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