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PharmaCompass offers a list of Hydroxyzine Pamoate 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 Pamoate manufacturer or Hydroxyzine Pamoate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Hydroxyzine Pamoate manufacturer or Hydroxyzine Pamoate supplier.
PharmaCompass also assists you with knowing the Hydroxyzine Pamoate API Price utilized in the formulation of products. Hydroxyzine Pamoate API Price is not always fixed or binding as the Hydroxyzine Pamoate Price is obtained through a variety of data sources. The Hydroxyzine Pamoate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Hydroxyzine Pamoate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydroxyzine Pamoate, including repackagers and relabelers. The FDA regulates Hydroxyzine Pamoate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydroxyzine Pamoate 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 Pamoate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydroxyzine Pamoate supplier is an individual or a company that provides Hydroxyzine Pamoate active pharmaceutical ingredient (API) or Hydroxyzine Pamoate finished formulations upon request. The Hydroxyzine Pamoate suppliers may include Hydroxyzine Pamoate API manufacturers, exporters, distributors and traders.
click here to find a list of Hydroxyzine Pamoate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hydroxyzine Pamoate DMF (Drug Master File) is a document detailing the whole manufacturing process of Hydroxyzine Pamoate active pharmaceutical ingredient (API) in detail. Different forms of Hydroxyzine Pamoate DMFs exist exist since differing nations have different regulations, such as Hydroxyzine Pamoate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hydroxyzine Pamoate DMF submitted to regulatory agencies in the US is known as a USDMF. Hydroxyzine Pamoate USDMF includes data on Hydroxyzine Pamoate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hydroxyzine Pamoate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hydroxyzine Pamoate suppliers with USDMF on PharmaCompass.
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 Hydroxyzine Pamoate Drug Master File in Japan (Hydroxyzine Pamoate JDMF) empowers Hydroxyzine Pamoate 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 Hydroxyzine Pamoate JDMF during the approval evaluation for pharmaceutical products. At the time of Hydroxyzine Pamoate 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 Hydroxyzine Pamoate suppliers with JDMF 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 Hydroxyzine Pamoate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hydroxyzine Pamoate 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 Hydroxyzine Pamoate 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 Hydroxyzine Pamoate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hydroxyzine Pamoate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hydroxyzine Pamoate suppliers with NDC on PharmaCompass.
Hydroxyzine Pamoate 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 Pamoate 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 Pamoate GMP manufacturer or Hydroxyzine Pamoate GMP API supplier for your needs.
A Hydroxyzine Pamoate CoA (Certificate of Analysis) is a formal document that attests to Hydroxyzine Pamoate's compliance with Hydroxyzine Pamoate specifications and serves as a tool for batch-level quality control.
Hydroxyzine Pamoate CoA mostly includes findings from lab analyses of a specific batch. For each Hydroxyzine Pamoate 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 Pamoate may be tested according to a variety of international standards, such as European Pharmacopoeia (Hydroxyzine Pamoate EP), Hydroxyzine Pamoate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hydroxyzine Pamoate USP).
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