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PharmaCompass offers a list of Polyethylene Glycol 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 Polyethylene Glycol manufacturer or Polyethylene Glycol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Polyethylene Glycol manufacturer or Polyethylene Glycol supplier.
PharmaCompass also assists you with knowing the Polyethylene Glycol API Price utilized in the formulation of products. Polyethylene Glycol API Price is not always fixed or binding as the Polyethylene Glycol Price is obtained through a variety of data sources. The Polyethylene Glycol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 03395_FLUKA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 03395_FLUKA, including repackagers and relabelers. The FDA regulates 03395_FLUKA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 03395_FLUKA 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 03395_FLUKA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 03395_FLUKA supplier is an individual or a company that provides 03395_FLUKA active pharmaceutical ingredient (API) or 03395_FLUKA finished formulations upon request. The 03395_FLUKA suppliers may include 03395_FLUKA API manufacturers, exporters, distributors and traders.
click here to find a list of 03395_FLUKA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 03395_FLUKA DMF (Drug Master File) is a document detailing the whole manufacturing process of 03395_FLUKA active pharmaceutical ingredient (API) in detail. Different forms of 03395_FLUKA DMFs exist exist since differing nations have different regulations, such as 03395_FLUKA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 03395_FLUKA DMF submitted to regulatory agencies in the US is known as a USDMF. 03395_FLUKA USDMF includes data on 03395_FLUKA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 03395_FLUKA USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 03395_FLUKA 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 03395_FLUKA Drug Master File in Japan (03395_FLUKA JDMF) empowers 03395_FLUKA 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 03395_FLUKA JDMF during the approval evaluation for pharmaceutical products. At the time of 03395_FLUKA 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 03395_FLUKA CEP of the European Pharmacopoeia monograph is often referred to as a 03395_FLUKA Certificate of Suitability (COS). The purpose of a 03395_FLUKA CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 03395_FLUKA EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 03395_FLUKA to their clients by showing that a 03395_FLUKA CEP has been issued for it. The manufacturer submits a 03395_FLUKA CEP (COS) as part of the market authorization procedure, and it takes on the role of a 03395_FLUKA CEP holder for the record. Additionally, the data presented in the 03395_FLUKA CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 03395_FLUKA DMF.
A 03395_FLUKA CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 03395_FLUKA CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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03395_FLUKA 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 03395_FLUKA 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 03395_FLUKA GMP manufacturer or 03395_FLUKA GMP API supplier for your needs.
A 03395_FLUKA CoA (Certificate of Analysis) is a formal document that attests to 03395_FLUKA's compliance with 03395_FLUKA specifications and serves as a tool for batch-level quality control.
03395_FLUKA CoA mostly includes findings from lab analyses of a specific batch. For each 03395_FLUKA 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.
03395_FLUKA may be tested according to a variety of international standards, such as European Pharmacopoeia (03395_FLUKA EP), 03395_FLUKA JP (Japanese Pharmacopeia) and the US Pharmacopoeia (03395_FLUKA USP).
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