01 1RITA Corporation
01 1LANOLIN
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12789
Submission : 1997-12-17
Status : Inactive
Type : IV
A Lanolin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lanolin, including repackagers and relabelers. The FDA regulates Lanolin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lanolin 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 Lanolin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lanolin supplier is an individual or a company that provides Lanolin active pharmaceutical ingredient (API) or Lanolin finished formulations upon request. The Lanolin suppliers may include Lanolin API manufacturers, exporters, distributors and traders.
click here to find a list of Lanolin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lanolin DMF (Drug Master File) is a document detailing the whole manufacturing process of Lanolin active pharmaceutical ingredient (API) in detail. Different forms of Lanolin DMFs exist exist since differing nations have different regulations, such as Lanolin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lanolin DMF submitted to regulatory agencies in the US is known as a USDMF. Lanolin USDMF includes data on Lanolin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lanolin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lanolin suppliers with USDMF on PharmaCompass.
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