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