Axplora is your partner of choice for complex APIs.

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01 1Axplora
02 1Zhejiang Hengkang Pharmaceutical
03 1IOL Chemicals and Pharmaceuticals
04 1Maithri Drugs
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 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 SA
23 1Institute Molecular biology
24 3Ipca Laboratories
25 2Lupin Ltd
26 1MSN Laboratories
27 1Optimus Pharma
28 1Pliva Hrvatska
29 1SIGMA TAU
30 1SIMS Srl
31 1Signa S.A. de C.V.
32 1Solara Active Pharma Sciences
33 3Sun Pharmaceutical Industries Limited
34 1Syntese AS
35 1The Dow Chemical Company
36 1Viatris
37 1Waitaki Biosciences
38 1Wanbury Limited
39 2Zydus Lifesciences
40 2Blank
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01 15-AMINO-2-HYDROXY BENZOIC ACID (MESALAMINE)
02 35-AMINOSALICYLIC ACID
03 15-AMINOSALICYLIC ACID (MESALAZINE/MESALAMINE)
04 15-AMINOSALICYLIC ACID DOSAGE FORM FOR CLINICAL RESEARCH
05 15-AMINOSALICYLIC ACID I (MESALAMINE)
06 15-ASA CRUDE (5-AMINOSALICYLIC ACID CRUDE)
07 1ASACOL (5-AMINOSALICYLIC ACID) TABLETS
08 1ASACOL TABLETS
09 6MESALAMINE
10 1MESALAMINE (5-AMINOSALICYLIC ACID) DRUG SUBSTANCE
11 1MESALAMINE CRYSTALLIZED, USP
12 1MESALAMINE HIGH DENSITY
13 20MESALAMINE USP
14 1MESALAMINE USP (5-AMINO SALICYLIC ACID)
15 1MESALAMINE USP (MZ3 PROCESS)
16 1MESALAMINE USP (PROCESS II)
17 1MESALAMINE USP (PROCESS-II)
18 1MESALAMINE USP - PH.EUR. (HIGH DENSITY)
19 1MESALAMINE USP-EP
20 1MESALAMINE/5-AMINOSALICYLIC ACID
21 2MESALAZINE
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
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01 1Belgium
02 2China
03 1Croatia
04 1Denmark
05 2Germany
06 23India
07 8Italy
08 1Japan
09 1Mexico
10 1New Zealand
11 1Spain
12 1Switzerland
13 7U.S.A
14 2Blank
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01 28Active
02 24Inactive
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01 16Complete
02 36Blank
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 : 31570
Submission : 2017-03-31
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 : 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 : 2015-09-28
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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PharmaCompass offers a list of Mesalazine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Mesalazine manufacturer or Mesalazine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mesalazine manufacturer or Mesalazine supplier.
A Pentacol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pentacol, including repackagers and relabelers. The FDA regulates Pentacol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pentacol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Pentacol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Pentacol supplier is an individual or a company that provides Pentacol active pharmaceutical ingredient (API) or Pentacol finished formulations upon request. The Pentacol suppliers may include Pentacol API manufacturers, exporters, distributors and traders.
click here to find a list of Pentacol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Pentacol DMF (Drug Master File) is a document detailing the whole manufacturing process of Pentacol active pharmaceutical ingredient (API) in detail. Different forms of Pentacol DMFs exist exist since differing nations have different regulations, such as Pentacol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pentacol DMF submitted to regulatory agencies in the US is known as a USDMF. Pentacol USDMF includes data on Pentacol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pentacol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pentacol suppliers with USDMF on PharmaCompass.
We have 38 companies offering Pentacol
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