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API SUPPLIERS
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USDMF
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EUROAPI
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ABOUT THIS PAGE
32
PharmaCompass offers a list of Lauromacrogol 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 Lauromacrogol manufacturer or Lauromacrogol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lauromacrogol manufacturer or Lauromacrogol supplier.
PharmaCompass also assists you with knowing the Lauromacrogol API Price utilized in the formulation of products. Lauromacrogol API Price is not always fixed or binding as the Lauromacrogol Price is obtained through a variety of data sources. The Lauromacrogol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A PEG-400 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PEG-400, including repackagers and relabelers. The FDA regulates PEG-400 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PEG-400 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 PEG-400 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A PEG-400 supplier is an individual or a company that provides PEG-400 active pharmaceutical ingredient (API) or PEG-400 finished formulations upon request. The PEG-400 suppliers may include PEG-400 API manufacturers, exporters, distributors and traders.
click here to find a list of PEG-400 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A PEG-400 DMF (Drug Master File) is a document detailing the whole manufacturing process of PEG-400 active pharmaceutical ingredient (API) in detail. Different forms of PEG-400 DMFs exist exist since differing nations have different regulations, such as PEG-400 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A PEG-400 DMF submitted to regulatory agencies in the US is known as a USDMF. PEG-400 USDMF includes data on PEG-400's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PEG-400 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of PEG-400 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 PEG-400 Drug Master File in Japan (PEG-400 JDMF) empowers PEG-400 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 PEG-400 JDMF during the approval evaluation for pharmaceutical products. At the time of PEG-400 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 PEG-400 suppliers with JDMF 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 PEG-400 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for PEG-400 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 PEG-400 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 PEG-400 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a PEG-400 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of PEG-400 suppliers with NDC on PharmaCompass.
PEG-400 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 PEG-400 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 PEG-400 GMP manufacturer or PEG-400 GMP API supplier for your needs.
A PEG-400 CoA (Certificate of Analysis) is a formal document that attests to PEG-400's compliance with PEG-400 specifications and serves as a tool for batch-level quality control.
PEG-400 CoA mostly includes findings from lab analyses of a specific batch. For each PEG-400 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.
PEG-400 may be tested according to a variety of international standards, such as European Pharmacopoeia (PEG-400 EP), PEG-400 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (PEG-400 USP).
