Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1Zhejiang Hengkang Pharmaceutical
03 1IOL Chemicals and Pharmaceuticals
04 1TAPI Technology & API Services
05 1ALP Pharm
06 1Ajinomoto OmniChem N.V.
07 1Alkem Laboratories
08 1Alvogen
09 1Amoli Organics
10 1Aurobindo Pharma Limited
11 1BEC Chemicals Pvt. Ltd
12 1Bayer AG
13 1CTX Lifesciences
14 2Cambrex Corporation
15 3Chemi SpA
16 1Cilag AG
17 2Corden Pharma Bergamo S.p.A
18 1Daiwa Chemical Industries
19 1Dasami Lab
20 1Divis Laboratories
21 1Eastman Chemical Company
22 2Erregierre SpA
23 1INFAR SA
24 1Institute Molecular biology
25 3Ipca Laboratories
26 2Lupin Ltd
27 1MSN Laboratories
28 1Maithri Drugs
29 1Optimus Pharma
30 1Pliva Hrvatska
31 1RANBAXY LABORATORIES LIMITED
32 1SIGMA TAU
33 1SIMS Srl
34 1Signa S.A. de C.V.
35 1Solara Active Pharma Sciences
36 2Sun Pharmaceutical Industries Limited
37 1Syntese AS
38 1The Dow Chemical Company
39 1Viatris
40 1Waitaki Biosciences
41 1Wanbury Limited
42 2Zydus Lifesciences
43 1Blank
01 45-AMINOSALICYLIC ACID
02 15-AMINOSALICYLIC ACID (MESALAZINE/MESALAMINE)
03 15-AMINOSALICYLIC ACID DOSAGE FORM FOR CLINICAL RESEARCH
04 15-AMINOSALICYLIC ACID I (MESALAMINE)
05 15-ASA CRUDE (5-AMINOSALICYLIC ACID CRUDE)
06 1ASACOL (5-AMINOSALICYLIC ACID) TABLETS
07 1ASACOL TABLETS
08 6MESALAMINE
09 1MESALAMINE (5-AMINOSALICYLIC ACID) DRUG SUBSTANCE
10 1MESALAMINE CRYSTALLIZED, USP
11 1MESALAMINE HIGH DENSITY
12 20MESALAMINE USP
13 1MESALAMINE USP (5-AMINO SALICYLIC ACID)
14 1MESALAMINE USP (MZ3 PROCESS)
15 1MESALAMINE USP (PROCESS II)
16 1MESALAMINE USP (PROCESS-II)
17 1MESALAMINE USP - PH.EUR. (HIGH DENSITY)
18 1MESALAMINE USP-EP
19 1MESALAMINE/5-AMINOSALICYLIC ACID
20 2MESALAZINE
21 1MESALAZINE N
22 1SALOFALK 250MG MESALAMINE ENTERIC COATED TABLETS
23 1TERMINAL STERILIZATION PROGRAM IN GRAND ISLAND, NEW YORK.
24 1TERMINAL STERILZATION PROGRAM IN MELROSE PARK, ILLINOIS.
25 1TOXICITY REPORTS FOR KOLLICOATS RS 30 D PROCESSS FACILITY
01 1Belgium
02 2China
03 1Croatia
04 1Denmark
05 3Germany
06 23India
07 1Israel
08 8Italy
09 1Japan
10 1Mexico
11 1New Zealand
12 1Spain
13 1Switzerland
14 7U.S.A
15 1Blank
01 29Active
02 24Inactive
01 18Complete
02 35Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-16
Pay. Date : 2014-11-28
DMF Number : 8070
Submission : 1989-05-09
Status : Active
Type : II
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
GDUFA
DMF Review : Complete
Rev. Date : 2022-10-20
Pay. Date : 2022-09-16
DMF Number : 37319
Submission : 2022-08-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38338
Submission : 2023-10-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11280
Submission : 1995-01-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7655
Submission : 1988-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-28
Pay. Date : 2013-03-18
DMF Number : 5693
Submission : 1985-01-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-27
Pay. Date : 2012-11-19
DMF Number : 11951
Submission : 1996-04-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-04-21
Pay. Date : 2014-10-22
DMF Number : 11807
Submission : 1996-01-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-28
Pay. Date : 2015-09-18
DMF Number : 13883
Submission : 1998-12-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18742
Submission : 2005-09-09
Status : Active
Type : II
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