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