X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
0
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
0
EDQM
USP
0
JP
0
Other Listed Suppliers
0
0
100
PharmaCompass offers a list of Sertaconazole Nitrate 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 Sertaconazole Nitrate manufacturer or Sertaconazole Nitrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sertaconazole Nitrate manufacturer or Sertaconazole Nitrate supplier.
PharmaCompass also assists you with knowing the Sertaconazole Nitrate API Price utilized in the formulation of products. Sertaconazole Nitrate API Price is not always fixed or binding as the Sertaconazole Nitrate Price is obtained through a variety of data sources. The Sertaconazole Nitrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sertaconazole Nitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sertaconazole Nitrate, including repackagers and relabelers. The FDA regulates Sertaconazole Nitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sertaconazole Nitrate 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 Sertaconazole Nitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sertaconazole Nitrate supplier is an individual or a company that provides Sertaconazole Nitrate active pharmaceutical ingredient (API) or Sertaconazole Nitrate finished formulations upon request. The Sertaconazole Nitrate suppliers may include Sertaconazole Nitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Sertaconazole Nitrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sertaconazole Nitrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sertaconazole Nitrate active pharmaceutical ingredient (API) in detail. Different forms of Sertaconazole Nitrate DMFs exist exist since differing nations have different regulations, such as Sertaconazole Nitrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sertaconazole Nitrate DMF submitted to regulatory agencies in the US is known as a USDMF. Sertaconazole Nitrate USDMF includes data on Sertaconazole Nitrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sertaconazole Nitrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sertaconazole Nitrate suppliers with USDMF 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 Sertaconazole Nitrate Drug Master File in Korea (Sertaconazole Nitrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sertaconazole Nitrate. The MFDS reviews the Sertaconazole Nitrate KDMF as part of the drug registration process and uses the information provided in the Sertaconazole Nitrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sertaconazole Nitrate 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 Sertaconazole Nitrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sertaconazole Nitrate suppliers with KDMF on PharmaCompass.
A Sertaconazole Nitrate CEP of the European Pharmacopoeia monograph is often referred to as a Sertaconazole Nitrate Certificate of Suitability (COS). The purpose of a Sertaconazole Nitrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sertaconazole Nitrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sertaconazole Nitrate to their clients by showing that a Sertaconazole Nitrate CEP has been issued for it. The manufacturer submits a Sertaconazole Nitrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sertaconazole Nitrate CEP holder for the record. Additionally, the data presented in the Sertaconazole Nitrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sertaconazole Nitrate DMF.
A Sertaconazole Nitrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sertaconazole Nitrate 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 Sertaconazole Nitrate suppliers with CEP (COS) on PharmaCompass.
A Sertaconazole Nitrate written confirmation (Sertaconazole Nitrate WC) is an official document issued by a regulatory agency to a Sertaconazole Nitrate manufacturer, verifying that the manufacturing facility of a Sertaconazole Nitrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sertaconazole Nitrate APIs or Sertaconazole Nitrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Sertaconazole Nitrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Sertaconazole Nitrate 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 Sertaconazole Nitrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sertaconazole Nitrate 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 Sertaconazole Nitrate 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 Sertaconazole Nitrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sertaconazole Nitrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sertaconazole Nitrate suppliers with NDC on PharmaCompass.
Sertaconazole Nitrate 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 Sertaconazole Nitrate 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 Sertaconazole Nitrate GMP manufacturer or Sertaconazole Nitrate GMP API supplier for your needs.
A Sertaconazole Nitrate CoA (Certificate of Analysis) is a formal document that attests to Sertaconazole Nitrate's compliance with Sertaconazole Nitrate specifications and serves as a tool for batch-level quality control.
Sertaconazole Nitrate CoA mostly includes findings from lab analyses of a specific batch. For each Sertaconazole Nitrate 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.
Sertaconazole Nitrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sertaconazole Nitrate EP), Sertaconazole Nitrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sertaconazole Nitrate USP).
Market Place
