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