01 1Croda
02 1Hubei Gedian Humanwell Pharmaceutical
01 1POLYSORBATE 80 (FOR INJECTION)
02 1TWEEN 80 HP-LQ-(MH)
01 1China
02 1U.S.A
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17071
Submission : 2003-12-02
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33606
Submission : 2020-01-07
Status : Active
Type : IV
A Polysorbate API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Polysorbate API, including repackagers and relabelers. The FDA regulates Polysorbate API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Polysorbate 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 Polysorbate API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Polysorbate API supplier is an individual or a company that provides Polysorbate API active pharmaceutical ingredient (API) or Polysorbate API finished formulations upon request. The Polysorbate API suppliers may include Polysorbate API API manufacturers, exporters, distributors and traders.
click here to find a list of Polysorbate API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Polysorbate API DMF (Drug Master File) is a document detailing the whole manufacturing process of Polysorbate API active pharmaceutical ingredient (API) in detail. Different forms of Polysorbate API DMFs exist exist since differing nations have different regulations, such as Polysorbate API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Polysorbate API DMF submitted to regulatory agencies in the US is known as a USDMF. Polysorbate API USDMF includes data on Polysorbate API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Polysorbate API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Polysorbate API suppliers with USDMF on PharmaCompass.
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