Axplora- The partner of choice for complex APIs.
01 1PharmaZell (India) Private Limited
02 2PharmaZell GmbH
03 2Zhejiang Hengkang Pharmaceutical Co. , Ltd.
04 1Bayer Pharma AG
05 1CHEMI S. p. A.
06 1Cadila Healthcare Limited
07 1Cambrex Karlskoga AB
08 1DIVI'S LABORATORIES LIMITED
09 2ERREGIERRE S. p. A.
10 1SUN PHARMACEUTICAL INDUSTRIES LTD.
Axplora- The partner of choice for complex APIs.
Registration Number : 219MF10036
Registrant's Address : ROSENHEIMER STR. 43 D-83064 RAUBLING, Germany
Initial Date of Registration : 2007-02-13
Latest Date of Registration : 2016-02-02
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
Registration Number : 305MF10102
Registrant's Address : No. 11 Chengen Road, Pubagan Town, Sanmen, Zhejiang, China
Initial Date of Registration : 2023-08-30
Latest Date of Registration : 2023-08-30
Axplora- The partner of choice for complex APIs.
Registration Number : 226MF10019
Registrant's Address : ROSENHEIMER STR. 43 D-83064 RAUBLING, GERMARY
Initial Date of Registration : 2014-01-21
Latest Date of Registration : 2014-01-21
Axplora- The partner of choice for complex APIs.
Registration Number : 226MF10064
Registrant's Address : Plot No. 115, Visakha Pharmacity Limited, SEZ, Parawada, Anakapalli - 531 019, Andhra...
Initial Date of Registration : 2014-03-11
Latest Date of Registration : 2014-03-11
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
Registration Number : 227MF10271
Registrant's Address : No. 1 Longxiang Road, Hairun Street, Sanmen, Zhejiang, China
Initial Date of Registration : 2015-12-01
Latest Date of Registration : 2015-12-01
A Mesalamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mesalamine, including repackagers and relabelers. The FDA regulates Mesalamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mesalamine 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 Mesalamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mesalamine supplier is an individual or a company that provides Mesalamine active pharmaceutical ingredient (API) or Mesalamine finished formulations upon request. The Mesalamine suppliers may include Mesalamine API manufacturers, exporters, distributors and traders.
click here to find a list of Mesalamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Mesalamine Drug Master File in Japan (Mesalamine JDMF) empowers Mesalamine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Mesalamine JDMF during the approval evaluation for pharmaceutical products. At the time of Mesalamine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Mesalamine suppliers with JDMF on PharmaCompass.
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