Synopsis
Synopsis
0
JDMF
0
EU WC
0
KDMF
0
VMF
0
Canada
0
Australia
0
US Patents
0
US Exclusivities
0
Health Canada Patents
Annual Reports
NA
0
API
0
FDF
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
1. Acid, Essential Amino
2. Acids, Essential Amino
3. Amino Acid, Essential
4. Amino Acids, Essential
5. Essential Amino Acid
1. Amino Acids, Essential
2. Amino Acids, Essential-
3. E500000000
Molecular Weight | 1163.4 g/mol |
---|---|
Molecular Formula | C52H94N10O17S |
Hydrogen Bond Donor Count | 19 |
Hydrogen Bond Acceptor Count | 27 |
Rotatable Bond Count | 25 |
Exact Mass | 1162.65191274 g/mol |
Monoisotopic Mass | 1162.65191274 g/mol |
Topological Polar Surface Area | 594 Ų |
Heavy Atom Count | 80 |
Formal Charge | 0 |
Complexity | 988 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 10 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 8 |
RLD : No
TE Code :
AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE
Brand Name : AMINOSYN 3.5% M IN PLASTIC CONTAINER
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 3.5%;21MG/100ML;40MG/100ML;128MG/100ML;234MG/100ML
Approval Date : 1984-05-15
Application Number : 18804
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 4.25%;20GM/100ML
Approval Date : 1988-09-09
Application Number : 19713
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : NEPHRAMINE 5.4%
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 5.4% (5.4GM/100ML)
Approval Date : 1982-01-01
Application Number : 17766
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 15% (15GM/100ML)
Approval Date : 1996-08-30
Application Number : 20512
RX/OTC/DISCN : RX
RLD : No
TE Code :
RLD : Yes
TE Code :
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE
Brand Name : CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 5%;33MG/100ML;20GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML
Approval Date : 1997-03-26
Application Number : 20678
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 4.25%;20GM/100ML
Approval Date : 1997-09-29
Application Number : 20734
RX/OTC/DISCN : RX
RLD : No
TE Code :
RLD : Yes
TE Code :
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL
Brand Name : PERIKABIVEN IN PLASTIC CONTAINER
Dosage Form : EMULSION;INTRAVENOUS
Dosage Strength : 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML)
Approval Date : 2014-08-25
Application Number : 200656
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : NOVAMINE 15%
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 15% (75GM/500ML)
Approval Date : 1986-11-28
Application Number : 17957
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 4.25%;25GM/100ML
Approval Date : 1988-11-01
Application Number : 19681
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
Brand Name : AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 4.25%;36.8MG/100ML;20GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML
Approval Date : 1988-11-07
Application Number : 19683
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Regulatory Info :
Registration Country : Italy
Brand Name : Nutrineal Pd4
Dosage Form : Amino Acids 1,1% 2.000Ml 1 Units Parenteral Use
Dosage Strength : 1 bag 2,000 ml 1,1%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Amino Acids S
Dosage Form :
Dosage Strength : 1 Bottle Ev 500 Ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Strong Solamin
Dosage Form :
Dosage Strength : 1 Bottle Ev 500 Ml 7.5%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Vamin 18 g N/L Elektrolyttfri
Dosage Form : Infusion fluid, resolution
Dosage Strength : (not entered)
Packaging : The infusion bottle of glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Italy
Brand Name : Amino Acids Branched Chain
Dosage Form :
Dosage Strength : 1 Bottle 250 Ml 4%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Amino Acids Essential And Nonessential
Dosage Form :
Dosage Strength : 1 500 Ml Bottle
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Selective Amino Acids
Dosage Form :
Dosage Strength : 1 Bottle 250 Ml 8%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Isogrow 6%
Dosage Form :
Dosage Strength : 1 Bottle 500 Ml 6%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Italy
Brand Name : Isopuramin 3%
Dosage Form :
Dosage Strength : 1 Bottle Ev 250 Ml 3%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Italy
Brand Name : Isoren 5,4%
Dosage Form :
Dosage Strength : 1 Bottle 500 Ml 5.4%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Minamino
Dosage Form : SYR
Dosage Strength : 100mg/5ml
Packaging : 200X1mg/5ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Minamino
Dosage Form : SYR
Dosage Strength : 100mg/5ml
Packaging : 500X1mg/5ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Aminosteril N-Hepa 8%
Dosage Form : INF
Dosage Strength : 80g
Packaging : 500X1g
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : ITN 1502S
Dosage Form : INF
Dosage Strength : 1ZZZ
Packaging : 1X1ZZZ
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : ITN 1005 N
Dosage Form : INF
Dosage Strength : 1ZZZ
Packaging : 1X1ZZZ
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : ITN 8001 A
Dosage Form : INF
Dosage Strength : 1ZZZ
Packaging : 1X1ZZZ
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : ITN 8006 A
Dosage Form : INF
Dosage Strength : 1ZZZ
Packaging : 1X1ZZZ
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : ITN 5001A
Dosage Form : INF
Dosage Strength : 1ZZZ
Packaging : 1X1ZZZ
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : ITN 5001 X A
Dosage Form : INF
Dosage Strength : 1ZZZ
Packaging : 1X1ZZZ
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Kabiven
Dosage Form : INF
Dosage Strength : 68g
Packaging : 2053X2g
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : South Korea
Brand Name : Supportamin Infusion
Dosage Form : Infusion
Dosage Strength : 8.5%
Packaging : Bag (100mL, 250mL)
Approval Date :
Application Number :
Regulatory Info :
Registration Country : South Korea
Packaging : Bag (100mL, 250mL)
Regulatory Info :
Dosage : Infusion
Dosage Strength : 8.5%
Brand Name : Supportamin Infusion
Approval Date :
Application Number :
Registration Country : South Korea
Regulatory Info :
Registration Country : India
Ferrous Ascorbate; Folic Acid; Vitamin B6; Zinc; Mecobalamin; AMINO ACIDS
Brand Name : Nicefer
Dosage Form : Tablet
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Ferrous Ascorbate; Folic Acid; Vitamin B6; Zinc; Mecobalamin; AMINO ACIDS
Dosage : Tablet
Dosage Strength :
Brand Name : Nicefer
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : Greece
Brand Name : TONOTIL ®
Dosage Form :
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Greece
Packaging :
Regulatory Info :
Dosage :
Dosage Strength :
Brand Name : TONOTIL ®
Approval Date :
Application Number :
Registration Country : Greece
DRUG PRODUCT COMPOSITIONS
Global Sales Information
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
16
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 TROPHAMINE 10% manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TROPHAMINE 10%, including repackagers and relabelers. The FDA regulates TROPHAMINE 10% manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TROPHAMINE 10% 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 TROPHAMINE 10% manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A TROPHAMINE 10% supplier is an individual or a company that provides TROPHAMINE 10% active pharmaceutical ingredient (API) or TROPHAMINE 10% finished formulations upon request. The TROPHAMINE 10% suppliers may include TROPHAMINE 10% API manufacturers, exporters, distributors and traders.
click here to find a list of TROPHAMINE 10% suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A TROPHAMINE 10% DMF (Drug Master File) is a document detailing the whole manufacturing process of TROPHAMINE 10% active pharmaceutical ingredient (API) in detail. Different forms of TROPHAMINE 10% DMFs exist exist since differing nations have different regulations, such as TROPHAMINE 10% USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A TROPHAMINE 10% DMF submitted to regulatory agencies in the US is known as a USDMF. TROPHAMINE 10% USDMF includes data on TROPHAMINE 10%'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The TROPHAMINE 10% USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of TROPHAMINE 10% suppliers with USDMF on PharmaCompass.
A TROPHAMINE 10% CEP of the European Pharmacopoeia monograph is often referred to as a TROPHAMINE 10% Certificate of Suitability (COS). The purpose of a TROPHAMINE 10% CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of TROPHAMINE 10% EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of TROPHAMINE 10% to their clients by showing that a TROPHAMINE 10% CEP has been issued for it. The manufacturer submits a TROPHAMINE 10% CEP (COS) as part of the market authorization procedure, and it takes on the role of a TROPHAMINE 10% CEP holder for the record. Additionally, the data presented in the TROPHAMINE 10% CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the TROPHAMINE 10% DMF.
A TROPHAMINE 10% CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. TROPHAMINE 10% 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 TROPHAMINE 10% 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 TROPHAMINE 10% as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for TROPHAMINE 10% 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 TROPHAMINE 10% 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 TROPHAMINE 10% and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a TROPHAMINE 10% NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of TROPHAMINE 10% suppliers with NDC on PharmaCompass.
TROPHAMINE 10% 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 TROPHAMINE 10% 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 TROPHAMINE 10% GMP manufacturer or TROPHAMINE 10% GMP API supplier for your needs.
A TROPHAMINE 10% CoA (Certificate of Analysis) is a formal document that attests to TROPHAMINE 10%'s compliance with TROPHAMINE 10% specifications and serves as a tool for batch-level quality control.
TROPHAMINE 10% CoA mostly includes findings from lab analyses of a specific batch. For each TROPHAMINE 10% 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.
TROPHAMINE 10% may be tested according to a variety of international standards, such as European Pharmacopoeia (TROPHAMINE 10% EP), TROPHAMINE 10% JP (Japanese Pharmacopeia) and the US Pharmacopoeia (TROPHAMINE 10% USP).