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
95
PharmaCompass offers a list of Roluperidone 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 Roluperidone manufacturer or Roluperidone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Roluperidone manufacturer or Roluperidone supplier.
PharmaCompass also assists you with knowing the Roluperidone API Price utilized in the formulation of products. Roluperidone API Price is not always fixed or binding as the Roluperidone Price is obtained through a variety of data sources. The Roluperidone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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.
