Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36348
Submission : 2021-11-03
Status : Active
Type : IV
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19538
Submission : 2006-06-20
Status : Active
Type : IV
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37676
Submission : 2022-11-11
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16697
Submission : 2003-07-09
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18881
Submission : 2005-10-15
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14975
Submission : 2000-07-31
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11797
Submission : 1995-10-27
Status : Inactive
Type : IV
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36348
Submission : 2021-11-03
Status : Active
Type : IV
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37676
Submission : 2022-11-11
Status : Active
Type : IV
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19538
Submission : 2006-06-20
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18881
Submission : 2005-10-15
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16697
Submission : 2003-07-09
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11797
Submission : 1995-10-27
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14975
Submission : 2000-07-31
Status : Inactive
Type : IV
NDC Package Code : 51552-1527
Start Marketing Date : 2016-09-15
End Marketing Date : 2027-07-07
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 51552-1414
Start Marketing Date : 2012-04-01
End Marketing Date : 2027-04-15
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 51552-1530
Start Marketing Date : 2016-12-28
End Marketing Date : 2025-11-08
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
Application : Coating Systems & Additives
Excipient Details : Ready mix sugar coating system.
Pharmacopoeia Ref : USP, EP, JP & having US DMF
Technical Specs : Sprayable sugar coating system for solid oral dosage form
Ingredient(s) : Sucrose
Brand Name : SEPIFILM LP Range
Application : Coating Systems & Additives
Excipient Details : Coating, Moisture Protection
Pharmacopoeia Ref : Ph.Eur, USP-NF, JPE
Technical Specs : EXCiPACT
Ingredient(s) : HPMC Based Granules
Brand Name : SEPIFILM Classic Range
Application : Coating Systems & Additives
Excipient Details : Coating
Brand Name : SEPIFILM PW Range
Application : Coating Systems & Additives
Excipient Details : Coating
Brand Name : SEPISPERSE Dry Range
Application : Coating Systems & Additives
Excipient Details : Coloring Agents
Application : Coating Systems & Additives
Excipient Details : Coating
Application : Coating Systems & Additives
Excipient Details : Coating
Pharmacopoeia Ref : Not Available
Technical Specs : EXCiPACT
Ingredient(s) : HPMC & Sugar Based Granules
MARKET PLACE
REF. STANDARDS & IMPURITIES
LOOKING FOR A SUPPLIER?