Synopsis
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CEP/COS
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US Medicaid
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Annual Reports
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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Direct Compression
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Digital Content
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A GUANIDINE HYDROCHLORIDE API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of GUANIDINE HYDROCHLORIDE API, including repackagers and relabelers. The FDA regulates GUANIDINE HYDROCHLORIDE API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. GUANIDINE HYDROCHLORIDE API 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 HYDROCHLORIDE API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A GUANIDINE HYDROCHLORIDE API supplier is an individual or a company that provides GUANIDINE HYDROCHLORIDE API active pharmaceutical ingredient (API) or GUANIDINE HYDROCHLORIDE API finished formulations upon request. The GUANIDINE HYDROCHLORIDE API suppliers may include GUANIDINE HYDROCHLORIDE API API manufacturers, exporters, distributors and traders.
click here to find a list of GUANIDINE HYDROCHLORIDE API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A GUANIDINE HYDROCHLORIDE API DMF (Drug Master File) is a document detailing the whole manufacturing process of GUANIDINE HYDROCHLORIDE API active pharmaceutical ingredient (API) in detail. Different forms of GUANIDINE HYDROCHLORIDE API DMFs exist exist since differing nations have different regulations, such as GUANIDINE HYDROCHLORIDE API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A GUANIDINE HYDROCHLORIDE API DMF submitted to regulatory agencies in the US is known as a USDMF. GUANIDINE HYDROCHLORIDE API USDMF includes data on GUANIDINE HYDROCHLORIDE API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The GUANIDINE HYDROCHLORIDE API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of GUANIDINE HYDROCHLORIDE API 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 HYDROCHLORIDE API Drug Master File in Japan (GUANIDINE HYDROCHLORIDE API JDMF) empowers GUANIDINE HYDROCHLORIDE API 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 HYDROCHLORIDE API JDMF during the approval evaluation for pharmaceutical products. At the time of GUANIDINE HYDROCHLORIDE API 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 HYDROCHLORIDE API suppliers with JDMF on PharmaCompass.
GUANIDINE HYDROCHLORIDE API 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 HYDROCHLORIDE API 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 HYDROCHLORIDE API GMP manufacturer or GUANIDINE HYDROCHLORIDE API GMP API supplier for your needs.
A GUANIDINE HYDROCHLORIDE API CoA (Certificate of Analysis) is a formal document that attests to GUANIDINE HYDROCHLORIDE API's compliance with GUANIDINE HYDROCHLORIDE API specifications and serves as a tool for batch-level quality control.
GUANIDINE HYDROCHLORIDE API CoA mostly includes findings from lab analyses of a specific batch. For each GUANIDINE HYDROCHLORIDE API 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 HYDROCHLORIDE API may be tested according to a variety of international standards, such as European Pharmacopoeia (GUANIDINE HYDROCHLORIDE API EP), GUANIDINE HYDROCHLORIDE API JP (Japanese Pharmacopeia) and the US Pharmacopoeia (GUANIDINE HYDROCHLORIDE API USP).
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