01 1MLA Group
02 1Blank
01 2ZINC STEARATE
01 1India
02 1Blank
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35105
Submission : 2020-08-26
Status : Active
Type : IV
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35663
Submission : 2021-02-25
Status : Active
Type : IV
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A Zinc Stearate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zinc Stearate, including repackagers and relabelers. The FDA regulates Zinc Stearate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zinc 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.
A Zinc Stearate supplier is an individual or a company that provides Zinc Stearate active pharmaceutical ingredient (API) or Zinc Stearate finished formulations upon request. The Zinc Stearate suppliers may include Zinc Stearate API manufacturers, exporters, distributors and traders.
click here to find a list of Zinc Stearate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zinc Stearate DMF (Drug Master File) is a document detailing the whole manufacturing process of Zinc Stearate active pharmaceutical ingredient (API) in detail. Different forms of Zinc Stearate DMFs exist exist since differing nations have different regulations, such as Zinc Stearate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zinc Stearate DMF submitted to regulatory agencies in the US is known as a USDMF. Zinc Stearate USDMF includes data on Zinc Stearate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zinc Stearate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zinc Stearate suppliers with USDMF on PharmaCompass.
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