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