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