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