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