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API SUPPLIERS
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USDMF
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DOSAGE - SOLUTION;ORAL - 5MG/5ML
USFDA APPLICATION NUMBER - 22155
DOSAGE - CAPSULE;ORAL - 10MG
USFDA APPLICATION NUMBER - 22429
DOSAGE - CAPSULE;ORAL - 5MG
USFDA APPLICATION NUMBER - 22429
Related Excipient Companies
EUROAPI
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ABOUT THIS PAGE
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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 Cetzine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cetzine, including repackagers and relabelers. The FDA regulates Cetzine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cetzine 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 Cetzine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cetzine supplier is an individual or a company that provides Cetzine active pharmaceutical ingredient (API) or Cetzine finished formulations upon request. The Cetzine suppliers may include Cetzine API manufacturers, exporters, distributors and traders.
click here to find a list of Cetzine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cetzine DMF (Drug Master File) is a document detailing the whole manufacturing process of Cetzine active pharmaceutical ingredient (API) in detail. Different forms of Cetzine DMFs exist exist since differing nations have different regulations, such as Cetzine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cetzine DMF submitted to regulatory agencies in the US is known as a USDMF. Cetzine USDMF includes data on Cetzine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cetzine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cetzine 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 Cetzine Drug Master File in Japan (Cetzine JDMF) empowers Cetzine 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 Cetzine JDMF during the approval evaluation for pharmaceutical products. At the time of Cetzine 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 Cetzine 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 Cetzine Drug Master File in Korea (Cetzine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cetzine. The MFDS reviews the Cetzine KDMF as part of the drug registration process and uses the information provided in the Cetzine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cetzine 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 Cetzine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cetzine suppliers with KDMF on PharmaCompass.
A Cetzine CEP of the European Pharmacopoeia monograph is often referred to as a Cetzine Certificate of Suitability (COS). The purpose of a Cetzine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cetzine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cetzine to their clients by showing that a Cetzine CEP has been issued for it. The manufacturer submits a Cetzine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cetzine CEP holder for the record. Additionally, the data presented in the Cetzine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cetzine DMF.
A Cetzine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cetzine 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 Cetzine suppliers with CEP (COS) on PharmaCompass.
A Cetzine written confirmation (Cetzine WC) is an official document issued by a regulatory agency to a Cetzine manufacturer, verifying that the manufacturing facility of a Cetzine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cetzine APIs or Cetzine finished pharmaceutical products to another nation, regulatory agencies frequently require a Cetzine WC (written confirmation) as part of the regulatory process.
click here to find a list of Cetzine 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 Cetzine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cetzine 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 Cetzine 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 Cetzine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cetzine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cetzine suppliers with NDC on PharmaCompass.
Cetzine 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 Cetzine 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 Cetzine GMP manufacturer or Cetzine GMP API supplier for your needs.
A Cetzine CoA (Certificate of Analysis) is a formal document that attests to Cetzine's compliance with Cetzine specifications and serves as a tool for batch-level quality control.
Cetzine CoA mostly includes findings from lab analyses of a specific batch. For each Cetzine 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.
Cetzine may be tested according to a variety of international standards, such as European Pharmacopoeia (Cetzine EP), Cetzine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cetzine USP).
