01 1Kopran
01 1BIAPENEM STERILE
01 1India
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34914
Submission : 2020-06-16
Status : Inactive
Type : II
10
PharmaCompass offers a list of Biapenem API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Biapenem manufacturer or Biapenem supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Biapenem manufacturer or Biapenem supplier.
A Biapenem manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Biapenem, including repackagers and relabelers. The FDA regulates Biapenem manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Biapenem 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 Biapenem manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Biapenem supplier is an individual or a company that provides Biapenem active pharmaceutical ingredient (API) or Biapenem finished formulations upon request. The Biapenem suppliers may include Biapenem API manufacturers, exporters, distributors and traders.
click here to find a list of Biapenem suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Biapenem DMF (Drug Master File) is a document detailing the whole manufacturing process of Biapenem active pharmaceutical ingredient (API) in detail. Different forms of Biapenem DMFs exist exist since differing nations have different regulations, such as Biapenem USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Biapenem DMF submitted to regulatory agencies in the US is known as a USDMF. Biapenem USDMF includes data on Biapenem's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Biapenem USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Biapenem suppliers with USDMF on PharmaCompass.
