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Looking for 10328-34-4 / Cetalkonium API manufacturers, exporters & distributors?

Cetalkonium manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Cetalkonium 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 Cetalkonium manufacturer or Cetalkonium supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cetalkonium manufacturer or Cetalkonium supplier.

PharmaCompass also assists you with knowing the Cetalkonium API Price utilized in the formulation of products. Cetalkonium API Price is not always fixed or binding as the Cetalkonium Price is obtained through a variety of data sources. The Cetalkonium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Cetalkonium

Synonyms

10328-34-4, Cetyldimethylbenzylammonium, Cetalkonium ion, Cetalkonium cation, Benzyl-hexadecyl-dimethylazanium, Benzyldimethylhexadecylammonium

Cas Number

10328-34-4

Unique Ingredient Identifier (UNII)

FHG725432Z

About Cetalkonium

Cetalkonium is a C16 alkyl benzalkonium chloride derivative with an amphipathic property which allows it to be used in different types of formulations. It is a quaternary ammonium salt that acts as an antiseptic against a variety of bacteria and fungi. Cetalkonium is approved by the FDA for its use in over-the-counter products as a skin protectant. By Health Canada, it is also approved for its use in over-the-counter products.

Cetalkonium Chloride Manufacturers

A Cetalkonium Chloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cetalkonium Chloride, including repackagers and relabelers. The FDA regulates Cetalkonium Chloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cetalkonium Chloride 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 Cetalkonium Chloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Cetalkonium Chloride Suppliers

A Cetalkonium Chloride supplier is an individual or a company that provides Cetalkonium Chloride active pharmaceutical ingredient (API) or Cetalkonium Chloride finished formulations upon request. The Cetalkonium Chloride suppliers may include Cetalkonium Chloride API manufacturers, exporters, distributors and traders.

click here to find a list of Cetalkonium Chloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Cetalkonium Chloride USDMF

A Cetalkonium Chloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Cetalkonium Chloride active pharmaceutical ingredient (API) in detail. Different forms of Cetalkonium Chloride DMFs exist exist since differing nations have different regulations, such as Cetalkonium Chloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Cetalkonium Chloride DMF submitted to regulatory agencies in the US is known as a USDMF. Cetalkonium Chloride USDMF includes data on Cetalkonium Chloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cetalkonium Chloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Cetalkonium Chloride suppliers with USDMF on PharmaCompass.

Cetalkonium Chloride JDMF

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 Cetalkonium Chloride Drug Master File in Japan (Cetalkonium Chloride JDMF) empowers Cetalkonium Chloride 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 Cetalkonium Chloride JDMF during the approval evaluation for pharmaceutical products. At the time of Cetalkonium Chloride 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 Cetalkonium Chloride suppliers with JDMF on PharmaCompass.

Cetalkonium Chloride NDC

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 Cetalkonium Chloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Cetalkonium Chloride API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Cetalkonium Chloride 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Cetalkonium Chloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cetalkonium Chloride NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Cetalkonium Chloride suppliers with NDC on PharmaCompass.

Cetalkonium Chloride GMP

Cetalkonium Chloride 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 Cetalkonium Chloride 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 Cetalkonium Chloride GMP manufacturer or Cetalkonium Chloride GMP API supplier for your needs.

Cetalkonium Chloride CoA

A Cetalkonium Chloride CoA (Certificate of Analysis) is a formal document that attests to Cetalkonium Chloride's compliance with Cetalkonium Chloride specifications and serves as a tool for batch-level quality control.

Cetalkonium Chloride CoA mostly includes findings from lab analyses of a specific batch. For each Cetalkonium Chloride 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.

Cetalkonium Chloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Cetalkonium Chloride EP), Cetalkonium Chloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cetalkonium Chloride USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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