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PharmaCompass offers a list of L-Carnitine HCl 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-Carnitine HCl manufacturer or L-Carnitine HCl supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred L-Carnitine HCl manufacturer or L-Carnitine HCl supplier.
PharmaCompass also assists you with knowing the L-Carnitine HCl API Price utilized in the formulation of products. L-Carnitine HCl API Price is not always fixed or binding as the L-Carnitine HCl Price is obtained through a variety of data sources. The L-Carnitine HCl Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A L-Carnitine HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Carnitine HCl, including repackagers and relabelers. The FDA regulates L-Carnitine HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Carnitine HCl 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-Carnitine HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Carnitine HCl supplier is an individual or a company that provides L-Carnitine HCl active pharmaceutical ingredient (API) or L-Carnitine HCl finished formulations upon request. The L-Carnitine HCl suppliers may include L-Carnitine HCl API manufacturers, exporters, distributors and traders.
click here to find a list of L-Carnitine HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Carnitine HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Carnitine HCl active pharmaceutical ingredient (API) in detail. Different forms of L-Carnitine HCl DMFs exist exist since differing nations have different regulations, such as L-Carnitine HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-Carnitine HCl DMF submitted to regulatory agencies in the US is known as a USDMF. L-Carnitine HCl USDMF includes data on L-Carnitine HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Carnitine HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-Carnitine HCl 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-Carnitine HCl Drug Master File in Japan (L-Carnitine HCl JDMF) empowers L-Carnitine HCl 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-Carnitine HCl JDMF during the approval evaluation for pharmaceutical products. At the time of L-Carnitine HCl 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-Carnitine HCl suppliers with JDMF on PharmaCompass.
L-Carnitine HCl 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-Carnitine HCl 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-Carnitine HCl GMP manufacturer or L-Carnitine HCl GMP API supplier for your needs.
A L-Carnitine HCl CoA (Certificate of Analysis) is a formal document that attests to L-Carnitine HCl's compliance with L-Carnitine HCl specifications and serves as a tool for batch-level quality control.
L-Carnitine HCl CoA mostly includes findings from lab analyses of a specific batch. For each L-Carnitine HCl 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-Carnitine HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (L-Carnitine HCl EP), L-Carnitine HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (L-Carnitine HCl USP).