Zach System is committed to providing Highly Customized Solutions for all your Development Programs.
01 1ZACH System SA
02 2Axplora
03 1LGM Pharma
04 1Gonane Pharma
05 1Aarti Pharmalabs
06 1ALP Pharm
07 1Aspire Lifesciences Pvt Ltd
08 2CHEMO
09 1Curia
10 1Fine Organics
11 1Guangzhou Topwork Chemical
12 1Industriale Chimica
13 1Maharshi Pharma Chem
14 1NEWCHEM SPA
15 1Nishchem International Pvt. Ltd
16 1Parth Antibiotics
17 1Reliance Life Sciences Private Limited
18 1SM BIOMED
19 1Sun Pharmaceutical Industries Limited
20 1Trifarma
21 1Unipex
01 2China
02 2France
03 2Germany
04 8India
05 3Italy
06 1Malaysia
07 2Spain
08 2U.S.A
09 1United Kingdom
01 7Active
02 3Inactive
03 13Blank
01 23Blank
01 23Blank
01 1WC-0099
02 1WC-0168
03 21Blank
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 : 2024-12-31
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 : 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 : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 25435
Submission : 2011-12-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11264
Submission : 1994-12-16
Status : Inactive
Type : II
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