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