01 1Piramal Enterprises Limited
01 1NORPROSTOL
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30315
Submission : 2016-04-15
Status : Active
Type : II
A Norprostol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Norprostol, including repackagers and relabelers. The FDA regulates Norprostol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Norprostol 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 Norprostol supplier is an individual or a company that provides Norprostol active pharmaceutical ingredient (API) or Norprostol finished formulations upon request. The Norprostol suppliers may include Norprostol API manufacturers, exporters, distributors and traders.
click here to find a list of Norprostol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Norprostol DMF (Drug Master File) is a document detailing the whole manufacturing process of Norprostol active pharmaceutical ingredient (API) in detail. Different forms of Norprostol DMFs exist exist since differing nations have different regulations, such as Norprostol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Norprostol DMF submitted to regulatory agencies in the US is known as a USDMF. Norprostol USDMF includes data on Norprostol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Norprostol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Norprostol suppliers with USDMF on PharmaCompass.
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