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