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Looking for 56-87-1 / Lysine API manufacturers, exporters & distributors?

Lysine manufacturers, exporters & distributors 1

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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.

API | Excipient name

Lysine

Synonyms

L-lysine, 56-87-1, Lysine acid, H-lys-oh, (2s)-2,6-diaminohexanoic acid, (s)-lysine

Cas Number

56-87-1

Unique Ingredient Identifier (UNII)

K3Z4F929H6

About Lysine

An essential amino acid. It is often added to animal feed.

Lysine Manufacturers

A Lysine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lysine, including repackagers and relabelers. The FDA regulates Lysine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lysine 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 Lysine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Lysine Suppliers

A Lysine supplier is an individual or a company that provides Lysine active pharmaceutical ingredient (API) or Lysine finished formulations upon request. The Lysine suppliers may include Lysine API manufacturers, exporters, distributors and traders.

click here to find a list of Lysine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Lysine USDMF

A Lysine DMF (Drug Master File) is a document detailing the whole manufacturing process of Lysine active pharmaceutical ingredient (API) in detail. Different forms of Lysine DMFs exist exist since differing nations have different regulations, such as Lysine USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Lysine DMF submitted to regulatory agencies in the US is known as a USDMF. Lysine USDMF includes data on Lysine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lysine USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Lysine suppliers with USDMF on PharmaCompass.

Lysine JDMF

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 Lysine Drug Master File in Japan (Lysine JDMF) empowers Lysine 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 Lysine JDMF during the approval evaluation for pharmaceutical products. At the time of Lysine 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 Lysine suppliers with JDMF on PharmaCompass.

Lysine WC

A Lysine written confirmation (Lysine WC) is an official document issued by a regulatory agency to a Lysine manufacturer, verifying that the manufacturing facility of a Lysine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lysine APIs or Lysine finished pharmaceutical products to another nation, regulatory agencies frequently require a Lysine WC (written confirmation) as part of the regulatory process.

click here to find a list of Lysine suppliers with Written Confirmation (WC) on PharmaCompass.

Lysine NDC

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 Lysine as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Lysine API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Lysine 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Lysine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lysine NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Lysine suppliers with NDC on PharmaCompass.

Lysine GMP

Lysine 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 Lysine 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 Lysine GMP manufacturer or Lysine GMP API supplier for your needs.

Lysine CoA

A Lysine CoA (Certificate of Analysis) is a formal document that attests to Lysine's compliance with Lysine specifications and serves as a tool for batch-level quality control.

Lysine CoA mostly includes findings from lab analyses of a specific batch. For each Lysine 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.

Lysine may be tested according to a variety of international standards, such as European Pharmacopoeia (Lysine EP), Lysine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lysine USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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