01 1BASF
02 1MLA Group of Industries
03 1Pfizer Inc
01 1ETHYLENE GLYCOL STEARATE (EGMS/EGDS) USP
02 1PLEXIGEL (POLYETHYLENE OINT. BASE)
03 1POLYETHYLENE GLYCOL 3350
01 1Germany
02 1India
03 1U.S.A
01 2Active
02 1Inactive
01 1Complete
02 2Blank
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 : 38354
Submission : 2023-05-08
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2358
Submission : 1974-11-18
Status : Inactive
Type : II
65
PharmaCompass offers a list of Polyethylene Glycol Monostearate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Polyethylene Glycol Monostearate manufacturer or Polyethylene Glycol Monostearate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Polyethylene Glycol Monostearate manufacturer or Polyethylene Glycol Monostearate supplier.
A Monthyle manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Monthyle, including repackagers and relabelers. The FDA regulates Monthyle manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Monthyle 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 Monthyle manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Monthyle supplier is an individual or a company that provides Monthyle active pharmaceutical ingredient (API) or Monthyle finished formulations upon request. The Monthyle suppliers may include Monthyle API manufacturers, exporters, distributors and traders.
click here to find a list of Monthyle suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Monthyle DMF (Drug Master File) is a document detailing the whole manufacturing process of Monthyle active pharmaceutical ingredient (API) in detail. Different forms of Monthyle DMFs exist exist since differing nations have different regulations, such as Monthyle USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Monthyle DMF submitted to regulatory agencies in the US is known as a USDMF. Monthyle USDMF includes data on Monthyle's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Monthyle USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Monthyle suppliers with USDMF on PharmaCompass.
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