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