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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 Ergotidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ergotidine, including repackagers and relabelers. The FDA regulates Ergotidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ergotidine 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 Ergotidine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ergotidine supplier is an individual or a company that provides Ergotidine active pharmaceutical ingredient (API) or Ergotidine finished formulations upon request. The Ergotidine suppliers may include Ergotidine API manufacturers, exporters, distributors and traders.
click here to find a list of Ergotidine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ergotidine DMF (Drug Master File) is a document detailing the whole manufacturing process of Ergotidine active pharmaceutical ingredient (API) in detail. Different forms of Ergotidine DMFs exist exist since differing nations have different regulations, such as Ergotidine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ergotidine DMF submitted to regulatory agencies in the US is known as a USDMF. Ergotidine USDMF includes data on Ergotidine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ergotidine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ergotidine 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 Ergotidine Drug Master File in Japan (Ergotidine JDMF) empowers Ergotidine 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 Ergotidine JDMF during the approval evaluation for pharmaceutical products. At the time of Ergotidine 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 Ergotidine suppliers with JDMF on PharmaCompass.
A Ergotidine CEP of the European Pharmacopoeia monograph is often referred to as a Ergotidine Certificate of Suitability (COS). The purpose of a Ergotidine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ergotidine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ergotidine to their clients by showing that a Ergotidine CEP has been issued for it. The manufacturer submits a Ergotidine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ergotidine CEP holder for the record. Additionally, the data presented in the Ergotidine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ergotidine DMF.
A Ergotidine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ergotidine 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 Ergotidine 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 Ergotidine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ergotidine 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 Ergotidine 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 Ergotidine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ergotidine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ergotidine suppliers with NDC on PharmaCompass.
Ergotidine 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 Ergotidine 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 Ergotidine GMP manufacturer or Ergotidine GMP API supplier for your needs.
A Ergotidine CoA (Certificate of Analysis) is a formal document that attests to Ergotidine's compliance with Ergotidine specifications and serves as a tool for batch-level quality control.
Ergotidine CoA mostly includes findings from lab analyses of a specific batch. For each Ergotidine 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.
Ergotidine may be tested according to a variety of international standards, such as European Pharmacopoeia (Ergotidine EP), Ergotidine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ergotidine USP).
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