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