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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]Related Excipient Companies
EUROAPI
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kewpie Corporation
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Bioplus Life Sciences
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ABOUT THIS PAGE
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 LS-1515 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of LS-1515, including repackagers and relabelers. The FDA regulates LS-1515 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. LS-1515 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 LS-1515 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A LS-1515 supplier is an individual or a company that provides LS-1515 active pharmaceutical ingredient (API) or LS-1515 finished formulations upon request. The LS-1515 suppliers may include LS-1515 API manufacturers, exporters, distributors and traders.
click here to find a list of LS-1515 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A LS-1515 DMF (Drug Master File) is a document detailing the whole manufacturing process of LS-1515 active pharmaceutical ingredient (API) in detail. Different forms of LS-1515 DMFs exist exist since differing nations have different regulations, such as LS-1515 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A LS-1515 DMF submitted to regulatory agencies in the US is known as a USDMF. LS-1515 USDMF includes data on LS-1515's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The LS-1515 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of LS-1515 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 LS-1515 Drug Master File in Japan (LS-1515 JDMF) empowers LS-1515 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 LS-1515 JDMF during the approval evaluation for pharmaceutical products. At the time of LS-1515 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 LS-1515 suppliers with JDMF on PharmaCompass.
A LS-1515 CEP of the European Pharmacopoeia monograph is often referred to as a LS-1515 Certificate of Suitability (COS). The purpose of a LS-1515 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of LS-1515 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of LS-1515 to their clients by showing that a LS-1515 CEP has been issued for it. The manufacturer submits a LS-1515 CEP (COS) as part of the market authorization procedure, and it takes on the role of a LS-1515 CEP holder for the record. Additionally, the data presented in the LS-1515 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the LS-1515 DMF.
A LS-1515 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. LS-1515 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 LS-1515 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 LS-1515 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for LS-1515 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 LS-1515 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 LS-1515 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a LS-1515 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of LS-1515 suppliers with NDC on PharmaCompass.
LS-1515 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 LS-1515 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 LS-1515 GMP manufacturer or LS-1515 GMP API supplier for your needs.
A LS-1515 CoA (Certificate of Analysis) is a formal document that attests to LS-1515's compliance with LS-1515 specifications and serves as a tool for batch-level quality control.
LS-1515 CoA mostly includes findings from lab analyses of a specific batch. For each LS-1515 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.
LS-1515 may be tested according to a variety of international standards, such as European Pharmacopoeia (LS-1515 EP), LS-1515 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (LS-1515 USP).
