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Axplora- The partner of choice for complex APIs.
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01 1Axplora
02 1Medichem S.A
03 1CHEMO
04 1Guangzhou Tosun Pharmaceutical
05 1Harman Finochem
06 1Jubilant Generics
07 1PharmaBlock Sciences
08 1Procos
09 1Quimica Sintetica
10 2Sandoz B2B
11 1Torrent Pharmaceuticals Limited
12 1Unichem Laboratories Limited
13 1Zhejiang Guobang Pharmaceutical
01 3China
02 1Germany
03 4India
04 1Italy
05 3Spain
06 2Switzerland
01 8Active
02 2Inactive
03 4Blank
01 14Blank
01 1227MF10293
02 13Blank
01 1WC-0019
02 13Blank
Axplora- The partner of choice for complex APIs.
Date of Issue : 2022-03-18
Valid Till : 2025-05-28
Written Confirmation Number : WC-0019
Address of the Firm :
NDC Package Code : 12598-9508
Start Marketing Date : 2014-03-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-26
Pay. Date : 2013-02-05
DMF Number : 8590
Submission : 1990-06-12
Status : Active
Type : II
NDC Package Code : 53296-0024
Start Marketing Date : 2010-03-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-24
Pay. Date : 2014-06-19
DMF Number : 28312
Submission : 2014-05-19
Status : Active
Type : II
NDC Package Code : 46016-2911
Start Marketing Date : 2022-03-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36431
Submission : 2021-12-23
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-10-14
Pay. Date : 2020-09-08
DMF Number : 34653
Submission : 2020-03-26
Status : Active
Type : II
NDC Package Code : 53747-096
Start Marketing Date : 2020-03-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-08-01
Pay. Date : 2014-07-29
DMF Number : 8661
Submission : 1990-07-12
Status : Active
Type : II
Registration Number : 227MF10293
Registrant's Address : Calle Dulcinea, s/n 28805 Alcala De Henares Madrid Spain
Initial Date of Registration : 2015-12-24
Latest Date of Registration : --
NDC Package Code : 53069-0080
Start Marketing Date : 1995-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-27
Pay. Date : 2014-07-15
DMF Number : 28443
Submission : 2014-08-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39404
Submission : 2024-01-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4784
Submission : 1982-12-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4985
Submission : 1983-04-22
Status : Inactive
Type : II
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