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