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  • INJECTABLE;INJECTION - 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • INJECTABLE;INJECTION - 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SYRUP;ORAL - 10MG/5ML
  • INJECTABLE;INJECTION - 25MG/ML
  • INJECTABLE;INJECTION - 50MG/ML
  • TABLET;ORAL - 25MG
  • TABLET;ORAL - 50MG

Looking for 1244-76-4 / Hydroxyzine Hydrochloride API manufacturers, exporters & distributors?

Hydroxyzine Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Hydroxyzine Hydrochloride

Synonyms

Hydroxyzine hcl, 1244-76-4, Hydroxyzine monohydrochloride, Ca67jf5q4w, Mls000028602, Smr000058737

Cas Number

1244-76-4

Unique Ingredient Identifier (UNII)

CA67JF5Q4W

About Hydroxyzine Hydrochloride

A histamine H1 receptor antagonist that is effective in the treatment of chronic urticaria, dermatitis, and histamine-mediated pruritus. Unlike its major metabolite CETIRIZINE, it does cause drowsiness. It is also effective as an antiemetic, for relief of anxiety and tension, and as a sedative.

Hydroxyzine Manufacturers

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

Hydroxyzine Suppliers

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

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

Hydroxyzine USDMF

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

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

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

Hydroxyzine KDMF

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

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

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

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

Hydroxyzine CEP

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

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

Hydroxyzine WC

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

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

Hydroxyzine 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 Hydroxyzine as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Hydroxyzine GMP

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

Hydroxyzine CoA

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

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

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