Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1LGM Pharma
03 1Aarti Pharmalabs
04 1Hubei Gedian Humanwell Pharmaceutical
05 1ACS DOBFAR SPA
06 2Bristol Myers Squibb
07 1DEAFARMA
08 1Guangzhou Topwork Chemical
09 1Guangzhou Tosun Pharmaceutical
10 1NEWCHEM SPA
11 1SM BIOMED
12 1Symbiotica Specialty Ingredients
13 1Teva API
14 1Teva Pharmaceutical Industries
15 1Unipex
16 1Blank
01 3China
02 1France
03 1Germany
04 1India
05 2Israel
06 3Italy
07 2Malaysia
08 3U.S.A
09 1Blank
01 3Active
02 5Inactive
03 9Blank
01 17Blank
01 17Blank
01 1WC-0099
02 16Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-09-05
Pay. Date : 2014-09-03
DMF Number : 19574
Submission : 2006-07-06
Status : Active
Type : II
NDC Package Code : 46439-8713
Start Marketing Date : 1992-03-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Available Reg Filing : EU, CN |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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 : 22963
Submission : 2009-07-20
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 : 15308-0713
Start Marketing Date : 1983-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
NDC Package Code : 51508-009
Start Marketing Date : 2021-05-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-17
Pay. Date : 2014-01-14
DMF Number : 4420
Submission : 1982-02-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22749
Submission : 2009-04-21
Status : Inactive
Type : II
NDC Package Code : 24002-0014
Start Marketing Date : 2009-08-11
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3100
Submission : 1978-01-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1244
Submission : 1968-10-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4008
Submission : 1980-12-05
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5476
Submission : 1984-07-05
Status : Inactive
Type : II
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