Zach System is committed to providing Highly Customized Solutions for all your Development Programs.
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02 2Axplora
03 1LGM Pharma
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Zach System is committed to providing Highly Customized Solutions for all your Development Programs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-10-16
Pay. Date : 2024-10-08
DMF Number : 11105
Submission : 1994-09-26
Status : Active
Type : II
NDC Package Code : 60269-287
Start Marketing Date : 1998-03-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : BASH HEALTH KOREA CORP.
Registration Date : 2008-05-07
Registration Number : 4063-1-ND
Manufacturer Name : Zach system
Manufacturer Address : Zone Industrielle La Croix Cadeau Avrille, 49240, France
Available Reg Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26937
Submission : 2013-03-05
Status : Active
Type : II
NDC Package Code : 46439-8743
Start Marketing Date : 2012-04-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Available Reg Filing : EU |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26249
Submission : 2012-07-26
Status : Active
Type : II
Date of Issue : 2023-01-06
Valid Till : 2025-07-29
Written Confirmation Number : WC-0099
Address of the Firm :
NDC Package Code : 15308-0722
Start Marketing Date : 2011-06-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2024-03-14
Registration Number : Su289-18-ND
Manufacturer Name : Aarti Pharmalabs Limited
Manufacturer Address : Plot No. E–50, 50/1 & 59/1, Unit-IV, MIDC, Tarapur, Taluka & District-Palghar, 401 506, Maharashtra State, India.
Available Reg Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-07-05
Pay. Date : 2023-01-24
DMF Number : 27717
Submission : 2013-11-11
Status : Active
Type : II
NDC Package Code : 46439-8743
Start Marketing Date : 2012-04-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Available Reg Filing : EU |
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-03-20
Pay. Date : 2017-12-18
DMF Number : 32352
Submission : 2018-02-03
Status : Active
Type : II
Date of Issue : 2022-08-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0168
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-29
Pay. Date : 2014-03-20
DMF Number : 28031
Submission : 2014-03-07
Status : Active
Type : II
NDC Package Code : 65089-0037
Start Marketing Date : 1998-03-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-23
Pay. Date : 2015-04-03
DMF Number : 23672
Submission : 2010-04-01
Status : Active
Type : II
NDC Package Code : 63190-0220
Start Marketing Date : 1998-03-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11264
Submission : 1994-12-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22278
Submission : 2008-12-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25435
Submission : 2011-12-06
Status : Inactive
Type : II
74
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