API Suppliers
US DMFs Filed
CEP/COS Certifications
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EU WC
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Listed Suppliers
USA (Orange Book)
Europe
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U.S. Medicaid
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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 Oprea1_120838 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oprea1_120838, including repackagers and relabelers. The FDA regulates Oprea1_120838 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oprea1_120838 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 Oprea1_120838 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oprea1_120838 supplier is an individual or a company that provides Oprea1_120838 active pharmaceutical ingredient (API) or Oprea1_120838 finished formulations upon request. The Oprea1_120838 suppliers may include Oprea1_120838 API manufacturers, exporters, distributors and traders.
click here to find a list of Oprea1_120838 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oprea1_120838 DMF (Drug Master File) is a document detailing the whole manufacturing process of Oprea1_120838 active pharmaceutical ingredient (API) in detail. Different forms of Oprea1_120838 DMFs exist exist since differing nations have different regulations, such as Oprea1_120838 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oprea1_120838 DMF submitted to regulatory agencies in the US is known as a USDMF. Oprea1_120838 USDMF includes data on Oprea1_120838's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oprea1_120838 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Oprea1_120838 Drug Master File in Korea (Oprea1_120838 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Oprea1_120838. The MFDS reviews the Oprea1_120838 KDMF as part of the drug registration process and uses the information provided in the Oprea1_120838 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Oprea1_120838 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 Oprea1_120838 API can apply through the Korea Drug Master File (KDMF).
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A Oprea1_120838 CEP of the European Pharmacopoeia monograph is often referred to as a Oprea1_120838 Certificate of Suitability (COS). The purpose of a Oprea1_120838 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Oprea1_120838 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Oprea1_120838 to their clients by showing that a Oprea1_120838 CEP has been issued for it. The manufacturer submits a Oprea1_120838 CEP (COS) as part of the market authorization procedure, and it takes on the role of a Oprea1_120838 CEP holder for the record. Additionally, the data presented in the Oprea1_120838 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Oprea1_120838 DMF.
A Oprea1_120838 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Oprea1_120838 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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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 Oprea1_120838 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Oprea1_120838 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 Oprea1_120838 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 Oprea1_120838 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Oprea1_120838 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Oprea1_120838 suppliers with NDC on PharmaCompass.
Oprea1_120838 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 Oprea1_120838 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 Oprea1_120838 GMP manufacturer or Oprea1_120838 GMP API supplier for your needs.
A Oprea1_120838 CoA (Certificate of Analysis) is a formal document that attests to Oprea1_120838's compliance with Oprea1_120838 specifications and serves as a tool for batch-level quality control.
Oprea1_120838 CoA mostly includes findings from lab analyses of a specific batch. For each Oprea1_120838 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.
Oprea1_120838 may be tested according to a variety of international standards, such as European Pharmacopoeia (Oprea1_120838 EP), Oprea1_120838 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Oprea1_120838 USP).