API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
Other Certificates
0
Other Suppliers
0
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
U.S. Medicaid
0
Annual Reports
0
0
12
PharmaCompass offers a list of Mono Propylene 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 Mono Propylene Glycol manufacturer or Mono Propylene Glycol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mono Propylene Glycol manufacturer or Mono Propylene Glycol supplier.
PharmaCompass also assists you with knowing the Mono Propylene Glycol API Price utilized in the formulation of products. Mono Propylene Glycol API Price is not always fixed or binding as the Mono Propylene Glycol Price is obtained through a variety of data sources. The Mono Propylene Glycol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A propylene-glycol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of propylene-glycol, including repackagers and relabelers. The FDA regulates propylene-glycol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. propylene-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 propylene-glycol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A propylene-glycol supplier is an individual or a company that provides propylene-glycol active pharmaceutical ingredient (API) or propylene-glycol finished formulations upon request. The propylene-glycol suppliers may include propylene-glycol API manufacturers, exporters, distributors and traders.
click here to find a list of propylene-glycol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A propylene-glycol DMF (Drug Master File) is a document detailing the whole manufacturing process of propylene-glycol active pharmaceutical ingredient (API) in detail. Different forms of propylene-glycol DMFs exist exist since differing nations have different regulations, such as propylene-glycol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A propylene-glycol DMF submitted to regulatory agencies in the US is known as a USDMF. propylene-glycol USDMF includes data on propylene-glycol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The propylene-glycol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of propylene-glycol 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 propylene-glycol Drug Master File in Japan (propylene-glycol JDMF) empowers propylene-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 propylene-glycol JDMF during the approval evaluation for pharmaceutical products. At the time of propylene-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 propylene-glycol suppliers with JDMF on PharmaCompass.
propylene-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 propylene-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 propylene-glycol GMP manufacturer or propylene-glycol GMP API supplier for your needs.
A propylene-glycol CoA (Certificate of Analysis) is a formal document that attests to propylene-glycol's compliance with propylene-glycol specifications and serves as a tool for batch-level quality control.
propylene-glycol CoA mostly includes findings from lab analyses of a specific batch. For each propylene-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.
propylene-glycol may be tested according to a variety of international standards, such as European Pharmacopoeia (propylene-glycol EP), propylene-glycol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (propylene-glycol USP).