. Additionally, the data presented in the L-Serin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the L-Serin DMF.
A L-Serin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. L-Serin 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 L-Serin suppliers with CEP (COS) 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 L-Serin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for L-Serin 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 L-Serin 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 L-Serin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a L-Serin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of L-Serin suppliers with NDC on PharmaCompass.
L-Serin 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 L-Serin 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 L-Serin GMP manufacturer or L-Serin GMP API supplier for your needs.
A L-Serin CoA (Certificate of Analysis) is a formal document that attests to L-Serin's compliance with L-Serin specifications and serves as a tool for batch-level quality control.
L-Serin CoA mostly includes findings from lab analyses of a specific batch. For each L-Serin 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.
L-Serin may be tested according to a variety of international standards, such as European Pharmacopoeia (L-Serin EP), L-Serin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (L-Serin USP).
