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 : 41428
Submission : 2025-03-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12805
Submission : 1997-12-15
Status : Active
Type : IV

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
VMF Number : 3744
Submission : 1979-06-05
Status : Inactive
Type : II

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FINISHED DOSAGE FORMULATIONS
PROPYLENE GLYCOL
Route : AURICULAR (OTIC)
CAS : 57-55-6
UNII : 6DC9Q167V3
Potency Amount : 0
Potency Unit : NA

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PROPYLENE GLYCOL
Route : AURICULAR (OTIC)
CAS : 57-55-6
UNII : 6DC9Q167V3
Potency Amount : 0
Potency Unit : NA

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PROPYLENE GLYCOL
Route : AURICULAR (OTIC)
CAS : 57-55-6
UNII : 6DC9Q167V3
Potency Amount : 0
Potency Unit : NA

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PROPYLENE GLYCOL
Route : AURICULAR (OTIC)
CAS : 57-55-6
UNII : 6DC9Q167V3
Potency Amount : 10
Potency Unit : %

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PROPYLENE GLYCOL
Route : BUCCAL
CAS : 57-55-6
UNII : 6DC9Q167V3
Potency Amount : 1.48
Potency Unit : MG

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PROPYLENE GLYCOL
Route : BUCCAL
CAS : 57-55-6
UNII : 6DC9Q167V3
Potency Amount : 1.02
Potency Unit : MG

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PROPYLENE GLYCOL
Route : DENTAL
CAS : 57-55-6
UNII : 6DC9Q167V3
Potency Amount : 0
Potency Unit : NA

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PROPYLENE GLYCOL
Route : DENTAL
CAS : 57-55-6
UNII : 6DC9Q167V3
Potency Amount : 0
Potency Unit : NA

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PROPYLENE GLYCOL
Route : DENTAL
CAS : 57-55-6
UNII : 6DC9Q167V3
Potency Amount : 2
Potency Unit : %

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PROPYLENE GLYCOL
Route : EXTRACORPOREAL
CAS : 57-55-6
UNII : 6DC9Q167V3
Potency Amount : 5
Potency Unit : %

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EXCIPIENTS BY APPLICATIONS
Application : Topical
Excipient Details : Hydrosol 50 is used as a solubilizer and emulsifying agent in oral and topical liquid and semi-solid dosage forms.
Application : Topical
Excipient Details : Liquid plasticizer with high ADI, hydrophilic solvent & humectant in emulsions, skin penetration enhancer in topical formulaitons.
Pharmacopoeia Ref : Ph. Eur., JP, FCC, USP
Technical Specs : Not Available
Ingredient(s) : Propylene Glycol
Dosage Form : Cream / Lotion / Ointment, Gel, Solution
Grade : Oral, Topical
Category : Solubilizers
Application : Solubilizers
Excipient Details : Hydrosol 50 is used as a solubilizer and emulsifying agent in oral and topical liquid and semi-solid dosage forms.
Application : Solubilizers
Excipient Details : Liquid plasticizer with high ADI, hydrophilic solvent & humectant in emulsions, skin penetration enhancer in topical formulaitons.
Pharmacopoeia Ref : Ph. Eur., JP, FCC, USP
Technical Specs : Not Available
Ingredient(s) : Propylene Glycol
Dosage Form : Cream / Lotion / Ointment, Gel, Solution
Grade : Oral, Topical
Category : Emulsifying Agents
Application : Emulsifying Agents
Excipient Details : Hydrosol 50 is used as a solubilizer and emulsifying agent in oral and topical liquid and semi-solid dosage forms.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral, Topical
Category : Thickeners and Stabilizers
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REF. STANDARDS & IMPURITIES