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ABOUT THIS PAGE
A Xylometazoline Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Xylometazoline Hydrochloride, including repackagers and relabelers. The FDA regulates Xylometazoline Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Xylometazoline Hydrochloride 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 Xylometazoline Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Xylometazoline Hydrochloride supplier is an individual or a company that provides Xylometazoline Hydrochloride active pharmaceutical ingredient (API) or Xylometazoline Hydrochloride finished formulations upon request. The Xylometazoline Hydrochloride suppliers may include Xylometazoline Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Xylometazoline Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Xylometazoline Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Xylometazoline Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Xylometazoline Hydrochloride DMFs exist exist since differing nations have different regulations, such as Xylometazoline Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Xylometazoline Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Xylometazoline Hydrochloride USDMF includes data on Xylometazoline Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Xylometazoline Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Xylometazoline Hydrochloride suppliers with USDMF 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 Xylometazoline Hydrochloride Drug Master File in Korea (Xylometazoline Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Xylometazoline Hydrochloride. The MFDS reviews the Xylometazoline Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Xylometazoline Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Xylometazoline Hydrochloride 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 Xylometazoline Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Xylometazoline Hydrochloride suppliers with KDMF on PharmaCompass.
A Xylometazoline Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Xylometazoline Hydrochloride Certificate of Suitability (COS). The purpose of a Xylometazoline Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Xylometazoline Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Xylometazoline Hydrochloride to their clients by showing that a Xylometazoline Hydrochloride CEP has been issued for it. The manufacturer submits a Xylometazoline Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Xylometazoline Hydrochloride CEP holder for the record. Additionally, the data presented in the Xylometazoline Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Xylometazoline Hydrochloride DMF.
A Xylometazoline Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Xylometazoline Hydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Xylometazoline Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Xylometazoline Hydrochloride written confirmation (Xylometazoline Hydrochloride WC) is an official document issued by a regulatory agency to a Xylometazoline Hydrochloride manufacturer, verifying that the manufacturing facility of a Xylometazoline Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Xylometazoline Hydrochloride APIs or Xylometazoline Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Xylometazoline Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Xylometazoline Hydrochloride 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 Xylometazoline Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Xylometazoline Hydrochloride 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 Xylometazoline Hydrochloride 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 Xylometazoline Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Xylometazoline Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Xylometazoline Hydrochloride suppliers with NDC on PharmaCompass.
Xylometazoline Hydrochloride 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 Xylometazoline Hydrochloride 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 Xylometazoline Hydrochloride GMP manufacturer or Xylometazoline Hydrochloride GMP API supplier for your needs.
A Xylometazoline Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Xylometazoline Hydrochloride's compliance with Xylometazoline Hydrochloride specifications and serves as a tool for batch-level quality control.
Xylometazoline Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Xylometazoline Hydrochloride 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.
Xylometazoline Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Xylometazoline Hydrochloride EP), Xylometazoline Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Xylometazoline Hydrochloride USP).
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