01 1Cilag AG
01 1SUCCIMER
01 1Switzerland
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7947
Submission : 1989-02-24
Status : Inactive
Type : II
A Succimer manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Succimer, including repackagers and relabelers. The FDA regulates Succimer manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Succimer API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Succimer supplier is an individual or a company that provides Succimer active pharmaceutical ingredient (API) or Succimer finished formulations upon request. The Succimer suppliers may include Succimer API manufacturers, exporters, distributors and traders.
click here to find a list of Succimer suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Succimer DMF (Drug Master File) is a document detailing the whole manufacturing process of Succimer active pharmaceutical ingredient (API) in detail. Different forms of Succimer DMFs exist exist since differing nations have different regulations, such as Succimer USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Succimer DMF submitted to regulatory agencies in the US is known as a USDMF. Succimer USDMF includes data on Succimer's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Succimer USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Succimer suppliers with USDMF on PharmaCompass.
LOOKING FOR A SUPPLIER?
