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PharmaCompass offers a list of Dexchloropheniramine 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 Dexchloropheniramine Maleate manufacturer or Dexchloropheniramine Maleate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dexchloropheniramine Maleate manufacturer or Dexchloropheniramine Maleate supplier.
PharmaCompass also assists you with knowing the Dexchloropheniramine Maleate API Price utilized in the formulation of products. Dexchloropheniramine Maleate API Price is not always fixed or binding as the Dexchloropheniramine Maleate Price is obtained through a variety of data sources. The Dexchloropheniramine Maleate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dexchloropheniramine Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dexchloropheniramine Maleate, including repackagers and relabelers. The FDA regulates Dexchloropheniramine Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dexchloropheniramine Maleate 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 Dexchloropheniramine Maleate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dexchloropheniramine Maleate supplier is an individual or a company that provides Dexchloropheniramine Maleate active pharmaceutical ingredient (API) or Dexchloropheniramine Maleate finished formulations upon request. The Dexchloropheniramine Maleate suppliers may include Dexchloropheniramine Maleate API manufacturers, exporters, distributors and traders.
click here to find a list of Dexchloropheniramine Maleate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dexchloropheniramine Maleate DMF (Drug Master File) is a document detailing the whole manufacturing process of Dexchloropheniramine Maleate active pharmaceutical ingredient (API) in detail. Different forms of Dexchloropheniramine Maleate DMFs exist exist since differing nations have different regulations, such as Dexchloropheniramine Maleate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dexchloropheniramine Maleate DMF submitted to regulatory agencies in the US is known as a USDMF. Dexchloropheniramine Maleate USDMF includes data on Dexchloropheniramine Maleate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dexchloropheniramine Maleate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dexchloropheniramine Maleate suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Dexchloropheniramine Maleate Drug Master File in Korea (Dexchloropheniramine Maleate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dexchloropheniramine Maleate. The MFDS reviews the Dexchloropheniramine Maleate KDMF as part of the drug registration process and uses the information provided in the Dexchloropheniramine Maleate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dexchloropheniramine Maleate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Dexchloropheniramine Maleate API can apply through the Korea Drug Master File (KDMF).
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A Dexchloropheniramine Maleate CEP of the European Pharmacopoeia monograph is often referred to as a Dexchloropheniramine Maleate Certificate of Suitability (COS). The purpose of a Dexchloropheniramine Maleate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dexchloropheniramine Maleate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dexchloropheniramine Maleate to their clients by showing that a Dexchloropheniramine Maleate CEP has been issued for it. The manufacturer submits a Dexchloropheniramine Maleate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dexchloropheniramine Maleate CEP holder for the record. Additionally, the data presented in the Dexchloropheniramine Maleate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dexchloropheniramine Maleate DMF.
A Dexchloropheniramine Maleate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dexchloropheniramine Maleate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Dexchloropheniramine Maleate written confirmation (Dexchloropheniramine Maleate WC) is an official document issued by a regulatory agency to a Dexchloropheniramine Maleate manufacturer, verifying that the manufacturing facility of a Dexchloropheniramine Maleate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dexchloropheniramine Maleate APIs or Dexchloropheniramine Maleate finished pharmaceutical products to another nation, regulatory agencies frequently require a Dexchloropheniramine Maleate WC (written confirmation) as part of the regulatory process.
click here to find a list of Dexchloropheniramine Maleate suppliers with Written Confirmation (WC) 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 Dexchloropheniramine Maleate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dexchloropheniramine Maleate 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 Dexchloropheniramine Maleate 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 Dexchloropheniramine Maleate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dexchloropheniramine Maleate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dexchloropheniramine Maleate suppliers with NDC on PharmaCompass.
Dexchloropheniramine Maleate 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 Dexchloropheniramine Maleate 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 Dexchloropheniramine Maleate GMP manufacturer or Dexchloropheniramine Maleate GMP API supplier for your needs.
A Dexchloropheniramine Maleate CoA (Certificate of Analysis) is a formal document that attests to Dexchloropheniramine Maleate's compliance with Dexchloropheniramine Maleate specifications and serves as a tool for batch-level quality control.
Dexchloropheniramine Maleate CoA mostly includes findings from lab analyses of a specific batch. For each Dexchloropheniramine Maleate 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.
Dexchloropheniramine Maleate may be tested according to a variety of international standards, such as European Pharmacopoeia (Dexchloropheniramine Maleate EP), Dexchloropheniramine Maleate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dexchloropheniramine Maleate USP).