01 1PCAS
01 1ROLUPERIDONE HYDROCHLORIDE
01 1France
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36423
Submission : 2021-11-22
Status : Active
Type : II
A Roluperidone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Roluperidone, including repackagers and relabelers. The FDA regulates Roluperidone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Roluperidone 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 Roluperidone supplier is an individual or a company that provides Roluperidone active pharmaceutical ingredient (API) or Roluperidone finished formulations upon request. The Roluperidone suppliers may include Roluperidone API manufacturers, exporters, distributors and traders.
click here to find a list of Roluperidone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Roluperidone DMF (Drug Master File) is a document detailing the whole manufacturing process of Roluperidone active pharmaceutical ingredient (API) in detail. Different forms of Roluperidone DMFs exist exist since differing nations have different regulations, such as Roluperidone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Roluperidone DMF submitted to regulatory agencies in the US is known as a USDMF. Roluperidone USDMF includes data on Roluperidone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Roluperidone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Roluperidone suppliers with USDMF on PharmaCompass.
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