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Looking for 536-43-6 / Dyclonine API manufacturers, exporters & distributors?

Dyclonine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Dyclonine

Synonyms

536-43-6, Dyclonine hcl, Dyclone, Dyclothane, Dyclocaine hydrochloride, Tanaclone

Cas Number

536-43-6

Unique Ingredient Identifier (UNII)

ZEC193879Q

About Dyclonine

Dyclonine Hydrochloride is the hydrochloride salt of Dyclonine, an unclassified compound with local anesthetic effect. Dyclonine reversibly binds to activated sodium channels on the neuronal membrane, thereby decreasing the neuronal membrane's permeability to sodium ions, leading to an increased threshold for excitation. This reversibly stabilizes the membrane and inhibits depolarization, leading to the failure of a propagated action potential and subsequent conduction blockade. This results in a transient and reversible loss of sensation in a localized area of the body.

Dyclonine Manufacturers

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

Dyclonine Suppliers

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

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

Dyclonine USDMF

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

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

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

Dyclonine 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 Dyclonine as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Dyclonine 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 Dyclonine 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 Dyclonine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dyclonine NDC to their finished compounded human drug products, they may choose to do so.

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

Dyclonine GMP

Dyclonine 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 Dyclonine 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 Dyclonine GMP manufacturer or Dyclonine GMP API supplier for your needs.

Dyclonine CoA

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

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

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