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
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-16
Pay. Date : 2014-11-28
DMF Number : 8070
Submission : 1989-05-09
Status :
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 :
Type : II
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38338
Submission : 2023-10-14
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11280
Submission : 1995-01-04
Status :
Type : II
A Mesalazine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mesalazine, including repackagers and relabelers. The FDA regulates Mesalazine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mesalazine 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 Mesalazine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mesalazine supplier is an individual or a company that provides Mesalazine active pharmaceutical ingredient (API) or Mesalazine finished formulations upon request. The Mesalazine suppliers may include Mesalazine API manufacturers, exporters, distributors and traders.
click here to find a list of Mesalazine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mesalazine DMF (Drug Master File) is a document detailing the whole manufacturing process of Mesalazine active pharmaceutical ingredient (API) in detail. Different forms of Mesalazine DMFs exist exist since differing nations have different regulations, such as Mesalazine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mesalazine DMF submitted to regulatory agencies in the US is known as a USDMF. Mesalazine USDMF includes data on Mesalazine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mesalazine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mesalazine suppliers with USDMF on PharmaCompass.
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