01 1Olon S.p.A
01 1ALITRETINOIN
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-06-10
Pay. Date : 2015-09-22
DMF Number : 27553
Submission : 2013-09-10
Status : Active
Type : II
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A Panretin Gel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Panretin Gel, including repackagers and relabelers. The FDA regulates Panretin Gel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Panretin Gel 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 Panretin Gel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Panretin Gel supplier is an individual or a company that provides Panretin Gel active pharmaceutical ingredient (API) or Panretin Gel finished formulations upon request. The Panretin Gel suppliers may include Panretin Gel API manufacturers, exporters, distributors and traders.
click here to find a list of Panretin Gel suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Panretin Gel DMF (Drug Master File) is a document detailing the whole manufacturing process of Panretin Gel active pharmaceutical ingredient (API) in detail. Different forms of Panretin Gel DMFs exist exist since differing nations have different regulations, such as Panretin Gel USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Panretin Gel DMF submitted to regulatory agencies in the US is known as a USDMF. Panretin Gel USDMF includes data on Panretin Gel's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Panretin Gel USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Panretin Gel suppliers with USDMF on PharmaCompass.
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