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Looking for 61869-08-7 / Paroxetine Hydrochloride API manufacturers, exporters & distributors?

Paroxetine Hydrochloride manufacturers, exporters & distributors 1

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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.

API | Excipient name

Paroxetine Hydrochloride

Synonyms

61869-08-7, Paxil, Frosinor, Paxil cr, Casbol, Motivan

Cas Number

61869-08-7

Unique Ingredient Identifier (UNII)

32Q7TW8BX7

About Paroxetine Hydrochloride

A serotonin uptake inhibitor that is effective in the treatment of depression.

Paroxetine Hydrochloride Manufacturers

A Paroxetine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Paroxetine Hydrochloride, including repackagers and relabelers. The FDA regulates Paroxetine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Paroxetine 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 Paroxetine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Paroxetine Hydrochloride Suppliers

A Paroxetine Hydrochloride supplier is an individual or a company that provides Paroxetine Hydrochloride active pharmaceutical ingredient (API) or Paroxetine Hydrochloride finished formulations upon request. The Paroxetine Hydrochloride suppliers may include Paroxetine Hydrochloride API manufacturers, exporters, distributors and traders.

click here to find a list of Paroxetine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Paroxetine Hydrochloride USDMF

A Paroxetine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Paroxetine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Paroxetine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Paroxetine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Paroxetine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Paroxetine Hydrochloride USDMF includes data on Paroxetine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Paroxetine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Paroxetine Hydrochloride suppliers with USDMF on PharmaCompass.

Paroxetine Hydrochloride JDMF

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 Drug Master File in Japan (Paroxetine Hydrochloride JDMF) empowers Paroxetine 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 Paroxetine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Paroxetine 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 Paroxetine Hydrochloride suppliers with JDMF on PharmaCompass.

Paroxetine Hydrochloride KDMF

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 Drug Master File in Korea (Paroxetine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Paroxetine Hydrochloride. The MFDS reviews the Paroxetine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Paroxetine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.

After submitting a Paroxetine Hydrochloride 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 API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Paroxetine Hydrochloride suppliers with KDMF on PharmaCompass.

Paroxetine Hydrochloride CEP

A Paroxetine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Paroxetine Hydrochloride Certificate of Suitability (COS). The purpose of a Paroxetine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Paroxetine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Paroxetine Hydrochloride to their clients by showing that a Paroxetine Hydrochloride CEP has been issued for it. The manufacturer submits a Paroxetine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Paroxetine Hydrochloride CEP holder for the record. Additionally, the data presented in the Paroxetine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Paroxetine Hydrochloride DMF.

A Paroxetine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Paroxetine 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 Paroxetine Hydrochloride suppliers with CEP (COS) on PharmaCompass.

Paroxetine Hydrochloride WC

A Paroxetine Hydrochloride written confirmation (Paroxetine Hydrochloride WC) is an official document issued by a regulatory agency to a Paroxetine Hydrochloride manufacturer, verifying that the manufacturing facility of a Paroxetine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Paroxetine Hydrochloride APIs or Paroxetine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Paroxetine Hydrochloride WC (written confirmation) as part of the regulatory process.

click here to find a list of Paroxetine Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

Paroxetine Hydrochloride NDC

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 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Paroxetine Hydrochloride API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Paroxetine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Paroxetine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Paroxetine Hydrochloride suppliers with NDC on PharmaCompass.

Paroxetine Hydrochloride GMP

Paroxetine 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 Paroxetine 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 Paroxetine Hydrochloride GMP manufacturer or Paroxetine Hydrochloride GMP API supplier for your needs.

Paroxetine Hydrochloride CoA

A Paroxetine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Paroxetine Hydrochloride's compliance with Paroxetine Hydrochloride specifications and serves as a tool for batch-level quality control.

Paroxetine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Paroxetine 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.

Paroxetine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Paroxetine Hydrochloride EP), Paroxetine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Paroxetine Hydrochloride USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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