X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
95
PharmaCompass offers a list of Sertraline 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 Sertraline Hydrochloride manufacturer or Sertraline Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sertraline Hydrochloride manufacturer or Sertraline Hydrochloride supplier.
PharmaCompass also assists you with knowing the Sertraline Hydrochloride API Price utilized in the formulation of products. Sertraline Hydrochloride API Price is not always fixed or binding as the Sertraline Hydrochloride Price is obtained through a variety of data sources. The Sertraline Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sertraline Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sertraline Hydrochloride, including repackagers and relabelers. The FDA regulates Sertraline Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sertraline 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 Sertraline Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sertraline Hydrochloride supplier is an individual or a company that provides Sertraline Hydrochloride active pharmaceutical ingredient (API) or Sertraline Hydrochloride finished formulations upon request. The Sertraline Hydrochloride suppliers may include Sertraline Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Sertraline Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sertraline Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Sertraline Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Sertraline Hydrochloride DMFs exist exist since differing nations have different regulations, such as Sertraline Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sertraline Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Sertraline Hydrochloride USDMF includes data on Sertraline Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sertraline Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sertraline Hydrochloride 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 Sertraline Hydrochloride Drug Master File in Japan (Sertraline Hydrochloride JDMF) empowers Sertraline 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 Sertraline Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Sertraline 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 Sertraline Hydrochloride 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 Sertraline Hydrochloride Drug Master File in Korea (Sertraline Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sertraline Hydrochloride. The MFDS reviews the Sertraline Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Sertraline Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sertraline 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 Sertraline Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sertraline Hydrochloride suppliers with KDMF on PharmaCompass.
A Sertraline Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Sertraline Hydrochloride Certificate of Suitability (COS). The purpose of a Sertraline Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sertraline Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sertraline Hydrochloride to their clients by showing that a Sertraline Hydrochloride CEP has been issued for it. The manufacturer submits a Sertraline Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sertraline Hydrochloride CEP holder for the record. Additionally, the data presented in the Sertraline Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sertraline Hydrochloride DMF.
A Sertraline Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sertraline 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 Sertraline Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Sertraline Hydrochloride written confirmation (Sertraline Hydrochloride WC) is an official document issued by a regulatory agency to a Sertraline Hydrochloride manufacturer, verifying that the manufacturing facility of a Sertraline Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sertraline Hydrochloride APIs or Sertraline Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Sertraline Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Sertraline 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 Sertraline Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sertraline 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 Sertraline 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 Sertraline Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sertraline Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sertraline Hydrochloride suppliers with NDC on PharmaCompass.
Sertraline 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 Sertraline 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 Sertraline Hydrochloride GMP manufacturer or Sertraline Hydrochloride GMP API supplier for your needs.
A Sertraline Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Sertraline Hydrochloride's compliance with Sertraline Hydrochloride specifications and serves as a tool for batch-level quality control.
Sertraline Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Sertraline 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.
Sertraline Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Sertraline Hydrochloride EP), Sertraline Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sertraline Hydrochloride USP).
Market Place
