01 1BASF
01 1POLOXALENE USP
01 1Germany
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18382
Submission : 2005-05-27
Status : Active
Type : II
47
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A Lutrol F manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lutrol F, including repackagers and relabelers. The FDA regulates Lutrol F manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lutrol F 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 Lutrol F manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Lutrol F supplier is an individual or a company that provides Lutrol F active pharmaceutical ingredient (API) or Lutrol F finished formulations upon request. The Lutrol F suppliers may include Lutrol F API manufacturers, exporters, distributors and traders.
click here to find a list of Lutrol F suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Lutrol F DMF (Drug Master File) is a document detailing the whole manufacturing process of Lutrol F active pharmaceutical ingredient (API) in detail. Different forms of Lutrol F DMFs exist exist since differing nations have different regulations, such as Lutrol F USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lutrol F DMF submitted to regulatory agencies in the US is known as a USDMF. Lutrol F USDMF includes data on Lutrol F's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lutrol F USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lutrol F suppliers with USDMF on PharmaCompass.
