01 1Gattefosse
01 1PRECIROL ATO 5
01 1France
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5116
Submission : 1983-05-23
Status : Active
Type : IV
A Precirol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Precirol, including repackagers and relabelers. The FDA regulates Precirol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Precirol 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 Precirol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Precirol supplier is an individual or a company that provides Precirol active pharmaceutical ingredient (API) or Precirol finished formulations upon request. The Precirol suppliers may include Precirol API manufacturers, exporters, distributors and traders.
click here to find a list of Precirol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Precirol DMF (Drug Master File) is a document detailing the whole manufacturing process of Precirol active pharmaceutical ingredient (API) in detail. Different forms of Precirol DMFs exist exist since differing nations have different regulations, such as Precirol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Precirol DMF submitted to regulatory agencies in the US is known as a USDMF. Precirol USDMF includes data on Precirol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Precirol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Precirol suppliers with USDMF on PharmaCompass.
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