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