01 1Symrise
02 1Blank
01 1NEO HELIOPAN OS
02 1NEO HELIOPAN OS (2-ETHYLHEXYL SALICYLATE)
01 1Germany
02 1Blank
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20590
Submission : 2007-05-23
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9523
Submission : 1992-02-07
Status : Inactive
Type : II
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A Octisalate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Octisalate, including repackagers and relabelers. The FDA regulates Octisalate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Octisalate 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 Octisalate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Octisalate supplier is an individual or a company that provides Octisalate active pharmaceutical ingredient (API) or Octisalate finished formulations upon request. The Octisalate suppliers may include Octisalate API manufacturers, exporters, distributors and traders.
click here to find a list of Octisalate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Octisalate DMF (Drug Master File) is a document detailing the whole manufacturing process of Octisalate active pharmaceutical ingredient (API) in detail. Different forms of Octisalate DMFs exist exist since differing nations have different regulations, such as Octisalate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Octisalate DMF submitted to regulatory agencies in the US is known as a USDMF. Octisalate USDMF includes data on Octisalate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Octisalate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Octisalate suppliers with USDMF on PharmaCompass.
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