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Looking for 2315-02-8 / Oxymetazoline Hydrochloride API manufacturers, exporters & distributors?

Oxymetazoline Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Oxymetazoline Hydrochloride

Synonyms

2315-02-8, Oxymetazoline hcl, Ocuclear, Afrazine, Afrin hydrochloride, Sch 9384

Cas Number

2315-02-8

Unique Ingredient Identifier (UNII)

K89MJ0S5VY

About Oxymetazoline Hydrochloride

A direct acting sympathomimetic used as a vasoconstrictor to relieve nasal congestion. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1251)

Oxymetazoline Hydrochloride Manufacturers

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

Oxymetazoline Hydrochloride Suppliers

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

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

Oxymetazoline Hydrochloride USDMF

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

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

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

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

Oxymetazoline Hydrochloride CEP

A Oxymetazoline Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Oxymetazoline Hydrochloride Certificate of Suitability (COS). The purpose of a Oxymetazoline Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Oxymetazoline Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Oxymetazoline Hydrochloride to their clients by showing that a Oxymetazoline Hydrochloride CEP has been issued for it. The manufacturer submits a Oxymetazoline Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Oxymetazoline Hydrochloride CEP holder for the record. Additionally, the data presented in the Oxymetazoline Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Oxymetazoline Hydrochloride DMF.

A Oxymetazoline Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Oxymetazoline 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 Oxymetazoline Hydrochloride suppliers with CEP (COS) on PharmaCompass.

Oxymetazoline Hydrochloride WC

A Oxymetazoline Hydrochloride written confirmation (Oxymetazoline Hydrochloride WC) is an official document issued by a regulatory agency to a Oxymetazoline Hydrochloride manufacturer, verifying that the manufacturing facility of a Oxymetazoline Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Oxymetazoline Hydrochloride APIs or Oxymetazoline Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Oxymetazoline Hydrochloride WC (written confirmation) as part of the regulatory process.

click here to find a list of Oxymetazoline Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

Oxymetazoline Hydrochloride 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 Oxymetazoline Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Oxymetazoline Hydrochloride 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 Oxymetazoline 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.

Compounded drug products

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

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

Oxymetazoline Hydrochloride GMP

Oxymetazoline 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 Oxymetazoline 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 Oxymetazoline Hydrochloride GMP manufacturer or Oxymetazoline Hydrochloride GMP API supplier for your needs.

Oxymetazoline Hydrochloride CoA

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

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

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