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Status : Withdrawn by Holder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 : II
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 : Valid
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 : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24384
Submission : 2010-08-12
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
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 : AMBIEN
Dosage Form : TABLET; ORAL
Application Number : 19908
Country : US
Patented : No
Drug : PRIMAQUINE
Dosage Form : TABLET; ORAL
Application Number : 8316
Country : US
Patented : No
Drug : GENGRAF
Dosage Form : CAPSULE; ORAL
Application Number : 65003
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
Drug : PRED FORTE
Dosage Form : SUSPENSION/DROPS; OPHTHALMIC
Application Number : 17011
Country : US
Patented : No
POLYSORBATE 80
Route : AURICULAR (OTIC)
CAS : 9005656
UNII : 6OZP39ZG8H
Potency Amount : 0.2
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLYSORBATE 80
Route : AURICULAR (OTIC)
CAS : 9005656
UNII : 6OZP39ZG8H
Potency Amount : 5
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLYSORBATE 80
Route : IM - IV
CAS : 9005656
UNII : 6OZP39ZG8H
Potency Amount : 0
Potency Unit : NA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLYSORBATE 80
Route : INHALATION
CAS : 9005656
UNII : 6OZP39ZG8H
Potency Amount : 0.02
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLYSORBATE 80
Route : INTRA-ARTICULAR
CAS : 9005656
UNII : 6OZP39ZG8H
Potency Amount : 0.04
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLYSORBATE 80
Route : INTRA-ARTICULAR
CAS : 9005656
UNII : 6OZP39ZG8H
Potency Amount : 0.4
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLYSORBATE 80
Route : INTRA-ARTICULAR
CAS : 9005656
UNII : 6OZP39ZG8H
Potency Amount : 0
Potency Unit : NA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLYSORBATE 80
Route : INTRABURSAL
CAS : 9005656
UNII : 6OZP39ZG8H
Potency Amount : 0.04
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLYSORBATE 80
Route : INTRADERMAL
CAS : 9005656
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 : 9005656
UNII : 6OZP39ZG8H
Potency Amount : 0
Potency Unit : NA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
EXCIPIENTS BY APPLICATIONS
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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