01 1BASF
02 1Pfizer Inc
01 1PLEXIGEL (POLYETHYLENE OINT. BASE)
02 1POLYETHYLENE GLYCOL 3350
01 1Germany
02 1U.S.A
01 1Active
02 1Inactive
01 1Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-10
Pay. Date : 2013-08-29
DMF Number : 16946
Submission : 2003-11-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2358
Submission : 1974-11-18
Status : Inactive
Type : II
A Polyethylene Glycol Monostearate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Polyethylene Glycol Monostearate, including repackagers and relabelers. The FDA regulates Polyethylene Glycol Monostearate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Polyethylene Glycol Monostearate 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 Polyethylene Glycol Monostearate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Polyethylene Glycol Monostearate supplier is an individual or a company that provides Polyethylene Glycol Monostearate active pharmaceutical ingredient (API) or Polyethylene Glycol Monostearate finished formulations upon request. The Polyethylene Glycol Monostearate suppliers may include Polyethylene Glycol Monostearate API manufacturers, exporters, distributors and traders.
click here to find a list of Polyethylene Glycol Monostearate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Polyethylene Glycol Monostearate DMF (Drug Master File) is a document detailing the whole manufacturing process of Polyethylene Glycol Monostearate active pharmaceutical ingredient (API) in detail. Different forms of Polyethylene Glycol Monostearate DMFs exist exist since differing nations have different regulations, such as Polyethylene Glycol Monostearate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Polyethylene Glycol Monostearate DMF submitted to regulatory agencies in the US is known as a USDMF. Polyethylene Glycol Monostearate USDMF includes data on Polyethylene Glycol Monostearate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Polyethylene Glycol Monostearate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Polyethylene Glycol Monostearate suppliers with USDMF on PharmaCompass.
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