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ABOUT THIS PAGE
A Polysorbate API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Polysorbate API, including repackagers and relabelers. The FDA regulates Polysorbate API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Polysorbate API 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 Polysorbate API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Polysorbate API supplier is an individual or a company that provides Polysorbate API active pharmaceutical ingredient (API) or Polysorbate API finished formulations upon request. The Polysorbate API suppliers may include Polysorbate API API manufacturers, exporters, distributors and traders.
click here to find a list of Polysorbate API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Polysorbate API DMF (Drug Master File) is a document detailing the whole manufacturing process of Polysorbate API active pharmaceutical ingredient (API) in detail. Different forms of Polysorbate API DMFs exist exist since differing nations have different regulations, such as Polysorbate API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Polysorbate API DMF submitted to regulatory agencies in the US is known as a USDMF. Polysorbate API USDMF includes data on Polysorbate API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Polysorbate API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Polysorbate API suppliers with USDMF on PharmaCompass.
A Polysorbate API CEP of the European Pharmacopoeia monograph is often referred to as a Polysorbate API Certificate of Suitability (COS). The purpose of a Polysorbate API CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Polysorbate API EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Polysorbate API to their clients by showing that a Polysorbate API CEP has been issued for it. The manufacturer submits a Polysorbate API CEP (COS) as part of the market authorization procedure, and it takes on the role of a Polysorbate API CEP holder for the record. Additionally, the data presented in the Polysorbate API CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Polysorbate API DMF.
A Polysorbate API CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Polysorbate API 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 Polysorbate API suppliers with CEP (COS) on PharmaCompass.
Polysorbate API 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 Polysorbate API 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 Polysorbate API GMP manufacturer or Polysorbate API GMP API supplier for your needs.
A Polysorbate API CoA (Certificate of Analysis) is a formal document that attests to Polysorbate API's compliance with Polysorbate API specifications and serves as a tool for batch-level quality control.
Polysorbate API CoA mostly includes findings from lab analyses of a specific batch. For each Polysorbate API 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.
Polysorbate API may be tested according to a variety of international standards, such as European Pharmacopoeia (Polysorbate API EP), Polysorbate API JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Polysorbate API USP).
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