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