Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1Zhejiang Hengkang Pharmaceutical
03 1IOL Chemicals and Pharmaceuticals
04 1ALP Pharm
05 1Ajinomoto OmniChem N.V.
06 1Alkem Laboratories
07 1Alvogen
08 1Amoli Organics
09 1Aurobindo Pharma Limited
10 1BEC Chemicals Pvt. Ltd
11 1Bayer AG
12 1CTX Lifesciences
13 2Cambrex Corporation
14 3Chemi SpA
15 1Cilag AG
16 2Corden Pharma Bergamo S.p.A
17 1Daiwa Chemical Industries
18 1Dasami Lab
19 1Divis Laboratories
20 1Eastman Chemical Company
21 2Erregierre SpA
22 1INFAR S.A.
23 1Institute Molecular biology
24 3Ipca Laboratories
25 2Lupin Ltd
26 1MSN Laboratories
27 1Maithri Drugs
28 1Optimus Pharma
29 1Pliva Hrvatska
30 1RANBAXY LABORATORIES LIMITED
31 1SIGMA TAU
32 1SIMS Srl
33 1Signa S.A. de C.V.
34 1Solara Active Pharma Sciences
35 2Sun Pharmaceutical Industries Limited
36 1Syntese AS
37 1Teva API
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 : 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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 7655
Submission : 1988-09-01
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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19618
Submission : 2006-07-21
Status : Active
Type : II
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