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PharmaCompass offers a list of Lysine 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 Lysine manufacturer or Lysine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lysine manufacturer or Lysine supplier.
PharmaCompass also assists you with knowing the Lysine API Price utilized in the formulation of products. Lysine API Price is not always fixed or binding as the Lysine Price is obtained through a variety of data sources. The Lysine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 0013CD6B-1671-4369-B1BE-F531611E50C7 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 0013CD6B-1671-4369-B1BE-F531611E50C7, including repackagers and relabelers. The FDA regulates 0013CD6B-1671-4369-B1BE-F531611E50C7 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 0013CD6B-1671-4369-B1BE-F531611E50C7 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 0013CD6B-1671-4369-B1BE-F531611E50C7 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 0013CD6B-1671-4369-B1BE-F531611E50C7 supplier is an individual or a company that provides 0013CD6B-1671-4369-B1BE-F531611E50C7 active pharmaceutical ingredient (API) or 0013CD6B-1671-4369-B1BE-F531611E50C7 finished formulations upon request. The 0013CD6B-1671-4369-B1BE-F531611E50C7 suppliers may include 0013CD6B-1671-4369-B1BE-F531611E50C7 API manufacturers, exporters, distributors and traders.
click here to find a list of 0013CD6B-1671-4369-B1BE-F531611E50C7 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 0013CD6B-1671-4369-B1BE-F531611E50C7 DMF (Drug Master File) is a document detailing the whole manufacturing process of 0013CD6B-1671-4369-B1BE-F531611E50C7 active pharmaceutical ingredient (API) in detail. Different forms of 0013CD6B-1671-4369-B1BE-F531611E50C7 DMFs exist exist since differing nations have different regulations, such as 0013CD6B-1671-4369-B1BE-F531611E50C7 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 0013CD6B-1671-4369-B1BE-F531611E50C7 DMF submitted to regulatory agencies in the US is known as a USDMF. 0013CD6B-1671-4369-B1BE-F531611E50C7 USDMF includes data on 0013CD6B-1671-4369-B1BE-F531611E50C7's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 0013CD6B-1671-4369-B1BE-F531611E50C7 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 0013CD6B-1671-4369-B1BE-F531611E50C7 Drug Master File in Japan (0013CD6B-1671-4369-B1BE-F531611E50C7 JDMF) empowers 0013CD6B-1671-4369-B1BE-F531611E50C7 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 0013CD6B-1671-4369-B1BE-F531611E50C7 JDMF during the approval evaluation for pharmaceutical products. At the time of 0013CD6B-1671-4369-B1BE-F531611E50C7 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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A 0013CD6B-1671-4369-B1BE-F531611E50C7 written confirmation (0013CD6B-1671-4369-B1BE-F531611E50C7 WC) is an official document issued by a regulatory agency to a 0013CD6B-1671-4369-B1BE-F531611E50C7 manufacturer, verifying that the manufacturing facility of a 0013CD6B-1671-4369-B1BE-F531611E50C7 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 0013CD6B-1671-4369-B1BE-F531611E50C7 APIs or 0013CD6B-1671-4369-B1BE-F531611E50C7 finished pharmaceutical products to another nation, regulatory agencies frequently require a 0013CD6B-1671-4369-B1BE-F531611E50C7 WC (written confirmation) as part of the regulatory process.
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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 0013CD6B-1671-4369-B1BE-F531611E50C7 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 0013CD6B-1671-4369-B1BE-F531611E50C7 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 0013CD6B-1671-4369-B1BE-F531611E50C7 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 0013CD6B-1671-4369-B1BE-F531611E50C7 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 0013CD6B-1671-4369-B1BE-F531611E50C7 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 0013CD6B-1671-4369-B1BE-F531611E50C7 suppliers with NDC on PharmaCompass.
0013CD6B-1671-4369-B1BE-F531611E50C7 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 0013CD6B-1671-4369-B1BE-F531611E50C7 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 0013CD6B-1671-4369-B1BE-F531611E50C7 GMP manufacturer or 0013CD6B-1671-4369-B1BE-F531611E50C7 GMP API supplier for your needs.
A 0013CD6B-1671-4369-B1BE-F531611E50C7 CoA (Certificate of Analysis) is a formal document that attests to 0013CD6B-1671-4369-B1BE-F531611E50C7's compliance with 0013CD6B-1671-4369-B1BE-F531611E50C7 specifications and serves as a tool for batch-level quality control.
0013CD6B-1671-4369-B1BE-F531611E50C7 CoA mostly includes findings from lab analyses of a specific batch. For each 0013CD6B-1671-4369-B1BE-F531611E50C7 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.
0013CD6B-1671-4369-B1BE-F531611E50C7 may be tested according to a variety of international standards, such as European Pharmacopoeia (0013CD6B-1671-4369-B1BE-F531611E50C7 EP), 0013CD6B-1671-4369-B1BE-F531611E50C7 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (0013CD6B-1671-4369-B1BE-F531611E50C7 USP).
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