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Looking for 637-58-1 / Pramoxine Hydrochloride API manufacturers, exporters & distributors?

Pramoxine Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Pramoxine Hydrochloride

Synonyms

637-58-1, Pramoxine hcl, Pramocaine hydrochloride, Prax lotion, Tronothane, Pramocaine (hydrochloride)

Cas Number

637-58-1

Unique Ingredient Identifier (UNII)

88AYB867L5

About Pramoxine Hydrochloride

Pramocaine Hydrochloride is the hydrochloride salt form of pramoxine, a morpholine derivative with local anesthetic property. Pramocaine hydrochloride decreases the permeability of the neuronal membrane to sodium ions by reversibly binding to and inhibiting voltage-gated sodium channels. This results in stabilization of the membrane and, thereby inhibiting the ionic fluxes required for membrane depolarization, hence resulting in the failure to initiate a propagated action potential and subsequent conduction blockade.

Pramoxine HCl Manufacturers

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

Pramoxine HCl Suppliers

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

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

Pramoxine HCl USDMF

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

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

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

Pramoxine HCl KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Pramoxine HCl Drug Master File in Korea (Pramoxine HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pramoxine HCl. The MFDS reviews the Pramoxine HCl KDMF as part of the drug registration process and uses the information provided in the Pramoxine HCl KDMF to evaluate the safety and efficacy of the drug.

After submitting a Pramoxine HCl 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 Pramoxine HCl API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Pramoxine HCl suppliers with KDMF on PharmaCompass.

Pramoxine HCl 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 Pramoxine HCl as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Pramoxine HCl GMP

Pramoxine HCl 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 Pramoxine HCl 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 Pramoxine HCl GMP manufacturer or Pramoxine HCl GMP API supplier for your needs.

Pramoxine HCl CoA

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

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

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