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