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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 PEG 3350 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PEG 3350, including repackagers and relabelers. The FDA regulates PEG 3350 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PEG 3350 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 3350 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A PEG 3350 supplier is an individual or a company that provides PEG 3350 active pharmaceutical ingredient (API) or PEG 3350 finished formulations upon request. The PEG 3350 suppliers may include PEG 3350 API manufacturers, exporters, distributors and traders.
click here to find a list of PEG 3350 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A PEG 3350 DMF (Drug Master File) is a document detailing the whole manufacturing process of PEG 3350 active pharmaceutical ingredient (API) in detail. Different forms of PEG 3350 DMFs exist exist since differing nations have different regulations, such as PEG 3350 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A PEG 3350 DMF submitted to regulatory agencies in the US is known as a USDMF. PEG 3350 USDMF includes data on PEG 3350's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PEG 3350 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of PEG 3350 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 3350 Drug Master File in Japan (PEG 3350 JDMF) empowers PEG 3350 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 3350 JDMF during the approval evaluation for pharmaceutical products. At the time of PEG 3350 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 3350 suppliers with JDMF on PharmaCompass.
A PEG 3350 CEP of the European Pharmacopoeia monograph is often referred to as a PEG 3350 Certificate of Suitability (COS). The purpose of a PEG 3350 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of PEG 3350 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of PEG 3350 to their clients by showing that a PEG 3350 CEP has been issued for it. The manufacturer submits a PEG 3350 CEP (COS) as part of the market authorization procedure, and it takes on the role of a PEG 3350 CEP holder for the record. Additionally, the data presented in the PEG 3350 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the PEG 3350 DMF.
A PEG 3350 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. PEG 3350 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 PEG 3350 suppliers with CEP (COS) on PharmaCompass.
PEG 3350 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 3350 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 3350 GMP manufacturer or PEG 3350 GMP API supplier for your needs.
A PEG 3350 CoA (Certificate of Analysis) is a formal document that attests to PEG 3350's compliance with PEG 3350 specifications and serves as a tool for batch-level quality control.
PEG 3350 CoA mostly includes findings from lab analyses of a specific batch. For each PEG 3350 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 3350 may be tested according to a variety of international standards, such as European Pharmacopoeia (PEG 3350 EP), PEG 3350 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (PEG 3350 USP).