X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
0
Other Suppliers
0
USA (Orange Book)
0
Europe
0
Canada
Australia
South Africa
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
34
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 Phenylalanine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phenylalanine, including repackagers and relabelers. The FDA regulates Phenylalanine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phenylalanine 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 Phenylalanine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Phenylalanine supplier is an individual or a company that provides Phenylalanine active pharmaceutical ingredient (API) or Phenylalanine finished formulations upon request. The Phenylalanine suppliers may include Phenylalanine API manufacturers, exporters, distributors and traders.
click here to find a list of Phenylalanine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Phenylalanine DMF (Drug Master File) is a document detailing the whole manufacturing process of Phenylalanine active pharmaceutical ingredient (API) in detail. Different forms of Phenylalanine DMFs exist exist since differing nations have different regulations, such as Phenylalanine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Phenylalanine DMF submitted to regulatory agencies in the US is known as a USDMF. Phenylalanine USDMF includes data on Phenylalanine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Phenylalanine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Phenylalanine suppliers with USDMF on PharmaCompass.
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 Phenylalanine Drug Master File in Japan (Phenylalanine JDMF) empowers Phenylalanine 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 Phenylalanine JDMF during the approval evaluation for pharmaceutical products. At the time of Phenylalanine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Phenylalanine suppliers with JDMF on PharmaCompass.
A Phenylalanine CEP of the European Pharmacopoeia monograph is often referred to as a Phenylalanine Certificate of Suitability (COS). The purpose of a Phenylalanine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Phenylalanine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Phenylalanine to their clients by showing that a Phenylalanine CEP has been issued for it. The manufacturer submits a Phenylalanine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Phenylalanine CEP holder for the record. Additionally, the data presented in the Phenylalanine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Phenylalanine DMF.
A Phenylalanine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Phenylalanine 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 Phenylalanine 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 Phenylalanine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Phenylalanine 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 Phenylalanine 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 Phenylalanine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Phenylalanine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Phenylalanine suppliers with NDC on PharmaCompass.
Phenylalanine 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 Phenylalanine 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 Phenylalanine GMP manufacturer or Phenylalanine GMP API supplier for your needs.
A Phenylalanine CoA (Certificate of Analysis) is a formal document that attests to Phenylalanine's compliance with Phenylalanine specifications and serves as a tool for batch-level quality control.
Phenylalanine CoA mostly includes findings from lab analyses of a specific batch. For each Phenylalanine 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.
Phenylalanine may be tested according to a variety of international standards, such as European Pharmacopoeia (Phenylalanine EP), Phenylalanine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Phenylalanine USP).
Market Place
