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