Synopsis
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
VMF
0
FDF
0
Europe
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS0
EDQM
0
USP
0
JP
0
Others
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
0
News #PharmaBuzz
US Medicaid
NA
Annual Reports
NA
Finished Drug Prices
NA
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/VIAL
USFDA APPLICATION NUMBER - 65430
DOSAGE - INJECTABLE;INJECTION - EQ 2GM BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 2GM BASE/VIAL
USFDA APPLICATION NUMBER - 65430
Related Excipient Companies
Parenteral
Fillers, Diluents & Binders
Market Place
ABOUT THIS PAGE
A Cefotetan Disodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefotetan Disodium, including repackagers and relabelers. The FDA regulates Cefotetan Disodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefotetan Disodium 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 Disodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cefotetan Disodium supplier is an individual or a company that provides Cefotetan Disodium active pharmaceutical ingredient (API) or Cefotetan Disodium finished formulations upon request. The Cefotetan Disodium suppliers may include Cefotetan Disodium API manufacturers, exporters, distributors and traders.
click here to find a list of Cefotetan Disodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cefotetan Disodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Cefotetan Disodium active pharmaceutical ingredient (API) in detail. Different forms of Cefotetan Disodium DMFs exist exist since differing nations have different regulations, such as Cefotetan Disodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cefotetan Disodium DMF submitted to regulatory agencies in the US is known as a USDMF. Cefotetan Disodium USDMF includes data on Cefotetan Disodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cefotetan Disodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cefotetan Disodium suppliers with USDMF on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Cefotetan Disodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cefotetan Disodium API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Cefotetan Disodium as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Cefotetan Disodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cefotetan Disodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cefotetan Disodium suppliers with NDC on PharmaCompass.
Cefotetan Disodium 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 Disodium 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 Disodium GMP manufacturer or Cefotetan Disodium GMP API supplier for your needs.
A Cefotetan Disodium CoA (Certificate of Analysis) is a formal document that attests to Cefotetan Disodium's compliance with Cefotetan Disodium specifications and serves as a tool for batch-level quality control.
Cefotetan Disodium CoA mostly includes findings from lab analyses of a specific batch. For each Cefotetan Disodium 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 Disodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Cefotetan Disodium EP), Cefotetan Disodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cefotetan Disodium USP).
LOOKING FOR A SUPPLIER?
