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