01 1Shionogi
01 1COMPOUND 7432-S
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6883
Submission : 1987-03-18
Status : Inactive
Type : II
57
PharmaCompass offers a list of Ceftibuten API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Ceftibuten manufacturer or Ceftibuten supplier for your needs.
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PharmaCompass also assists you with knowing the Ceftibuten API Price utilized in the formulation of products. Ceftibuten API Price is not always fixed or binding as the Ceftibuten Price is obtained through a variety of data sources. The Ceftibuten Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Isocef manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isocef, including repackagers and relabelers. The FDA regulates Isocef manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isocef API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Isocef supplier is an individual or a company that provides Isocef active pharmaceutical ingredient (API) or Isocef finished formulations upon request. The Isocef suppliers may include Isocef API manufacturers, exporters, distributors and traders.
click here to find a list of Isocef suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Isocef DMF (Drug Master File) is a document detailing the whole manufacturing process of Isocef active pharmaceutical ingredient (API) in detail. Different forms of Isocef DMFs exist exist since differing nations have different regulations, such as Isocef USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Isocef DMF submitted to regulatory agencies in the US is known as a USDMF. Isocef USDMF includes data on Isocef's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isocef USDMF is kept confidential to protect the manufacturer’s intellectual property.
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