Close
4

Athena Athena

X

Find Oxymetazoline Hydrochloride manufacturers, exporters & distributors on PharmaCompass

PharmaCompass
API SUPPLIERS
API Suppliers

API Suppliers

US DMFs Filed

US DMFs Filed

CEP/COS Certifications

CEP/COS Certifications

JDMFs Filed

JDMFs Filed

Other Certificates

Other Certificates

Other Suppliers

Other Suppliers

API REF. PRICE (USD / KG)
INTERMEDIATES

0

DOSSIERS // FDF
USA (Orange Book)

USA (Orange Book)

Europe

Europe

Canada

Canada

Australia

Australia

South Africa

South Africa

Uploaded Dossiers

Uploaded Dossiers

GLOBAL SALES (USD Million)

U.S. Medicaid

Annual Reports

0

EXCIPIENTS
PATENTS & EXCLUSIVITIES

USFDA Orange Book Patents

USFDA Exclusivities

0

DIGITAL CONTENT

Blog #PharmaFlow

0

News

REF STANDARD

EDQM

USP

JP

0

Other Listed Suppliers

SERVICES

0

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

Oxymetazoline Hydrochloride manufacturers, exporters & distributors 1

35

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 Manufacturers

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

Oxymetazoline Suppliers

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

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

Oxymetazoline USDMF

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

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

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

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

Oxymetazoline CEP

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

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

Oxymetazoline WC

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

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

Oxymetazoline 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 as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Oxymetazoline GMP

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

Oxymetazoline CoA

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

Oxymetazoline CoA mostly includes findings from lab analyses of a specific batch. For each Oxymetazoline 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Oxymetazoline EP), Oxymetazoline JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Oxymetazoline 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.
Ask Us for Pharmaceutical Supplier and Partner
Ask Us, Find A Supplier / Partner
No Commissions, No Strings Attached, Get Connected for FREE

What are you looking for?

How can we help you?

The request can't be empty

Please read our Privacy Policy carefully

You must agree to the privacy policy

The name can't be empty
The company can't be empty.
The email can't be empty Please enter a valid email.
The mobile can't be empty
Post Enquiry
POST ENQUIRY