Aspen API. More than just an API.
01 1Aspen API
02 1Medichem S.A
03 2Megafine Pharma (P) Limited
04 3Neuland Laboratories
05 1Angelini Pharma
06 1Aurobindo Pharma Limited
07 1Fujifilm Diosynth Biotechnologies
08 1Hetero Drugs
09 2Maithri Drugs
10 1Micro Labs Limited
11 1Sumitomo Chemical
12 1Sun Pharmaceutical Industries Limited
13 1Syn-Tech Chem. & Pharm
14 1Teva API
15 2Viatris
16 1Zhejiang Liaoyuan Pharmaceutical Co LTD
01 11-(3-HYDROXYMETHYLPYRIDYL-2)-2-PHENYL-4-METHYLPIPERAZINE (M3 INTERMEDIATE FOR MIRTAZAPINE)
02 8MIRTAZAPINE
03 2MIRTAZAPINE ANHYDROUS USP
04 1MIRTAZAPINE ANHYDROUS USP (NON-STERILE DRUG SUBSTANCE)
05 1MIRTAZAPINE HEMIHYDRATE USP (NON STERILE DRUG SUBSTANCE)
06 2MIRTAZAPINE USP
07 1MIRTAZAPINE USP (ACETONE ROUTE)
08 1MIRTAZAPINE USP (ANHYDROUS)
09 1MIRTAZAPINE USP (HEMIHYDRATE)
10 1MIRTAZAPINE USP [HEMIHYDRATE]
11 1MIRTAZAPINE USP [ROUTE CODE - MZ)
12 1MIRTAZAPINE, USP (ANHYDROUS)
01 1China
02 11India
03 1Israel
04 1Italy
05 1Japan
06 1Netherlands
07 1Spain
08 1Taiwan
09 2U.S.A
10 1United Kingdom
01 16Active
02 5Inactive
01 5Complete
02 16Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10457
Submission : 1993-08-30
Status : Active
Type : II
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-30
Pay. Date : 2013-04-17
DMF Number : 15749
Submission : 2001-12-05
Status : Active
Type : II
Megafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20570
Submission : 2007-05-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16007
Submission : 2002-06-11
Status : Active
Type : II
Megafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-07
Pay. Date : 2013-09-26
DMF Number : 23003
Submission : 2009-07-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-28
Pay. Date : 2023-11-24
DMF Number : 30850
Submission : 2016-09-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24022
Submission : 2010-08-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16490
Submission : 2003-03-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16113
Submission : 2002-08-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15323
Submission : 2001-03-02
Status : Active
Type : II
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