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