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API SUPPLIERS
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USDMF
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DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML
USFDA APPLICATION NUMBER - 204307
DOSAGE - TABLET;ORAL - 2MG;200MG;30MG
USFDA APPLICATION NUMBER - 21441
DOSAGE - TABLET;ORAL - 4MG;200MG;10MG
USFDA APPLICATION NUMBER - 22113
DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG...DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22439
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 7638
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG ...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 7638
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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 Chlor-Trimeton Injection manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chlor-Trimeton Injection, including repackagers and relabelers. The FDA regulates Chlor-Trimeton Injection manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chlor-Trimeton Injection 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 Chlor-Trimeton Injection manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Chlor-Trimeton Injection supplier is an individual or a company that provides Chlor-Trimeton Injection active pharmaceutical ingredient (API) or Chlor-Trimeton Injection finished formulations upon request. The Chlor-Trimeton Injection suppliers may include Chlor-Trimeton Injection API manufacturers, exporters, distributors and traders.
click here to find a list of Chlor-Trimeton Injection suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Chlor-Trimeton Injection DMF (Drug Master File) is a document detailing the whole manufacturing process of Chlor-Trimeton Injection active pharmaceutical ingredient (API) in detail. Different forms of Chlor-Trimeton Injection DMFs exist exist since differing nations have different regulations, such as Chlor-Trimeton Injection USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chlor-Trimeton Injection DMF submitted to regulatory agencies in the US is known as a USDMF. Chlor-Trimeton Injection USDMF includes data on Chlor-Trimeton Injection's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chlor-Trimeton Injection USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Chlor-Trimeton Injection 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 Chlor-Trimeton Injection Drug Master File in Japan (Chlor-Trimeton Injection JDMF) empowers Chlor-Trimeton Injection 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 Chlor-Trimeton Injection JDMF during the approval evaluation for pharmaceutical products. At the time of Chlor-Trimeton Injection 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 Chlor-Trimeton Injection suppliers with JDMF 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 Chlor-Trimeton Injection Drug Master File in Korea (Chlor-Trimeton Injection KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Chlor-Trimeton Injection. The MFDS reviews the Chlor-Trimeton Injection KDMF as part of the drug registration process and uses the information provided in the Chlor-Trimeton Injection KDMF to evaluate the safety and efficacy of the drug.
After submitting a Chlor-Trimeton Injection 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 Chlor-Trimeton Injection API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Chlor-Trimeton Injection suppliers with KDMF on PharmaCompass.
A Chlor-Trimeton Injection written confirmation (Chlor-Trimeton Injection WC) is an official document issued by a regulatory agency to a Chlor-Trimeton Injection manufacturer, verifying that the manufacturing facility of a Chlor-Trimeton Injection active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Chlor-Trimeton Injection APIs or Chlor-Trimeton Injection finished pharmaceutical products to another nation, regulatory agencies frequently require a Chlor-Trimeton Injection WC (written confirmation) as part of the regulatory process.
click here to find a list of Chlor-Trimeton Injection 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 Chlor-Trimeton Injection as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Chlor-Trimeton Injection 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 Chlor-Trimeton Injection 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 Chlor-Trimeton Injection and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Chlor-Trimeton Injection NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Chlor-Trimeton Injection suppliers with NDC on PharmaCompass.
Chlor-Trimeton Injection 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 Chlor-Trimeton Injection 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 Chlor-Trimeton Injection GMP manufacturer or Chlor-Trimeton Injection GMP API supplier for your needs.
A Chlor-Trimeton Injection CoA (Certificate of Analysis) is a formal document that attests to Chlor-Trimeton Injection's compliance with Chlor-Trimeton Injection specifications and serves as a tool for batch-level quality control.
Chlor-Trimeton Injection CoA mostly includes findings from lab analyses of a specific batch. For each Chlor-Trimeton Injection 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.
Chlor-Trimeton Injection may be tested according to a variety of international standards, such as European Pharmacopoeia (Chlor-Trimeton Injection EP), Chlor-Trimeton Injection JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Chlor-Trimeton Injection USP).
