01 1Jubilant Generics
01 1PINAVERIUM BROMIDE
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21990
Submission : 2008-09-26
Status : Active
Type : II
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A Dicetel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dicetel, including repackagers and relabelers. The FDA regulates Dicetel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dicetel 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 Dicetel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Dicetel supplier is an individual or a company that provides Dicetel active pharmaceutical ingredient (API) or Dicetel finished formulations upon request. The Dicetel suppliers may include Dicetel API manufacturers, exporters, distributors and traders.
click here to find a list of Dicetel suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Dicetel DMF (Drug Master File) is a document detailing the whole manufacturing process of Dicetel active pharmaceutical ingredient (API) in detail. Different forms of Dicetel DMFs exist exist since differing nations have different regulations, such as Dicetel USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dicetel DMF submitted to regulatory agencies in the US is known as a USDMF. Dicetel USDMF includes data on Dicetel's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dicetel USDMF is kept confidential to protect the manufacturer’s intellectual property.
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