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A Noscapine HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Noscapine HCl, including repackagers and relabelers. The FDA regulates Noscapine HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Noscapine HCl 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 Noscapine HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Noscapine HCl supplier is an individual or a company that provides Noscapine HCl active pharmaceutical ingredient (API) or Noscapine HCl finished formulations upon request. The Noscapine HCl suppliers may include Noscapine HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Noscapine HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Noscapine HCl Drug Master File in Japan (Noscapine HCl JDMF) empowers Noscapine HCl 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 Noscapine HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Noscapine HCl 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 Noscapine HCl suppliers with JDMF on PharmaCompass.
A Noscapine HCl CEP of the European Pharmacopoeia monograph is often referred to as a Noscapine HCl Certificate of Suitability (COS). The purpose of a Noscapine HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Noscapine HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Noscapine HCl to their clients by showing that a Noscapine HCl CEP has been issued for it. The manufacturer submits a Noscapine HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Noscapine HCl CEP holder for the record. Additionally, the data presented in the Noscapine HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Noscapine HCl DMF.
A Noscapine HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Noscapine HCl 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 Noscapine HCl suppliers with CEP (COS) on PharmaCompass.
A Noscapine HCl written confirmation (Noscapine HCl WC) is an official document issued by a regulatory agency to a Noscapine HCl manufacturer, verifying that the manufacturing facility of a Noscapine HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Noscapine HCl APIs or Noscapine HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Noscapine HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Noscapine HCl 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 Noscapine HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Noscapine HCl 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 Noscapine HCl 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 Noscapine HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Noscapine HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Noscapine HCl suppliers with NDC on PharmaCompass.
Noscapine HCl 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 Noscapine HCl 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 Noscapine HCl GMP manufacturer or Noscapine HCl GMP API supplier for your needs.
A Noscapine HCl CoA (Certificate of Analysis) is a formal document that attests to Noscapine HCl's compliance with Noscapine HCl specifications and serves as a tool for batch-level quality control.
Noscapine HCl CoA mostly includes findings from lab analyses of a specific batch. For each Noscapine HCl 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.
Noscapine HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Noscapine HCl EP), Noscapine HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Noscapine HCl USP).
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