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ABOUT THIS PAGE
A Hydroxyethyl Starch manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydroxyethyl Starch, including repackagers and relabelers. The FDA regulates Hydroxyethyl Starch manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydroxyethyl Starch 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 Hydroxyethyl Starch manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydroxyethyl Starch supplier is an individual or a company that provides Hydroxyethyl Starch active pharmaceutical ingredient (API) or Hydroxyethyl Starch finished formulations upon request. The Hydroxyethyl Starch suppliers may include Hydroxyethyl Starch API manufacturers, exporters, distributors and traders.
click here to find a list of Hydroxyethyl Starch suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Hydroxyethyl Starch Drug Master File in Korea (Hydroxyethyl Starch KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hydroxyethyl Starch. The MFDS reviews the Hydroxyethyl Starch KDMF as part of the drug registration process and uses the information provided in the Hydroxyethyl Starch KDMF to evaluate the safety and efficacy of the drug.
After submitting a Hydroxyethyl Starch KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Hydroxyethyl Starch API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Hydroxyethyl Starch suppliers with KDMF on PharmaCompass.
A Hydroxyethyl Starch CEP of the European Pharmacopoeia monograph is often referred to as a Hydroxyethyl Starch Certificate of Suitability (COS). The purpose of a Hydroxyethyl Starch CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hydroxyethyl Starch EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hydroxyethyl Starch to their clients by showing that a Hydroxyethyl Starch CEP has been issued for it. The manufacturer submits a Hydroxyethyl Starch CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hydroxyethyl Starch CEP holder for the record. Additionally, the data presented in the Hydroxyethyl Starch CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hydroxyethyl Starch DMF.
A Hydroxyethyl Starch CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hydroxyethyl Starch 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 Hydroxyethyl Starch suppliers with CEP (COS) on PharmaCompass.
Hydroxyethyl Starch 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 Hydroxyethyl Starch 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 Hydroxyethyl Starch GMP manufacturer or Hydroxyethyl Starch GMP API supplier for your needs.
A Hydroxyethyl Starch CoA (Certificate of Analysis) is a formal document that attests to Hydroxyethyl Starch's compliance with Hydroxyethyl Starch specifications and serves as a tool for batch-level quality control.
Hydroxyethyl Starch CoA mostly includes findings from lab analyses of a specific batch. For each Hydroxyethyl Starch 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.
Hydroxyethyl Starch may be tested according to a variety of international standards, such as European Pharmacopoeia (Hydroxyethyl Starch EP), Hydroxyethyl Starch JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hydroxyethyl Starch USP).
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