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PharmaCompass offers a list of Phenylalanine 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 Phenylalanine manufacturer or Phenylalanine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Phenylalanine manufacturer or Phenylalanine supplier.
PharmaCompass also assists you with knowing the Phenylalanine API Price utilized in the formulation of products. Phenylalanine API Price is not always fixed or binding as the Phenylalanine Price is obtained through a variety of data sources. The Phenylalanine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A AM20060774 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AM20060774, including repackagers and relabelers. The FDA regulates AM20060774 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AM20060774 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 AM20060774 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A AM20060774 supplier is an individual or a company that provides AM20060774 active pharmaceutical ingredient (API) or AM20060774 finished formulations upon request. The AM20060774 suppliers may include AM20060774 API manufacturers, exporters, distributors and traders.
click here to find a list of AM20060774 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A AM20060774 DMF (Drug Master File) is a document detailing the whole manufacturing process of AM20060774 active pharmaceutical ingredient (API) in detail. Different forms of AM20060774 DMFs exist exist since differing nations have different regulations, such as AM20060774 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A AM20060774 DMF submitted to regulatory agencies in the US is known as a USDMF. AM20060774 USDMF includes data on AM20060774's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AM20060774 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The AM20060774 Drug Master File in Japan (AM20060774 JDMF) empowers AM20060774 API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the AM20060774 JDMF during the approval evaluation for pharmaceutical products. At the time of AM20060774 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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A AM20060774 CEP of the European Pharmacopoeia monograph is often referred to as a AM20060774 Certificate of Suitability (COS). The purpose of a AM20060774 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of AM20060774 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of AM20060774 to their clients by showing that a AM20060774 CEP has been issued for it. The manufacturer submits a AM20060774 CEP (COS) as part of the market authorization procedure, and it takes on the role of a AM20060774 CEP holder for the record. Additionally, the data presented in the AM20060774 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the AM20060774 DMF.
A AM20060774 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. AM20060774 CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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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 AM20060774 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for AM20060774 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 AM20060774 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 AM20060774 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a AM20060774 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of AM20060774 suppliers with NDC on PharmaCompass.
AM20060774 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 AM20060774 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 AM20060774 GMP manufacturer or AM20060774 GMP API supplier for your needs.
A AM20060774 CoA (Certificate of Analysis) is a formal document that attests to AM20060774's compliance with AM20060774 specifications and serves as a tool for batch-level quality control.
AM20060774 CoA mostly includes findings from lab analyses of a specific batch. For each AM20060774 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.
AM20060774 may be tested according to a variety of international standards, such as European Pharmacopoeia (AM20060774 EP), AM20060774 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (AM20060774 USP).
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