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PharmaCompass offers a list of Paroxetine Hydrochloride 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 Paroxetine Hydrochloride manufacturer or Paroxetine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Paroxetine Hydrochloride manufacturer or Paroxetine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Paroxetine Hydrochloride API Price utilized in the formulation of products. Paroxetine Hydrochloride API Price is not always fixed or binding as the Paroxetine Hydrochloride Price is obtained through a variety of data sources. The Paroxetine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Paroxetine HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Paroxetine HCl, including repackagers and relabelers. The FDA regulates Paroxetine HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Paroxetine 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 Paroxetine HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Paroxetine HCl supplier is an individual or a company that provides Paroxetine HCl active pharmaceutical ingredient (API) or Paroxetine HCl finished formulations upon request. The Paroxetine HCl suppliers may include Paroxetine HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Paroxetine HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Paroxetine HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Paroxetine HCl active pharmaceutical ingredient (API) in detail. Different forms of Paroxetine HCl DMFs exist exist since differing nations have different regulations, such as Paroxetine HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Paroxetine HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Paroxetine HCl USDMF includes data on Paroxetine HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Paroxetine HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Paroxetine HCl 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 Paroxetine HCl Drug Master File in Japan (Paroxetine HCl JDMF) empowers Paroxetine 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 Paroxetine HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Paroxetine 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 Paroxetine HCl 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 Paroxetine HCl Drug Master File in Korea (Paroxetine HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Paroxetine HCl. The MFDS reviews the Paroxetine HCl KDMF as part of the drug registration process and uses the information provided in the Paroxetine HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Paroxetine HCl 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 Paroxetine HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Paroxetine HCl suppliers with KDMF on PharmaCompass.
A Paroxetine HCl CEP of the European Pharmacopoeia monograph is often referred to as a Paroxetine HCl Certificate of Suitability (COS). The purpose of a Paroxetine HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Paroxetine HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Paroxetine HCl to their clients by showing that a Paroxetine HCl CEP has been issued for it. The manufacturer submits a Paroxetine HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Paroxetine HCl CEP holder for the record. Additionally, the data presented in the Paroxetine HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Paroxetine HCl DMF.
A Paroxetine HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Paroxetine 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 Paroxetine HCl suppliers with CEP (COS) on PharmaCompass.
A Paroxetine HCl written confirmation (Paroxetine HCl WC) is an official document issued by a regulatory agency to a Paroxetine HCl manufacturer, verifying that the manufacturing facility of a Paroxetine HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Paroxetine HCl APIs or Paroxetine HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Paroxetine HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Paroxetine 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 Paroxetine HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Paroxetine 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 Paroxetine 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 Paroxetine HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Paroxetine HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Paroxetine HCl suppliers with NDC on PharmaCompass.
Paroxetine 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 Paroxetine 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 Paroxetine HCl GMP manufacturer or Paroxetine HCl GMP API supplier for your needs.
A Paroxetine HCl CoA (Certificate of Analysis) is a formal document that attests to Paroxetine HCl's compliance with Paroxetine HCl specifications and serves as a tool for batch-level quality control.
Paroxetine HCl CoA mostly includes findings from lab analyses of a specific batch. For each Paroxetine 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.
Paroxetine HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Paroxetine HCl EP), Paroxetine HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Paroxetine HCl USP).
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