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