01 1BioCatSyn (Shanghai) Biotechnology
02 1Blank
01 1ROBANE (HYDROGENATED SQUALENE)
02 1SQUALENE
01 1China
02 1Blank
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38189
Submission : 2023-03-28
Status : Active
Type : IV
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2988
Submission : 1977-07-25
Status : Inactive
Type : II
Portfolio PDF
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PharmaCompass offers a list of Squalene API API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Squalene API manufacturer or Squalene API supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Squalene API manufacturer or Squalene API supplier.
PharmaCompass also assists you with knowing the Squalene API API Price utilized in the formulation of products. Squalene API API Price is not always fixed or binding as the Squalene API Price is obtained through a variety of data sources. The Squalene API Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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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