API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
EU WC
0
Listed Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
0
Annual Reports
0
89
PharmaCompass offers a list of Glycerine 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 Glycerine manufacturer or Glycerine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Glycerine manufacturer or Glycerine supplier.
PharmaCompass also assists you with knowing the Glycerine API Price utilized in the formulation of products. Glycerine API Price is not always fixed or binding as the Glycerine Price is obtained through a variety of data sources. The Glycerine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Glycerine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glycerine, including repackagers and relabelers. The FDA regulates Glycerine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glycerine 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 Glycerine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glycerine supplier is an individual or a company that provides Glycerine active pharmaceutical ingredient (API) or Glycerine finished formulations upon request. The Glycerine suppliers may include Glycerine API manufacturers, exporters, distributors and traders.
click here to find a list of Glycerine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Glycerine DMF (Drug Master File) is a document detailing the whole manufacturing process of Glycerine active pharmaceutical ingredient (API) in detail. Different forms of Glycerine DMFs exist exist since differing nations have different regulations, such as Glycerine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glycerine DMF submitted to regulatory agencies in the US is known as a USDMF. Glycerine USDMF includes data on Glycerine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glycerine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Glycerine 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 Glycerine Drug Master File in Japan (Glycerine JDMF) empowers Glycerine 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 Glycerine JDMF during the approval evaluation for pharmaceutical products. At the time of Glycerine 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 Glycerine suppliers with JDMF on PharmaCompass.
Glycerine 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 Glycerine 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 Glycerine GMP manufacturer or Glycerine GMP API supplier for your needs.
A Glycerine CoA (Certificate of Analysis) is a formal document that attests to Glycerine's compliance with Glycerine specifications and serves as a tool for batch-level quality control.
Glycerine CoA mostly includes findings from lab analyses of a specific batch. For each Glycerine 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.
Glycerine may be tested according to a variety of international standards, such as European Pharmacopoeia (Glycerine EP), Glycerine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Glycerine USP).