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API SUPPLIERS
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
With Virupaksha, you get a quality product with on-time delivery.
JDMF 
EU-WC
NDC
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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.
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
AMI Lifesciences is Driven by Chemistry. Powered by People.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
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ABOUT THIS PAGE
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PharmaCompass offers a list of Bilastine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Bilastine manufacturer or Bilastine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bilastine manufacturer or Bilastine supplier.
A Ilaxten manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ilaxten, including repackagers and relabelers. The FDA regulates Ilaxten manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ilaxten 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 Ilaxten manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ilaxten supplier is an individual or a company that provides Ilaxten active pharmaceutical ingredient (API) or Ilaxten finished formulations upon request. The Ilaxten suppliers may include Ilaxten API manufacturers, exporters, distributors and traders.
click here to find a list of Ilaxten suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Ilaxten DMF (Drug Master File) is a document detailing the whole manufacturing process of Ilaxten active pharmaceutical ingredient (API) in detail. Different forms of Ilaxten DMFs exist exist since differing nations have different regulations, such as Ilaxten USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ilaxten DMF submitted to regulatory agencies in the US is known as a USDMF. Ilaxten USDMF includes data on Ilaxten's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ilaxten USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ilaxten 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 Ilaxten Drug Master File in Japan (Ilaxten JDMF) empowers Ilaxten 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 Ilaxten JDMF during the approval evaluation for pharmaceutical products. At the time of Ilaxten 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 Ilaxten suppliers with JDMF on PharmaCompass.
A Ilaxten written confirmation (Ilaxten WC) is an official document issued by a regulatory agency to a Ilaxten manufacturer, verifying that the manufacturing facility of a Ilaxten active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ilaxten APIs or Ilaxten finished pharmaceutical products to another nation, regulatory agencies frequently require a Ilaxten WC (written confirmation) as part of the regulatory process.
click here to find a list of Ilaxten 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 Ilaxten as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ilaxten 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 Ilaxten 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 Ilaxten and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ilaxten NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ilaxten suppliers with NDC on PharmaCompass.
Ilaxten 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 Ilaxten GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ilaxten GMP manufacturer or Ilaxten GMP API supplier for your needs.
A Ilaxten CoA (Certificate of Analysis) is a formal document that attests to Ilaxten's compliance with Ilaxten specifications and serves as a tool for batch-level quality control.
Ilaxten CoA mostly includes findings from lab analyses of a specific batch. For each Ilaxten 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.
Ilaxten may be tested according to a variety of international standards, such as European Pharmacopoeia (Ilaxten EP), Ilaxten JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ilaxten USP).
