01 1Stepan Company
01 1LATHANOL LAL
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5973
Submission : 1985-07-26
Status : Inactive
Type : II
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A Lathanol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lathanol, including repackagers and relabelers. The FDA regulates Lathanol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lathanol 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 Lathanol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Lathanol supplier is an individual or a company that provides Lathanol active pharmaceutical ingredient (API) or Lathanol finished formulations upon request. The Lathanol suppliers may include Lathanol API manufacturers, exporters, distributors and traders.
click here to find a list of Lathanol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Lathanol DMF (Drug Master File) is a document detailing the whole manufacturing process of Lathanol active pharmaceutical ingredient (API) in detail. Different forms of Lathanol DMFs exist exist since differing nations have different regulations, such as Lathanol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lathanol DMF submitted to regulatory agencies in the US is known as a USDMF. Lathanol USDMF includes data on Lathanol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lathanol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lathanol suppliers with USDMF on PharmaCompass.
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