01 1Blank
01 1ALUMINIUM STEARATE
01 1Blank
01 1Active
01 1Blank
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35666
Submission : 2021-02-25
Status : Active
Type : IV
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Aluminum stearate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aluminum stearate, including repackagers and relabelers. The FDA regulates Aluminum stearate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aluminum stearate 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 Aluminum stearate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aluminum stearate supplier is an individual or a company that provides Aluminum stearate active pharmaceutical ingredient (API) or Aluminum stearate finished formulations upon request. The Aluminum stearate suppliers may include Aluminum stearate API manufacturers, exporters, distributors and traders.
click here to find a list of Aluminum stearate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aluminum stearate DMF (Drug Master File) is a document detailing the whole manufacturing process of Aluminum stearate active pharmaceutical ingredient (API) in detail. Different forms of Aluminum stearate DMFs exist exist since differing nations have different regulations, such as Aluminum stearate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aluminum stearate DMF submitted to regulatory agencies in the US is known as a USDMF. Aluminum stearate USDMF includes data on Aluminum stearate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aluminum stearate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aluminum stearate suppliers with USDMF on PharmaCompass.
LOOKING FOR A SUPPLIER?