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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 Mono Propylene Glycol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mono Propylene Glycol, including repackagers and relabelers. The FDA regulates Mono Propylene Glycol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mono 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 Mono Propylene Glycol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mono Propylene Glycol supplier is an individual or a company that provides Mono Propylene Glycol active pharmaceutical ingredient (API) or Mono Propylene Glycol finished formulations upon request. The Mono Propylene Glycol suppliers may include Mono Propylene Glycol API manufacturers, exporters, distributors and traders.
click here to find a list of Mono Propylene Glycol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mono Propylene Glycol DMF (Drug Master File) is a document detailing the whole manufacturing process of Mono Propylene Glycol active pharmaceutical ingredient (API) in detail. Different forms of Mono Propylene Glycol DMFs exist exist since differing nations have different regulations, such as Mono Propylene Glycol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mono Propylene Glycol DMF submitted to regulatory agencies in the US is known as a USDMF. Mono Propylene Glycol USDMF includes data on Mono Propylene Glycol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mono Propylene Glycol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mono 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 Mono Propylene Glycol Drug Master File in Japan (Mono Propylene Glycol JDMF) empowers Mono 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 Mono Propylene Glycol JDMF during the approval evaluation for pharmaceutical products. At the time of Mono 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 Mono Propylene Glycol suppliers with JDMF on PharmaCompass.
Mono 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 Mono 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 Mono Propylene Glycol GMP manufacturer or Mono Propylene Glycol GMP API supplier for your needs.
A Mono Propylene Glycol CoA (Certificate of Analysis) is a formal document that attests to Mono Propylene Glycol's compliance with Mono Propylene Glycol specifications and serves as a tool for batch-level quality control.
Mono Propylene Glycol CoA mostly includes findings from lab analyses of a specific batch. For each Mono 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.
Mono Propylene Glycol may be tested according to a variety of international standards, such as European Pharmacopoeia (Mono Propylene Glycol EP), Mono Propylene Glycol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mono Propylene Glycol USP).