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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]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
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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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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A AMINO ACIDS manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AMINO ACIDS, including repackagers and relabelers. The FDA regulates AMINO ACIDS manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AMINO ACIDS API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A AMINO ACIDS supplier is an individual or a company that provides AMINO ACIDS active pharmaceutical ingredient (API) or AMINO ACIDS finished formulations upon request. The AMINO ACIDS suppliers may include AMINO ACIDS API manufacturers, exporters, distributors and traders.
click here to find a list of AMINO ACIDS suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A AMINO ACIDS DMF (Drug Master File) is a document detailing the whole manufacturing process of AMINO ACIDS active pharmaceutical ingredient (API) in detail. Different forms of AMINO ACIDS DMFs exist exist since differing nations have different regulations, such as AMINO ACIDS USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A AMINO ACIDS DMF submitted to regulatory agencies in the US is known as a USDMF. AMINO ACIDS USDMF includes data on AMINO ACIDS's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AMINO ACIDS USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of AMINO ACIDS suppliers with USDMF on PharmaCompass.
A AMINO ACIDS CEP of the European Pharmacopoeia monograph is often referred to as a AMINO ACIDS Certificate of Suitability (COS). The purpose of a AMINO ACIDS CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of AMINO ACIDS EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of AMINO ACIDS to their clients by showing that a AMINO ACIDS CEP has been issued for it. The manufacturer submits a AMINO ACIDS CEP (COS) as part of the market authorization procedure, and it takes on the role of a AMINO ACIDS CEP holder for the record. Additionally, the data presented in the AMINO ACIDS CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the AMINO ACIDS DMF.
A AMINO ACIDS CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. AMINO ACIDS 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 ACIDS 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 ACIDS as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for AMINO ACIDS 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 ACIDS 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 ACIDS and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a AMINO ACIDS NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of AMINO ACIDS suppliers with NDC on PharmaCompass.
AMINO ACIDS 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 ACIDS 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 ACIDS GMP manufacturer or AMINO ACIDS GMP API supplier for your needs.
A AMINO ACIDS CoA (Certificate of Analysis) is a formal document that attests to AMINO ACIDS's compliance with AMINO ACIDS specifications and serves as a tool for batch-level quality control.
AMINO ACIDS CoA mostly includes findings from lab analyses of a specific batch. For each AMINO ACIDS 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 ACIDS may be tested according to a variety of international standards, such as European Pharmacopoeia (AMINO ACIDS EP), AMINO ACIDS JP (Japanese Pharmacopeia) and the US Pharmacopoeia (AMINO ACIDS USP).
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