01 1SHIN-ETSU
02 1Shin-etsu Chemical
01 1METOLOSE VF GRADES
02 1PHARMACOAT AND METOLOSE (LOW DEGREE OF POLYMERIZATION) METOLOSE (HIGH DEGREE OF POLYMERIZATION)
01 1Germany
02 1Japan
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3748
Submission : 1980-03-10
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35374
Submission : 2020-11-09
Status : Active
Type : IV
A Hypromellosum manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hypromellosum, including repackagers and relabelers. The FDA regulates Hypromellosum manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hypromellosum 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 Hypromellosum supplier is an individual or a company that provides Hypromellosum active pharmaceutical ingredient (API) or Hypromellosum finished formulations upon request. The Hypromellosum suppliers may include Hypromellosum API manufacturers, exporters, distributors and traders.
click here to find a list of Hypromellosum suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hypromellosum DMF (Drug Master File) is a document detailing the whole manufacturing process of Hypromellosum active pharmaceutical ingredient (API) in detail. Different forms of Hypromellosum DMFs exist exist since differing nations have different regulations, such as Hypromellosum USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hypromellosum DMF submitted to regulatory agencies in the US is known as a USDMF. Hypromellosum USDMF includes data on Hypromellosum's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hypromellosum USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hypromellosum suppliers with USDMF on PharmaCompass.
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