01 1CAMBREX CHARLES CITY, INC. Charles City US
02 1CORDEN PHARMA BERGAMO S.P.A. Treviglio IT
03 1JIANGSU RUIKE PHARMACEUTICAL SCI-TECH CO., LTD. Yancheng City CN
04 1VALENS MOLECULES PRIVATE LIMITED Hyderabad IN
05 1ZHEJIANG HISOAR PHARMACEUTICAL CO., LTD. Taizhou CN
06 1Zhejiang Jiuzhou Pharmaceutical Co., Ltd. Taizhou City CN
01 6Sulfasalazine
01 3China
02 1India
03 1Italy
04 1U.S.A
01 1Expired
02 3Valid
03 2Withdrawn by Holder
Certificate Number : R1-CEP 1996-040 - Rev 02
Status : Valid
Issue Date : 2007-08-30
Type : Chemical
Substance Number : 863
Certificate Number : R1-CEP 2004-278 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2017-12-20
Type : Chemical
Substance Number : 863
Certificate Number : R1-CEP 2016-225 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2022-01-10
Type : Chemical
Substance Number : 863
Certificate Number : R1-CEP 2016-085 - Rev 00
Status : Valid
Issue Date : 2023-01-19
Type : Chemical
Substance Number : 863
Certificate Number : R0-CEP 2015-073 - Rev 02
Status : Expired
Issue Date : 2020-01-06
Type : Chemical
Substance Number : 863
Certificate Number : R1-CEP 2002-088 - Rev 02
Status : Valid
Issue Date : 2015-03-20
Type : Chemical
Substance Number : 863
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.
A Sulfasalazine CEP of the European Pharmacopoeia monograph is often referred to as a Sulfasalazine Certificate of Suitability (COS). The purpose of a Sulfasalazine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sulfasalazine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sulfasalazine to their clients by showing that a Sulfasalazine CEP has been issued for it. The manufacturer submits a Sulfasalazine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sulfasalazine CEP holder for the record. Additionally, the data presented in the Sulfasalazine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sulfasalazine DMF.
A Sulfasalazine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sulfasalazine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Sulfasalazine suppliers with CEP (COS) on PharmaCompass.
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