01 1Apotex Pharmachem
01 1MISOPROSTOL 4% DISPERSION ON HYDROXYPROPYL METHYLCELLULOSE (HPMC)
01 1Canada
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17567
Submission : 2004-07-22
Status : Inactive
Type : II
A Methylcellulose API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methylcellulose API, including repackagers and relabelers. The FDA regulates Methylcellulose API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methylcellulose API 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 Methylcellulose API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Methylcellulose API supplier is an individual or a company that provides Methylcellulose API active pharmaceutical ingredient (API) or Methylcellulose API finished formulations upon request. The Methylcellulose API suppliers may include Methylcellulose API API manufacturers, exporters, distributors and traders.
click here to find a list of Methylcellulose API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Methylcellulose API DMF (Drug Master File) is a document detailing the whole manufacturing process of Methylcellulose API active pharmaceutical ingredient (API) in detail. Different forms of Methylcellulose API DMFs exist exist since differing nations have different regulations, such as Methylcellulose API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methylcellulose API DMF submitted to regulatory agencies in the US is known as a USDMF. Methylcellulose API USDMF includes data on Methylcellulose API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methylcellulose API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Methylcellulose API suppliers with USDMF on PharmaCompass.
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