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DOSAGE - SOLUTION;INTRAVENOUS - 2500MG/50ML (...DOSAGE - SOLUTION;INTRAVENOUS - 2500MG/50ML (50MG/ML)
USFDA APPLICATION NUMBER - 210660
DOSAGE - SOLUTION;INTRAVENOUS - 500MG/10ML (5...DOSAGE - SOLUTION;INTRAVENOUS - 500MG/10ML (50MG/ML)
USFDA APPLICATION NUMBER - 210660
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PharmaCompass offers a list of L-Cysteine Hydrochloride 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 Hydrochloride manufacturer or L-Cysteine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred L-Cysteine Hydrochloride manufacturer or L-Cysteine Hydrochloride supplier.
PharmaCompass also assists you with knowing the L-Cysteine Hydrochloride API Price utilized in the formulation of products. L-Cysteine Hydrochloride API Price is not always fixed or binding as the L-Cysteine Hydrochloride Price is obtained through a variety of data sources. The L-Cysteine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A L-Cysteine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Cysteine Hydrochloride, including repackagers and relabelers. The FDA regulates L-Cysteine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Cysteine Hydrochloride 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-Cysteine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Cysteine Hydrochloride supplier is an individual or a company that provides L-Cysteine Hydrochloride active pharmaceutical ingredient (API) or L-Cysteine Hydrochloride finished formulations upon request. The L-Cysteine Hydrochloride suppliers may include L-Cysteine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of L-Cysteine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Cysteine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Cysteine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of L-Cysteine Hydrochloride DMFs exist exist since differing nations have different regulations, such as L-Cysteine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-Cysteine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. L-Cysteine Hydrochloride USDMF includes data on L-Cysteine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Cysteine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-Cysteine Hydrochloride 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-Cysteine Hydrochloride Drug Master File in Japan (L-Cysteine Hydrochloride JDMF) empowers L-Cysteine Hydrochloride 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-Cysteine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of L-Cysteine Hydrochloride 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-Cysteine Hydrochloride suppliers with JDMF on PharmaCompass.
A L-Cysteine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a L-Cysteine Hydrochloride Certificate of Suitability (COS). The purpose of a L-Cysteine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of L-Cysteine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of L-Cysteine Hydrochloride to their clients by showing that a L-Cysteine Hydrochloride CEP has been issued for it. The manufacturer submits a L-Cysteine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a L-Cysteine Hydrochloride CEP holder for the record. Additionally, the data presented in the L-Cysteine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the L-Cysteine Hydrochloride DMF.
A L-Cysteine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. L-Cysteine Hydrochloride 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-Cysteine Hydrochloride 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-Cysteine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for L-Cysteine Hydrochloride 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-Cysteine Hydrochloride 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-Cysteine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a L-Cysteine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of L-Cysteine Hydrochloride suppliers with NDC on PharmaCompass.
L-Cysteine Hydrochloride 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-Cysteine Hydrochloride 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-Cysteine Hydrochloride GMP manufacturer or L-Cysteine Hydrochloride GMP API supplier for your needs.
A L-Cysteine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to L-Cysteine Hydrochloride's compliance with L-Cysteine Hydrochloride specifications and serves as a tool for batch-level quality control.
L-Cysteine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each L-Cysteine Hydrochloride 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-Cysteine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (L-Cysteine Hydrochloride EP), L-Cysteine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (L-Cysteine Hydrochloride USP).
