01 1MSN Laboratories
01 1ROLAPITANT HYDROCHLORIDE
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34716
Submission : 2020-03-29
Status : Active
Type : II
A Rolapitant HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rolapitant HCl, including repackagers and relabelers. The FDA regulates Rolapitant HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rolapitant HCl 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 Rolapitant HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rolapitant HCl supplier is an individual or a company that provides Rolapitant HCl active pharmaceutical ingredient (API) or Rolapitant HCl finished formulations upon request. The Rolapitant HCl suppliers may include Rolapitant HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Rolapitant HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rolapitant HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Rolapitant HCl active pharmaceutical ingredient (API) in detail. Different forms of Rolapitant HCl DMFs exist exist since differing nations have different regulations, such as Rolapitant HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rolapitant HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Rolapitant HCl USDMF includes data on Rolapitant HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rolapitant HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rolapitant HCl suppliers with USDMF on PharmaCompass.
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