01 1Cambrex Charles City, Inc.
02 1Valens Molecules Private Limited
03 1Zhejiang Jiuzhou Pharmaceutical Co. , Ltd.
01 1Salazosulfapyridine
02 2Sulfasalazine
01 1China
02 1India
03 1U.S.A
Registration Number : 219MF10098
Registrant's Address : 1205 11th Street, Charles City, Iowa, U.S. S. A.
Initial Date of Registration : 2007-03-14
Latest Date of Registration : 2019-03-19
Registration Number : 301MF10008
Registrant's Address : 202, SV'S Classic Residency, 6-3-853/2, Ameerpet, Hyderabad, Telangana-500 016, INDIA
Initial Date of Registration : 2019-05-28
Latest Date of Registration : 2019-05-28
Registration Number : 306MF10016
Registrant's Address : Waisha Road 99# Jiaojiang Taizhou City, Zhejiang China
Initial Date of Registration : 2024-01-24
Latest Date of Registration : 2024-01-24
A Sulfasalazine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sulfasalazine, including repackagers and relabelers. The FDA regulates Sulfasalazine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sulfasalazine 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 Sulfasalazine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sulfasalazine supplier is an individual or a company that provides Sulfasalazine active pharmaceutical ingredient (API) or Sulfasalazine finished formulations upon request. The Sulfasalazine suppliers may include Sulfasalazine API manufacturers, exporters, distributors and traders.
click here to find a list of Sulfasalazine 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 Sulfasalazine Drug Master File in Japan (Sulfasalazine JDMF) empowers Sulfasalazine 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 Sulfasalazine JDMF during the approval evaluation for pharmaceutical products. At the time of Sulfasalazine 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 Sulfasalazine suppliers with JDMF on PharmaCompass.
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