01 2Chemtura Corporation Middlebury US
02 1Mallinckrodt Inc St Louis US
03 1SO.G.I.S Industria Chimica SpA Sospiro IT
01 2Calcium stearate
02 1Calcium stearate, (Code numbers 2246, 2247, 2241)
03 1Sodium stearate
01 1Italy
02 3U.S.A
01 4Valid
Certificate Number : R1-CEP 2001-006 - Rev 00
Status : Valid
Issue Date : 2006-05-31
Type : TSE
Substance Number : 882
Certificate Number : R1-CEP 2001-010 - Rev 00
Status : Valid
Issue Date : 2007-01-25
Type : TSE
Substance Number : 2058
Calcium Stearate, (Code Numbers 2246, 2247, 2241...
Certificate Number : R1-CEP 2000-177 - Rev 01
Status : Valid
Issue Date : 2006-11-15
Type : TSE
Substance Number : 882
Certificate Number : R1-CEP 2001-040 - Rev 01
Status : Valid
Issue Date : 2022-03-03
Type : Chemical and TSE
Substance Number : 882
A Calcium Stearate API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcium Stearate API, including repackagers and relabelers. The FDA regulates Calcium Stearate API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcium Stearate API 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 Calcium Stearate API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Calcium Stearate API supplier is an individual or a company that provides Calcium Stearate API active pharmaceutical ingredient (API) or Calcium Stearate API finished formulations upon request. The Calcium Stearate API suppliers may include Calcium Stearate API API manufacturers, exporters, distributors and traders.
click here to find a list of Calcium Stearate API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Calcium Stearate API CEP of the European Pharmacopoeia monograph is often referred to as a Calcium Stearate API Certificate of Suitability (COS). The purpose of a Calcium Stearate API CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Calcium Stearate API EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Calcium Stearate API to their clients by showing that a Calcium Stearate API CEP has been issued for it. The manufacturer submits a Calcium Stearate API CEP (COS) as part of the market authorization procedure, and it takes on the role of a Calcium Stearate API CEP holder for the record. Additionally, the data presented in the Calcium Stearate API CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Calcium Stearate API DMF.
A Calcium Stearate API CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Calcium Stearate API 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 Calcium Stearate API suppliers with CEP (COS) on PharmaCompass.
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