US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Chlorpheniramine 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 Chlorpheniramine Maleate manufacturer or Chlorpheniramine Maleate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Chlorpheniramine Maleate manufacturer or Chlorpheniramine Maleate supplier.
PharmaCompass also assists you with knowing the Chlorpheniramine Maleate API Price utilized in the formulation of products. Chlorpheniramine Maleate API Price is not always fixed or binding as the Chlorpheniramine Maleate Price is obtained through a variety of data sources. The Chlorpheniramine Maleate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Chlorpheniramine Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chlorpheniramine Maleate, including repackagers and relabelers. The FDA regulates Chlorpheniramine Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chlorpheniramine 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.
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A Chlorpheniramine Maleate supplier is an individual or a company that provides Chlorpheniramine Maleate active pharmaceutical ingredient (API) or Chlorpheniramine Maleate finished formulations upon request. The Chlorpheniramine Maleate suppliers may include Chlorpheniramine Maleate API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Chlorpheniramine Maleate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Chlorpheniramine Maleate DMF (Drug Master File) is a document detailing the whole manufacturing process of Chlorpheniramine Maleate active pharmaceutical ingredient (API) in detail. Different forms of Chlorpheniramine Maleate DMFs exist exist since differing nations have different regulations, such as Chlorpheniramine Maleate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chlorpheniramine Maleate DMF submitted to regulatory agencies in the US is known as a USDMF. Chlorpheniramine Maleate USDMF includes data on Chlorpheniramine Maleate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chlorpheniramine Maleate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Chlorpheniramine Maleate Drug Master File in Japan (Chlorpheniramine Maleate JDMF) empowers Chlorpheniramine Maleate 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 Chlorpheniramine Maleate JDMF during the approval evaluation for pharmaceutical products. At the time of Chlorpheniramine Maleate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Chlorpheniramine Maleate Drug Master File in Korea (Chlorpheniramine Maleate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Chlorpheniramine Maleate. The MFDS reviews the Chlorpheniramine Maleate KDMF as part of the drug registration process and uses the information provided in the Chlorpheniramine Maleate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Chlorpheniramine 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 Chlorpheniramine Maleate API can apply through the Korea Drug Master File (KDMF).
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A Chlorpheniramine Maleate written confirmation (Chlorpheniramine Maleate WC) is an official document issued by a regulatory agency to a Chlorpheniramine Maleate manufacturer, verifying that the manufacturing facility of a Chlorpheniramine Maleate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Chlorpheniramine Maleate APIs or Chlorpheniramine Maleate finished pharmaceutical products to another nation, regulatory agencies frequently require a Chlorpheniramine Maleate WC (written confirmation) as part of the regulatory process.
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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 Chlorpheniramine Maleate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Chlorpheniramine 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 Chlorpheniramine 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 Chlorpheniramine Maleate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Chlorpheniramine Maleate NDC to their finished compounded human drug products, they may choose to do so.
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Chlorpheniramine 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 Chlorpheniramine 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 Chlorpheniramine Maleate GMP manufacturer or Chlorpheniramine Maleate GMP API supplier for your needs.
A Chlorpheniramine Maleate CoA (Certificate of Analysis) is a formal document that attests to Chlorpheniramine Maleate's compliance with Chlorpheniramine Maleate specifications and serves as a tool for batch-level quality control.
Chlorpheniramine Maleate CoA mostly includes findings from lab analyses of a specific batch. For each Chlorpheniramine 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.
Chlorpheniramine Maleate may be tested according to a variety of international standards, such as European Pharmacopoeia (Chlorpheniramine Maleate EP), Chlorpheniramine Maleate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Chlorpheniramine Maleate USP).