Synopsis
0
JDMF
0
EU WC
0
KDMF
0
VMF
0
Canada
0
Australia
DRUG PRODUCT COMPOSITIONS0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
API
0
FDF
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - INJECTABLE;INJECTION - 10% (10GM/100...DOSAGE - INJECTABLE;INJECTION - 10% (10GM/100ML)
USFDA APPLICATION NUMBER - 19018
DOSAGE - INJECTABLE;INJECTION - 6% (6GM/100ML...DOSAGE - INJECTABLE;INJECTION - 6% (6GM/100ML)
USFDA APPLICATION NUMBER - 19018
DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100...DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML)
USFDA APPLICATION NUMBER - 200656
DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100...DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML)
USFDA APPLICATION NUMBER - 200656
DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100...DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML)
USFDA APPLICATION NUMBER - 200656
DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100...DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML)
USFDA APPLICATION NUMBER - 200656
DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100...DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML)
USFDA APPLICATION NUMBER - 200656
DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100...DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML)
USFDA APPLICATION NUMBER - 200656
DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100...DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML)
USFDA APPLICATION NUMBER - 200656
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
83
PharmaCompass offers a list of Amino Acids Mixture 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 Amino Acids Mixture manufacturer or Amino Acids Mixture supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Amino Acids Mixture manufacturer or Amino Acids Mixture supplier.
PharmaCompass also assists you with knowing the Amino Acids Mixture API Price utilized in the formulation of products. Amino Acids Mixture API Price is not always fixed or binding as the Amino Acids Mixture Price is obtained through a variety of data sources. The Amino Acids Mixture Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A AMINO ACID manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AMINO ACID, including repackagers and relabelers. The FDA regulates AMINO ACID manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AMINO ACID 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 AMINO ACID manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A AMINO ACID supplier is an individual or a company that provides AMINO ACID active pharmaceutical ingredient (API) or AMINO ACID finished formulations upon request. The AMINO ACID suppliers may include AMINO ACID API manufacturers, exporters, distributors and traders.
click here to find a list of AMINO ACID suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A AMINO ACID DMF (Drug Master File) is a document detailing the whole manufacturing process of AMINO ACID active pharmaceutical ingredient (API) in detail. Different forms of AMINO ACID DMFs exist exist since differing nations have different regulations, such as AMINO ACID USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A AMINO ACID DMF submitted to regulatory agencies in the US is known as a USDMF. AMINO ACID USDMF includes data on AMINO ACID's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AMINO ACID USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of AMINO ACID suppliers with USDMF on PharmaCompass.
A AMINO ACID CEP of the European Pharmacopoeia monograph is often referred to as a AMINO ACID Certificate of Suitability (COS). The purpose of a AMINO ACID CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of AMINO ACID EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of AMINO ACID to their clients by showing that a AMINO ACID CEP has been issued for it. The manufacturer submits a AMINO ACID CEP (COS) as part of the market authorization procedure, and it takes on the role of a AMINO ACID CEP holder for the record. Additionally, the data presented in the AMINO ACID CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the AMINO ACID DMF.
A AMINO ACID CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. AMINO ACID 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 AMINO ACID 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 AMINO ACID as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for AMINO ACID 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 AMINO ACID 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 AMINO ACID and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a AMINO ACID NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of AMINO ACID suppliers with NDC on PharmaCompass.
AMINO ACID 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 AMINO ACID 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 AMINO ACID GMP manufacturer or AMINO ACID GMP API supplier for your needs.
A AMINO ACID CoA (Certificate of Analysis) is a formal document that attests to AMINO ACID's compliance with AMINO ACID specifications and serves as a tool for batch-level quality control.
AMINO ACID CoA mostly includes findings from lab analyses of a specific batch. For each AMINO ACID 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.
AMINO ACID may be tested according to a variety of international standards, such as European Pharmacopoeia (AMINO ACID EP), AMINO ACID JP (Japanese Pharmacopeia) and the US Pharmacopoeia (AMINO ACID USP).
