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DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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API SUPPLIERS
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
ASMF, CN 
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
JDMF
EU-WC
NDC
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
EU-WC
NDC
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Emay Pharmaceuticals is a GMP-certified API manufacturing company.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
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USDMF
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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DOSAGE - SOLUTION;ORAL - 2.5MG/5ML
USFDA APPLICATION NUMBER - 209090
DOSAGE - TABLET;ORAL - 5MG **Federal Register...DOSAGE - TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22064
DOSAGE - SOLUTION;ORAL - 2.5MG/5ML **Federal ...DOSAGE - SOLUTION;ORAL - 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22157
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EUROAPI
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ABOUT THIS PAGE
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PharmaCompass offers a list of Levocetirizine 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 Levocetirizine Dihydrochloride manufacturer or Levocetirizine Dihydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Levocetirizine Dihydrochloride manufacturer or Levocetirizine Dihydrochloride supplier.
PharmaCompass also assists you with knowing the Levocetirizine Dihydrochloride API Price utilized in the formulation of products. Levocetirizine Dihydrochloride API Price is not always fixed or binding as the Levocetirizine Dihydrochloride Price is obtained through a variety of data sources. The Levocetirizine Dihydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Xyzal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Xyzal, including repackagers and relabelers. The FDA regulates Xyzal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Xyzal 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 Xyzal manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Xyzal supplier is an individual or a company that provides Xyzal active pharmaceutical ingredient (API) or Xyzal finished formulations upon request. The Xyzal suppliers may include Xyzal API manufacturers, exporters, distributors and traders.
click here to find a list of Xyzal suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Xyzal DMF (Drug Master File) is a document detailing the whole manufacturing process of Xyzal active pharmaceutical ingredient (API) in detail. Different forms of Xyzal DMFs exist exist since differing nations have different regulations, such as Xyzal USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Xyzal DMF submitted to regulatory agencies in the US is known as a USDMF. Xyzal USDMF includes data on Xyzal's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Xyzal USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Xyzal 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 Xyzal Drug Master File in Japan (Xyzal JDMF) empowers Xyzal 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 Xyzal JDMF during the approval evaluation for pharmaceutical products. At the time of Xyzal 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 Xyzal 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 Xyzal Drug Master File in Korea (Xyzal KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Xyzal. The MFDS reviews the Xyzal KDMF as part of the drug registration process and uses the information provided in the Xyzal KDMF to evaluate the safety and efficacy of the drug.
After submitting a Xyzal 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 Xyzal API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Xyzal suppliers with KDMF on PharmaCompass.
A Xyzal CEP of the European Pharmacopoeia monograph is often referred to as a Xyzal Certificate of Suitability (COS). The purpose of a Xyzal CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Xyzal EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Xyzal to their clients by showing that a Xyzal CEP has been issued for it. The manufacturer submits a Xyzal CEP (COS) as part of the market authorization procedure, and it takes on the role of a Xyzal CEP holder for the record. Additionally, the data presented in the Xyzal CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Xyzal DMF.
A Xyzal CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Xyzal 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 Xyzal suppliers with CEP (COS) on PharmaCompass.
A Xyzal written confirmation (Xyzal WC) is an official document issued by a regulatory agency to a Xyzal manufacturer, verifying that the manufacturing facility of a Xyzal active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Xyzal APIs or Xyzal finished pharmaceutical products to another nation, regulatory agencies frequently require a Xyzal WC (written confirmation) as part of the regulatory process.
click here to find a list of Xyzal 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 Xyzal as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Xyzal 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 Xyzal 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 Xyzal and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Xyzal NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Xyzal suppliers with NDC on PharmaCompass.
Xyzal 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 Xyzal 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 Xyzal GMP manufacturer or Xyzal GMP API supplier for your needs.
A Xyzal CoA (Certificate of Analysis) is a formal document that attests to Xyzal's compliance with Xyzal specifications and serves as a tool for batch-level quality control.
Xyzal CoA mostly includes findings from lab analyses of a specific batch. For each Xyzal 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.
Xyzal may be tested according to a variety of international standards, such as European Pharmacopoeia (Xyzal EP), Xyzal JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Xyzal USP).
