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API SUPPLIERS
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ABOUT THIS PAGE
A Cellulase manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cellulase, including repackagers and relabelers. The FDA regulates Cellulase manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cellulase 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 Cellulase manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cellulase supplier is an individual or a company that provides Cellulase active pharmaceutical ingredient (API) or Cellulase finished formulations upon request. The Cellulase suppliers may include Cellulase API manufacturers, exporters, distributors and traders.
click here to find a list of Cellulase suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Cellulase Drug Master File in Japan (Cellulase JDMF) empowers Cellulase 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 Cellulase JDMF during the approval evaluation for pharmaceutical products. At the time of Cellulase 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 Cellulase suppliers with JDMF on PharmaCompass.
A Cellulase written confirmation (Cellulase WC) is an official document issued by a regulatory agency to a Cellulase manufacturer, verifying that the manufacturing facility of a Cellulase active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cellulase APIs or Cellulase finished pharmaceutical products to another nation, regulatory agencies frequently require a Cellulase WC (written confirmation) as part of the regulatory process.
click here to find a list of Cellulase suppliers with Written Confirmation (WC) on PharmaCompass.
Cellulase 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 Cellulase 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 Cellulase GMP manufacturer or Cellulase GMP API supplier for your needs.
A Cellulase CoA (Certificate of Analysis) is a formal document that attests to Cellulase's compliance with Cellulase specifications and serves as a tool for batch-level quality control.
Cellulase CoA mostly includes findings from lab analyses of a specific batch. For each Cellulase 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.
Cellulase may be tested according to a variety of international standards, such as European Pharmacopoeia (Cellulase EP), Cellulase JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cellulase USP).
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