Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36565
Submission : 2022-07-05
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38299
Submission : 2023-07-26
Status : Active
Type : IV

Certificate Number : CEP 2023-322 - Rev 00
Issue Date : 2025-03-17
Type : Chemical
Substance Number : 426
Status : Valid

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FINISHED DOSAGE FORMULATIONS
POLYSORBATE 20
Route : AURICULAR (OTIC)
CAS : 9005-64-5
UNII : 7T1F30V5YH
Potency Amount : 0.1
Potency Unit : %

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POLYSORBATE 20
Route : IM - SC
CAS : 9005-64-5
UNII : 7T1F30V5YH
Potency Amount : 0.0005
Potency Unit : %

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POLYSORBATE 20
Route : INTRAMUSCULAR
CAS : 9005-64-5
UNII : 7T1F30V5YH
Potency Amount : 0
Potency Unit : NA

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POLYSORBATE 20
Route : INTRAMUSCULAR
CAS : 9005-64-5
UNII : 7T1F30V5YH
Potency Amount : 0.5
Potency Unit : %

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POLYSORBATE 20
Route : INTRAMUSCULAR
CAS : 9005-64-5
UNII : 7T1F30V5YH
Potency Amount : 0.01
Potency Unit : %

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POLYSORBATE 20
Route : INTRAMUSCULAR
CAS : 9005-64-5
UNII : 7T1F30V5YH
Potency Amount : 0.029
Potency Unit : %W/V

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POLYSORBATE 20
Route : INTRAMUSCULAR
CAS : 9005-64-5
UNII : 7T1F30V5YH
Potency Amount : 1
Potency Unit : %

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POLYSORBATE 20
Route : INTRAMUSCULAR
CAS : 9005-64-5
UNII : 7T1F30V5YH
Potency Amount : 1
Potency Unit : %W/V

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POLYSORBATE 20
Route : INTRAMUSCULAR
CAS : 9005-64-5
UNII : 7T1F30V5YH
Potency Amount : 1.8
Potency Unit : %

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POLYSORBATE 20
Route : INTRAVENOUS
CAS : 9005-64-5
UNII : 7T1F30V5YH
Potency Amount : 4.8
Potency Unit : %

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EXCIPIENTS BY APPLICATIONS
Application : Parenteral
Excipient Details : Used as surfactant agent in cell culture media, in protein purification and in injectable formulations.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised pa...
Ingredient(s) : Tween 20 Excipient
Dosage Form : Injectable / Parenteral, Nasal Solution, Ophthalmic Solution
Grade : Injectable
Category : Parenteral
Application : Parenteral
Excipient Details : Non-Ionic Hydrophilic Surfactant, Emulsifier, Solubilizer
Pharmacopoeia Ref : Ph.Eur, USP-NF, JPE
Technical Specs : EXCiPACT
Ingredient(s) : Tween 20 Excipient
MARKET PLACE
REF. STANDARDS & IMPURITIES