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