GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38918
Submission : 2023-10-03
Status : Active
Type : IV
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 : 35699
Submission : 2021-04-14
Status : Active
Type : IV
Certificate Number : R0-CEP 2020-419 - Rev 00
Issue Date : 2022-04-01
Type : Chemical
Substance Number : 428
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24384
Submission : 2010-08-12
Status : Active
Type : IV
Certificate Number : R0-CEP 2000-310 - Rev 02
Issue Date : 2005-03-16
Type : TSE
Substance Number : 428
Status : Withdrawn by Holder

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24398
Submission : 2010-09-09
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26300
Submission : 2012-07-24
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35475
Submission : 2020-12-21
Status : Inactive
Type : IV
Certificate Number : R0-CEP 2020-048 - Rev 00
Issue Date : 2020-09-04
Type : Chemical
Substance Number : 428
Status : Withdrawn by Holder

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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38918
Submission : 2023-10-03
Status : Active
Type : IV
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 : 35699
Submission : 2021-04-14
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35475
Submission : 2020-12-21
Status : Inactive
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26300
Submission : 2012-07-24
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24398
Submission : 2010-09-09
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24384
Submission : 2010-08-12
Status : Active
Type : IV

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Certificate Number : R0-CEP 2020-419 - Rev 00
Status : Valid
Issue Date : 2022-04-01
Type : Chemical
Substance Number : 428
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Certificate Number : R0-CEP 2020-048 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2020-09-04
Type : Chemical
Substance Number : 428

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Polysorbate 80, Montanox 80 DF RPR D Montanox 80...
Certificate Number : R0-CEP 2000-310 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2005-03-16
Type : TSE
Substance Number : 428

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] FINISHED DOSAGE FORMULATIONS
Drug : PRIMAQUINE
Dosage Form : TABLET; ORAL
Application Number : 8316
Country : US
Patented : No
Drug : CABLIVI
Dosage Form : INJECTABLE; INJECTION
Application Number : 761112
Country : US
Patented : No
Drug : MYOZYME
Dosage Form : INJECTABLE; IV (INFUSION)
Application Number : 125141
Country : US
Patented : No
Drug : TAXOTERE
Dosage Form : INJECTABLE; INJECTION
Application Number : 20449
Country : US
Patented : No
Drug : GENGRAF
Dosage Form : CAPSULE; ORAL
Application Number : 65003
Country : US
Patented : No
Drug : FML
Dosage Form : SUSPENSION/DROPS; OPHTHALMIC
Application Number : 16851
Country : US
Patented : No
Drug : NORVIR
Dosage Form : TABLET; ORAL
Application Number : 22417
Country : US
Patented : No
Drug : KALETRA
Dosage Form : TABLET; ORAL
Application Number : 21906
Country : US
Patented : No
Drug : PRED MILD
Dosage Form : SUSPENSION/DROPS; OPHTHALMIC
Application Number : 17100
Country : US
Patented : No
NEBIVOLOL HYDROCHLORIDE; VALSARTAN
Drug : BYVALSON
Dosage Form : TABLET; ORAL
Application Number : 206302
Country : US
Patented : Yes
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]POLYSORBATE 80
Route : AURICULAR (OTIC)
CAS : 9005-65-6
UNII : 6OZP39ZG8H
Potency Amount : 0.2
Potency Unit : %

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POLYSORBATE 80
Route : AURICULAR (OTIC)
CAS : 9005-65-6
UNII : 6OZP39ZG8H
Potency Amount : 5
Potency Unit : %

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POLYSORBATE 80
Route : IM - IV
CAS : 9005-65-6
UNII : 6OZP39ZG8H
Potency Amount : 0
Potency Unit : NA

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POLYSORBATE 80
Route : INHALATION
CAS : 9005-65-6
UNII : 6OZP39ZG8H
Potency Amount : 0.02
Potency Unit : %

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POLYSORBATE 80
Route : INTRA-ARTICULAR
CAS : 9005-65-6
UNII : 6OZP39ZG8H
Potency Amount : 0.04
Potency Unit : %

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POLYSORBATE 80
Route : INTRA-ARTICULAR
CAS : 9005-65-6
UNII : 6OZP39ZG8H
Potency Amount : 0.4
Potency Unit : %

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Product Web Link
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POLYSORBATE 80
Route : INTRA-ARTICULAR
CAS : 9005-65-6
UNII : 6OZP39ZG8H
Potency Amount : 0
Potency Unit : NA

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POLYSORBATE 80
Route : INTRABURSAL
CAS : 9005-65-6
UNII : 6OZP39ZG8H
Potency Amount : 0.04
Potency Unit : %

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POLYSORBATE 80
Route : INTRADERMAL
CAS : 9005-65-6
UNII : 6OZP39ZG8H
Potency Amount : 0
Potency Unit : NA

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLYSORBATE 80
Route : INTRADERMAL
CAS : 9005-65-6
UNII : 6OZP39ZG8H
Potency Amount : 0
Potency Unit : NA

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
EXCIPIENTS BY APPLICATIONS
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Tablet
Grade : Parenteral, Oral, Topical
Category : Solubilizers
Dosage Form : Capsule, Suspension, Tablet
Grade : Oral, Topical & Parenteral
Category : Solubilizers
Application : Solubilizers
Excipient Details : Polysorbate 80 acts as solubilizer, emulsifier and wetting agent.
Excipients Web Link
Dosage Form : Gel, Softgel Capsule, Solution, Suppository
Grade : Not Available
Category : Solubilizers
Application : Solubilizers
Excipient Details : Nonionic solubilizer, emulsifier and co-emulsifier
Application : Solubilizers
Excipient Details : Polysorbate 80 is widely used as a surfactant, emulsifier, solubilizer, and stabilizer.
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Gel, Paste, Shampoo, Solution, Syrup, Tablet
Grade : Topical, Oral
Category : Solubilizers
Brand Name : MONTANOX 80 PHA PREMIUM
Application : Solubilizers
Excipient Details : Non-Ionic Hydrophilic Surfactant, Emulsifier, Solubilizer
Pharmacopoeia Ref : Ph.Eur, USP-NF
Technical Specs : HLB: 15, EO: 20; EXCiPACT
Ingredient(s) : Polysorbate 80
Brand Name : Polysorbate 80 Multi-Compendial
Application : Solubilizers
Excipient Details : A & C's Polysorbate 80 multi-compendial is an excipient which meets USP-NF, EP, BP and JP monographs.
Excipients Web Link
Brand Name : Polysorbate 80 NF
Application : Solubilizers
Excipient Details : A & C's Polysorbate 80 is an excipient which meets the NF monograph.
Excipients Web Link
Dosage Form : Capsule, Cream / Lotion / Ointment, Tablet
Grade : Oral, Topical
Category : Solubilizers
Brand Name : MONTANOX 80 PHA PREMIUM
Application : Solubilizers
Pharmacopoeia Ref : USP-NF, EP, JP
Technical Specs : Non-Ionic Hydrophilic surfactant, Emulsifier (o/w emulsion), Solu...
Ingredient(s) : Polysorbate 80
Dosage Form : Injectable / Parenteral, Ophthalmic Solution, Nasal Solution
Grade : Injectable
Category : Solubilizers
Application : Solubilizers
Excipient Details : Non-Ionic Hydrophilic Surfactant, Emulsifier, Solubilizer
Dosage Form : Injectable / Parenteral, Ophthalmic Solution, Nasal Solution
Grade : Injectable
Category : Solubilizers
Application : Solubilizers
Excipient Details : Non-Ionic Hydrophilic Surfactant, Emulsifier, Solubilizer
Dosage Form : Cream / Lotion / Ointment, Emulsion, Injectable / Parenteral
Grade : Parenteral, Oral, Topical
Category : Emulsifying Agents
Dosage Form : Injectable / Parenteral, Tablet
Grade : Oral & Parenteral
Category : Emulsifying Agents
Application : Emulsifying Agents
Excipient Details : Polysorbate 80 is widely used as a surfactant, emulsifier, solubilizer, and stabilizer.
Dosage Form : Capsule, Cream / Lotion / Ointment, Tablet
Grade : Oral, Topical
Category : Emulsifying Agents
Brand Name : MONTANOX 80 PHA PREMIUM
Application : Emulsifying Agents
Pharmacopoeia Ref : USP-NF, EP, JP
Technical Specs : Non-Ionic Hydrophilic surfactant, Emulsifier (o/w emulsion), Solu...
Ingredient(s) : Polysorbate 80
Application : Emulsifying Agents
Excipient Details : Thickener, Emulsifier, Stabilizer, Texturizing agent, pH Independent & Non Thixotropic polymer for Topical Range (Skin,Vaginal & Anal mucosa)
Pharmacopoeia Ref : In house having US DMF Type IV...
Technical Specs : Ready to use liquid polymer for topical applications (Gel / Cream...
Ingredient(s) : Polysorbate 80
Application : Rheology Modifiers
Excipient Details : Thickener, Emulsifier, Stabilizer, Texturizing agent, pH Independent & Non Thixotropic polymer for Topical Range (Skin,Vaginal & Anal mucosa)
Pharmacopoeia Ref : In house having US DMF Type IV...
Technical Specs : Ready to use liquid polymer for topical applications (Gel / Cream...
Ingredient(s) : Polysorbate 80
Application : API Stability Enhancers
Excipient Details : Polysorbate 80 in dry powder form, a solubilizing agent acts as a surfactant and increases the solubility of various oral dosage forms.
Pharmacopoeia Ref : USP-NF, EP, JP & having US DMF
Technical Specs : Solubilizer in powder form, used in directly compressible dosage ...
Ingredient(s) : Polysorbate 80
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REF. STANDARDS & IMPURITIES