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