01 1Bayer AG
01 1ROLIPRAM AS PRODUCED IN THE BERLIN PLANT
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5539
Submission : 1984-10-01
Status : Inactive
Type : II
A Rolipram manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rolipram, including repackagers and relabelers. The FDA regulates Rolipram manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rolipram 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 Rolipram supplier is an individual or a company that provides Rolipram active pharmaceutical ingredient (API) or Rolipram finished formulations upon request. The Rolipram suppliers may include Rolipram API manufacturers, exporters, distributors and traders.
click here to find a list of Rolipram suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rolipram DMF (Drug Master File) is a document detailing the whole manufacturing process of Rolipram active pharmaceutical ingredient (API) in detail. Different forms of Rolipram DMFs exist exist since differing nations have different regulations, such as Rolipram USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rolipram DMF submitted to regulatory agencies in the US is known as a USDMF. Rolipram USDMF includes data on Rolipram's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rolipram USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rolipram suppliers with USDMF on PharmaCompass.
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