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