Synopsis
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EU WC
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KDMF
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NDC API
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FDF
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Data Compilation #PharmaFlow
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
EUROAPI
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lubricants & Glidants
Fillers, Diluents & Binders
Parenteral
Coating Systems & Additives
Co-Processed Excipients
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Granulation
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Digital Content
NEWS #PharmaBuzz
Market Place
REF. STANDARDS & IMPURITIES
ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
15
PharmaCompass offers a list of L-Cysteine 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 L-Cysteine manufacturer or L-Cysteine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred L-Cysteine manufacturer or L-Cysteine supplier.
PharmaCompass also assists you with knowing the L-Cysteine API Price utilized in the formulation of products. L-Cysteine API Price is not always fixed or binding as the L-Cysteine Price is obtained through a variety of data sources. The L-Cysteine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A L-Cystin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Cystin, including repackagers and relabelers. The FDA regulates L-Cystin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Cystin 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-Cystin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Cystin supplier is an individual or a company that provides L-Cystin active pharmaceutical ingredient (API) or L-Cystin finished formulations upon request. The L-Cystin suppliers may include L-Cystin API manufacturers, exporters, distributors and traders.
click here to find a list of L-Cystin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Cystin DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Cystin active pharmaceutical ingredient (API) in detail. Different forms of L-Cystin DMFs exist exist since differing nations have different regulations, such as L-Cystin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-Cystin DMF submitted to regulatory agencies in the US is known as a USDMF. L-Cystin USDMF includes data on L-Cystin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Cystin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-Cystin 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-Cystin Drug Master File in Japan (L-Cystin JDMF) empowers L-Cystin 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-Cystin JDMF during the approval evaluation for pharmaceutical products. At the time of L-Cystin 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-Cystin suppliers with JDMF on PharmaCompass.
A L-Cystin CEP of the European Pharmacopoeia monograph is often referred to as a L-Cystin Certificate of Suitability (COS). The purpose of a L-Cystin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of L-Cystin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of L-Cystin to their clients by showing that a L-Cystin CEP has been issued for it. The manufacturer submits a L-Cystin CEP (COS) as part of the market authorization procedure, and it takes on the role of a L-Cystin CEP holder for the record. Additionally, the data presented in the L-Cystin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the L-Cystin DMF.
A L-Cystin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. L-Cystin 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-Cystin suppliers with CEP (COS) on PharmaCompass.
L-Cystin 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-Cystin 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-Cystin GMP manufacturer or L-Cystin GMP API supplier for your needs.
A L-Cystin CoA (Certificate of Analysis) is a formal document that attests to L-Cystin's compliance with L-Cystin specifications and serves as a tool for batch-level quality control.
L-Cystin CoA mostly includes findings from lab analyses of a specific batch. For each L-Cystin 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-Cystin may be tested according to a variety of international standards, such as European Pharmacopoeia (L-Cystin EP), L-Cystin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (L-Cystin USP).
