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API SUPPLIERS
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ABOUT THIS PAGE
A Khellin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Khellin, including repackagers and relabelers. The FDA regulates Khellin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Khellin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Khellin supplier is an individual or a company that provides Khellin active pharmaceutical ingredient (API) or Khellin finished formulations upon request. The Khellin suppliers may include Khellin API manufacturers, exporters, distributors and traders.
click here to find a list of Khellin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Khellin DMF (Drug Master File) is a document detailing the whole manufacturing process of Khellin active pharmaceutical ingredient (API) in detail. Different forms of Khellin DMFs exist exist since differing nations have different regulations, such as Khellin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Khellin DMF submitted to regulatory agencies in the US is known as a USDMF. Khellin USDMF includes data on Khellin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Khellin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Khellin suppliers with USDMF on PharmaCompass.
Khellin 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 Khellin 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 Khellin GMP manufacturer or Khellin GMP API supplier for your needs.
A Khellin CoA (Certificate of Analysis) is a formal document that attests to Khellin's compliance with Khellin specifications and serves as a tool for batch-level quality control.
Khellin CoA mostly includes findings from lab analyses of a specific batch. For each Khellin 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.
Khellin may be tested according to a variety of international standards, such as European Pharmacopoeia (Khellin EP), Khellin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Khellin USP).
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