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ABOUT THIS PAGE
A Lysozyme Chloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lysozyme Chloride, including repackagers and relabelers. The FDA regulates Lysozyme Chloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lysozyme Chloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Lysozyme Chloride supplier is an individual or a company that provides Lysozyme Chloride active pharmaceutical ingredient (API) or Lysozyme Chloride finished formulations upon request. The Lysozyme Chloride suppliers may include Lysozyme Chloride API manufacturers, exporters, distributors and traders.
click here to find a list of Lysozyme Chloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lysozyme Chloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Lysozyme Chloride active pharmaceutical ingredient (API) in detail. Different forms of Lysozyme Chloride DMFs exist exist since differing nations have different regulations, such as Lysozyme Chloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lysozyme Chloride DMF submitted to regulatory agencies in the US is known as a USDMF. Lysozyme Chloride USDMF includes data on Lysozyme Chloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lysozyme Chloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lysozyme Chloride 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 Lysozyme Chloride Drug Master File in Japan (Lysozyme Chloride JDMF) empowers Lysozyme Chloride 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 Lysozyme Chloride JDMF during the approval evaluation for pharmaceutical products. At the time of Lysozyme Chloride 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 Lysozyme Chloride suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Lysozyme Chloride Drug Master File in Korea (Lysozyme Chloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lysozyme Chloride. The MFDS reviews the Lysozyme Chloride KDMF as part of the drug registration process and uses the information provided in the Lysozyme Chloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lysozyme Chloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Lysozyme Chloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lysozyme Chloride suppliers with KDMF 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 Lysozyme Chloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lysozyme Chloride 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 Lysozyme Chloride 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 Lysozyme Chloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lysozyme Chloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lysozyme Chloride suppliers with NDC on PharmaCompass.
Lysozyme Chloride 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 Lysozyme Chloride 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 Lysozyme Chloride GMP manufacturer or Lysozyme Chloride GMP API supplier for your needs.
A Lysozyme Chloride CoA (Certificate of Analysis) is a formal document that attests to Lysozyme Chloride's compliance with Lysozyme Chloride specifications and serves as a tool for batch-level quality control.
Lysozyme Chloride CoA mostly includes findings from lab analyses of a specific batch. For each Lysozyme Chloride 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.
Lysozyme Chloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Lysozyme Chloride EP), Lysozyme Chloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lysozyme Chloride USP).
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