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- EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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