01 1BioCatSyn (Shanghai) Biotechnology
02 1SAFC
03 1Blank
01 1ROBANE (HYDROGENATED SQUALENE)
02 2SQUALENE
01 1China
02 1U.S.A
03 1Blank
01 1Active
02 2Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38189
Submission : 2023-03-28
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12515
Submission : 1997-05-23
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2988
Submission : 1977-07-25
Status : Inactive
Type : II
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Corporate PDF
A Squalene API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Squalene API, including repackagers and relabelers. The FDA regulates Squalene API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Squalene 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 Squalene API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Squalene API supplier is an individual or a company that provides Squalene API active pharmaceutical ingredient (API) or Squalene API finished formulations upon request. The Squalene API suppliers may include Squalene API API manufacturers, exporters, distributors and traders.
click here to find a list of Squalene API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Squalene API DMF (Drug Master File) is a document detailing the whole manufacturing process of Squalene API active pharmaceutical ingredient (API) in detail. Different forms of Squalene API DMFs exist exist since differing nations have different regulations, such as Squalene API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Squalene API DMF submitted to regulatory agencies in the US is known as a USDMF. Squalene API USDMF includes data on Squalene API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Squalene API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Squalene API suppliers with USDMF on PharmaCompass.
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