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13 Feb 2018
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Levocabastine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levocabastine, including repackagers and relabelers. The FDA regulates Levocabastine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levocabastine 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 Levocabastine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levocabastine supplier is an individual or a company that provides Levocabastine active pharmaceutical ingredient (API) or Levocabastine finished formulations upon request. The Levocabastine suppliers may include Levocabastine API manufacturers, exporters, distributors and traders.
click here to find a list of Levocabastine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Levocabastine DMF (Drug Master File) is a document detailing the whole manufacturing process of Levocabastine active pharmaceutical ingredient (API) in detail. Different forms of Levocabastine DMFs exist exist since differing nations have different regulations, such as Levocabastine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Levocabastine DMF submitted to regulatory agencies in the US is known as a USDMF. Levocabastine USDMF includes data on Levocabastine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levocabastine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Levocabastine 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 Levocabastine Drug Master File in Japan (Levocabastine JDMF) empowers Levocabastine 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 Levocabastine JDMF during the approval evaluation for pharmaceutical products. At the time of Levocabastine 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 Levocabastine suppliers with JDMF on PharmaCompass.
A Levocabastine CEP of the European Pharmacopoeia monograph is often referred to as a Levocabastine Certificate of Suitability (COS). The purpose of a Levocabastine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Levocabastine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Levocabastine to their clients by showing that a Levocabastine CEP has been issued for it. The manufacturer submits a Levocabastine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Levocabastine CEP holder for the record. Additionally, the data presented in the Levocabastine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Levocabastine DMF.
A Levocabastine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Levocabastine 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 Levocabastine suppliers with CEP (COS) 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 Levocabastine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Levocabastine 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 Levocabastine 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 Levocabastine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Levocabastine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Levocabastine suppliers with NDC on PharmaCompass.
Levocabastine 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 Levocabastine 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 Levocabastine GMP manufacturer or Levocabastine GMP API supplier for your needs.
A Levocabastine CoA (Certificate of Analysis) is a formal document that attests to Levocabastine's compliance with Levocabastine specifications and serves as a tool for batch-level quality control.
Levocabastine CoA mostly includes findings from lab analyses of a specific batch. For each Levocabastine 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.
Levocabastine may be tested according to a variety of international standards, such as European Pharmacopoeia (Levocabastine EP), Levocabastine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Levocabastine USP).
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