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PharmaCompass offers a list of Histamine Dihydrochloride 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 Histamine Dihydrochloride manufacturer or Histamine Dihydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Histamine Dihydrochloride manufacturer or Histamine Dihydrochloride supplier.
PharmaCompass also assists you with knowing the Histamine Dihydrochloride API Price utilized in the formulation of products. Histamine Dihydrochloride API Price is not always fixed or binding as the Histamine Dihydrochloride Price is obtained through a variety of data sources. The Histamine Dihydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Histamine Dihydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Histamine Dihydrochloride, including repackagers and relabelers. The FDA regulates Histamine Dihydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Histamine Dihydrochloride 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 Histamine Dihydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Histamine Dihydrochloride supplier is an individual or a company that provides Histamine Dihydrochloride active pharmaceutical ingredient (API) or Histamine Dihydrochloride finished formulations upon request. The Histamine Dihydrochloride suppliers may include Histamine Dihydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Histamine Dihydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Histamine Dihydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Histamine Dihydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Histamine Dihydrochloride DMFs exist exist since differing nations have different regulations, such as Histamine Dihydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Histamine Dihydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Histamine Dihydrochloride USDMF includes data on Histamine Dihydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Histamine Dihydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Histamine Dihydrochloride 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 Histamine Dihydrochloride Drug Master File in Japan (Histamine Dihydrochloride JDMF) empowers Histamine Dihydrochloride 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 Histamine Dihydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Histamine Dihydrochloride 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 Histamine Dihydrochloride suppliers with JDMF on PharmaCompass.
A Histamine Dihydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Histamine Dihydrochloride Certificate of Suitability (COS). The purpose of a Histamine Dihydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Histamine Dihydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Histamine Dihydrochloride to their clients by showing that a Histamine Dihydrochloride CEP has been issued for it. The manufacturer submits a Histamine Dihydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Histamine Dihydrochloride CEP holder for the record. Additionally, the data presented in the Histamine Dihydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Histamine Dihydrochloride DMF.
A Histamine Dihydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Histamine Dihydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Histamine Dihydrochloride suppliers with CEP (COS) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Histamine Dihydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Histamine Dihydrochloride API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Histamine Dihydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Histamine Dihydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Histamine Dihydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Histamine Dihydrochloride suppliers with NDC on PharmaCompass.
Histamine Dihydrochloride 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 Histamine Dihydrochloride 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 Histamine Dihydrochloride GMP manufacturer or Histamine Dihydrochloride GMP API supplier for your needs.
A Histamine Dihydrochloride CoA (Certificate of Analysis) is a formal document that attests to Histamine Dihydrochloride's compliance with Histamine Dihydrochloride specifications and serves as a tool for batch-level quality control.
Histamine Dihydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Histamine Dihydrochloride 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.
Histamine Dihydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Histamine Dihydrochloride EP), Histamine Dihydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Histamine Dihydrochloride USP).
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