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