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Looking for 107-21-1 / Polyethylene Glycol API manufacturers, exporters & distributors?

Polyethylene Glycol manufacturers, exporters & distributors 1

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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.

API | Excipient name

Polyethylene Glycol

Synonyms

Ethane-1,2-diol, 1,2-ethanediol, 107-21-1, Glycol, Monoethylene glycol, 1,2-dihydroxyethane

Cas Number

107-21-1

Unique Ingredient Identifier (UNII)

FC72KVT52F

About Polyethylene Glycol

A colorless, odorless, viscous dihydroxy alcohol. It has a sweet taste, but is poisonous if ingested. Ethylene glycol is the most important glycol commercially available and is manufactured on a large scale in the United States. It is used as an antifreeze and coolant, in hydraulic fluids, and in the manufacture of low-freezing dynamites and resins.

Polyethylene Glycol Manufacturers

A Polyethylene Glycol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Polyethylene Glycol, including repackagers and relabelers. The FDA regulates Polyethylene Glycol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Polyethylene Glycol 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 Polyethylene Glycol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Polyethylene Glycol Suppliers

A Polyethylene Glycol supplier is an individual or a company that provides Polyethylene Glycol active pharmaceutical ingredient (API) or Polyethylene Glycol finished formulations upon request. The Polyethylene Glycol suppliers may include Polyethylene Glycol API manufacturers, exporters, distributors and traders.

click here to find a list of Polyethylene Glycol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Polyethylene Glycol USDMF

A Polyethylene Glycol DMF (Drug Master File) is a document detailing the whole manufacturing process of Polyethylene Glycol active pharmaceutical ingredient (API) in detail. Different forms of Polyethylene Glycol DMFs exist exist since differing nations have different regulations, such as Polyethylene Glycol USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Polyethylene Glycol DMF submitted to regulatory agencies in the US is known as a USDMF. Polyethylene Glycol USDMF includes data on Polyethylene Glycol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Polyethylene Glycol USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Polyethylene Glycol suppliers with USDMF on PharmaCompass.

Polyethylene Glycol JDMF

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 Polyethylene Glycol Drug Master File in Japan (Polyethylene Glycol JDMF) empowers Polyethylene Glycol 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 Polyethylene Glycol JDMF during the approval evaluation for pharmaceutical products. At the time of Polyethylene Glycol 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 Polyethylene Glycol suppliers with JDMF on PharmaCompass.

Polyethylene Glycol CEP

A Polyethylene Glycol CEP of the European Pharmacopoeia monograph is often referred to as a Polyethylene Glycol Certificate of Suitability (COS). The purpose of a Polyethylene Glycol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Polyethylene Glycol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Polyethylene Glycol to their clients by showing that a Polyethylene Glycol CEP has been issued for it. The manufacturer submits a Polyethylene Glycol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Polyethylene Glycol CEP holder for the record. Additionally, the data presented in the Polyethylene Glycol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Polyethylene Glycol DMF.

A Polyethylene Glycol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Polyethylene Glycol 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 Polyethylene Glycol suppliers with CEP (COS) on PharmaCompass.

Polyethylene Glycol GMP

Polyethylene Glycol 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 Polyethylene Glycol 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 Polyethylene Glycol GMP manufacturer or Polyethylene Glycol GMP API supplier for your needs.

Polyethylene Glycol CoA

A Polyethylene Glycol CoA (Certificate of Analysis) is a formal document that attests to Polyethylene Glycol's compliance with Polyethylene Glycol specifications and serves as a tool for batch-level quality control.

Polyethylene Glycol CoA mostly includes findings from lab analyses of a specific batch. For each Polyethylene Glycol 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.

Polyethylene Glycol may be tested according to a variety of international standards, such as European Pharmacopoeia (Polyethylene Glycol EP), Polyethylene Glycol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Polyethylene Glycol USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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