01 1ANUH PHARMA LTD. Mumbai IN
02 1F Hoffmann-La Roche Ltd. Basel CH
03 1MANGALAM DRUGS & ORGANICS LTD. Mumbai IN
01 3Sulfadoxine
01 2India
02 1U.S.A
01 3Valid
Certificate Number : CEP 2022-457 - Rev 00
Status : Valid
Issue Date : 2024-02-23
Type : Chemical
Substance Number : 740
Certificate Number : R1-CEP 2000-066 - Rev 04
Status : Valid
Issue Date : 2015-09-24
Type : Chemical
Substance Number : 740
Certificate Number : R0-CEP 2021-186 - Rev 00
Status : Valid
Issue Date : 2022-10-27
Type : Chemical
Substance Number : 740
A Sulfadoxine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sulfadoxine, including repackagers and relabelers. The FDA regulates Sulfadoxine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sulfadoxine 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 Sulfadoxine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sulfadoxine supplier is an individual or a company that provides Sulfadoxine active pharmaceutical ingredient (API) or Sulfadoxine finished formulations upon request. The Sulfadoxine suppliers may include Sulfadoxine API manufacturers, exporters, distributors and traders.
click here to find a list of Sulfadoxine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sulfadoxine CEP of the European Pharmacopoeia monograph is often referred to as a Sulfadoxine Certificate of Suitability (COS). The purpose of a Sulfadoxine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sulfadoxine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sulfadoxine to their clients by showing that a Sulfadoxine CEP has been issued for it. The manufacturer submits a Sulfadoxine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sulfadoxine CEP holder for the record. Additionally, the data presented in the Sulfadoxine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sulfadoxine DMF.
A Sulfadoxine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sulfadoxine 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 Sulfadoxine suppliers with CEP (COS) on PharmaCompass.
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