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