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