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API SUPPLIERS
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USDMF
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DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - ...DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19111
DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - ...DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2.8MG BASE/5ML;EQ 14.7MG BASE/5ML
USFDA APPLICATION NUMBER - 207768
DOSAGE - SYRUP;ORAL - 2MG/5ML
USFDA APPLICATION NUMBER - 88251
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EUROAPI
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ABOUT THIS PAGE
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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 Dexchlorpheniramine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dexchlorpheniramine, including repackagers and relabelers. The FDA regulates Dexchlorpheniramine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dexchlorpheniramine 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 Dexchlorpheniramine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dexchlorpheniramine supplier is an individual or a company that provides Dexchlorpheniramine active pharmaceutical ingredient (API) or Dexchlorpheniramine finished formulations upon request. The Dexchlorpheniramine suppliers may include Dexchlorpheniramine API manufacturers, exporters, distributors and traders.
click here to find a list of Dexchlorpheniramine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dexchlorpheniramine DMF (Drug Master File) is a document detailing the whole manufacturing process of Dexchlorpheniramine active pharmaceutical ingredient (API) in detail. Different forms of Dexchlorpheniramine DMFs exist exist since differing nations have different regulations, such as Dexchlorpheniramine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dexchlorpheniramine DMF submitted to regulatory agencies in the US is known as a USDMF. Dexchlorpheniramine USDMF includes data on Dexchlorpheniramine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dexchlorpheniramine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dexchlorpheniramine 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 Dexchlorpheniramine Drug Master File in Korea (Dexchlorpheniramine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dexchlorpheniramine. The MFDS reviews the Dexchlorpheniramine KDMF as part of the drug registration process and uses the information provided in the Dexchlorpheniramine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dexchlorpheniramine 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 Dexchlorpheniramine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dexchlorpheniramine suppliers with KDMF on PharmaCompass.
A Dexchlorpheniramine CEP of the European Pharmacopoeia monograph is often referred to as a Dexchlorpheniramine Certificate of Suitability (COS). The purpose of a Dexchlorpheniramine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dexchlorpheniramine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dexchlorpheniramine to their clients by showing that a Dexchlorpheniramine CEP has been issued for it. The manufacturer submits a Dexchlorpheniramine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dexchlorpheniramine CEP holder for the record. Additionally, the data presented in the Dexchlorpheniramine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dexchlorpheniramine DMF.
A Dexchlorpheniramine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dexchlorpheniramine 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 Dexchlorpheniramine suppliers with CEP (COS) on PharmaCompass.
A Dexchlorpheniramine written confirmation (Dexchlorpheniramine WC) is an official document issued by a regulatory agency to a Dexchlorpheniramine manufacturer, verifying that the manufacturing facility of a Dexchlorpheniramine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dexchlorpheniramine APIs or Dexchlorpheniramine finished pharmaceutical products to another nation, regulatory agencies frequently require a Dexchlorpheniramine WC (written confirmation) as part of the regulatory process.
click here to find a list of Dexchlorpheniramine 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 Dexchlorpheniramine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dexchlorpheniramine 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 Dexchlorpheniramine 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 Dexchlorpheniramine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dexchlorpheniramine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dexchlorpheniramine suppliers with NDC on PharmaCompass.
Dexchlorpheniramine 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 Dexchlorpheniramine 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 Dexchlorpheniramine GMP manufacturer or Dexchlorpheniramine GMP API supplier for your needs.
A Dexchlorpheniramine CoA (Certificate of Analysis) is a formal document that attests to Dexchlorpheniramine's compliance with Dexchlorpheniramine specifications and serves as a tool for batch-level quality control.
Dexchlorpheniramine CoA mostly includes findings from lab analyses of a specific batch. For each Dexchlorpheniramine 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.
Dexchlorpheniramine may be tested according to a variety of international standards, such as European Pharmacopoeia (Dexchlorpheniramine EP), Dexchlorpheniramine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dexchlorpheniramine USP).
