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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
CAS Number : 5267-64-1
End Use API : Amino Acids Mixture
About The Company : PMC Isochem is a CDMO company acquired by PMC International in 2017. It manufactures cGMP intermediates, active pharmaceutical ingredients and functional excipi...
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]South Africa
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Dossiers
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
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Regulatory FDF Prices
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
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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 FREAMINE III 8.5% manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of FREAMINE III 8.5%, including repackagers and relabelers. The FDA regulates FREAMINE III 8.5% manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. FREAMINE III 8.5% 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 FREAMINE III 8.5% manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A FREAMINE III 8.5% supplier is an individual or a company that provides FREAMINE III 8.5% active pharmaceutical ingredient (API) or FREAMINE III 8.5% finished formulations upon request. The FREAMINE III 8.5% suppliers may include FREAMINE III 8.5% API manufacturers, exporters, distributors and traders.
click here to find a list of FREAMINE III 8.5% suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A FREAMINE III 8.5% DMF (Drug Master File) is a document detailing the whole manufacturing process of FREAMINE III 8.5% active pharmaceutical ingredient (API) in detail. Different forms of FREAMINE III 8.5% DMFs exist exist since differing nations have different regulations, such as FREAMINE III 8.5% USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A FREAMINE III 8.5% DMF submitted to regulatory agencies in the US is known as a USDMF. FREAMINE III 8.5% USDMF includes data on FREAMINE III 8.5%'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The FREAMINE III 8.5% USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of FREAMINE III 8.5% suppliers with USDMF on PharmaCompass.
A FREAMINE III 8.5% CEP of the European Pharmacopoeia monograph is often referred to as a FREAMINE III 8.5% Certificate of Suitability (COS). The purpose of a FREAMINE III 8.5% CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of FREAMINE III 8.5% EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of FREAMINE III 8.5% to their clients by showing that a FREAMINE III 8.5% CEP has been issued for it. The manufacturer submits a FREAMINE III 8.5% CEP (COS) as part of the market authorization procedure, and it takes on the role of a FREAMINE III 8.5% CEP holder for the record. Additionally, the data presented in the FREAMINE III 8.5% CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the FREAMINE III 8.5% DMF.
A FREAMINE III 8.5% CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. FREAMINE III 8.5% 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 FREAMINE III 8.5% 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 FREAMINE III 8.5% as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for FREAMINE III 8.5% 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 FREAMINE III 8.5% 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 FREAMINE III 8.5% and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a FREAMINE III 8.5% NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of FREAMINE III 8.5% suppliers with NDC on PharmaCompass.
FREAMINE III 8.5% 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 FREAMINE III 8.5% 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 FREAMINE III 8.5% GMP manufacturer or FREAMINE III 8.5% GMP API supplier for your needs.
A FREAMINE III 8.5% CoA (Certificate of Analysis) is a formal document that attests to FREAMINE III 8.5%'s compliance with FREAMINE III 8.5% specifications and serves as a tool for batch-level quality control.
FREAMINE III 8.5% CoA mostly includes findings from lab analyses of a specific batch. For each FREAMINE III 8.5% 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.
FREAMINE III 8.5% may be tested according to a variety of international standards, such as European Pharmacopoeia (FREAMINE III 8.5% EP), FREAMINE III 8.5% JP (Japanese Pharmacopeia) and the US Pharmacopoeia (FREAMINE III 8.5% USP).
