01 1Chemtura Corporation Middlebury US
01 1Zinc stearate
01 1U.S.A
01 1Valid
Certificate Number : R1-CEP 2001-008 - Rev 00
Status : Valid
Issue Date : 2007-01-25
Type : TSE
Substance Number : 306
A Zinc Stearate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zinc Stearate, including repackagers and relabelers. The FDA regulates Zinc Stearate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zinc Stearate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Zinc Stearate supplier is an individual or a company that provides Zinc Stearate active pharmaceutical ingredient (API) or Zinc Stearate finished formulations upon request. The Zinc Stearate suppliers may include Zinc Stearate API manufacturers, exporters, distributors and traders.
click here to find a list of Zinc Stearate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zinc Stearate CEP of the European Pharmacopoeia monograph is often referred to as a Zinc Stearate Certificate of Suitability (COS). The purpose of a Zinc Stearate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Zinc Stearate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Zinc Stearate to their clients by showing that a Zinc Stearate CEP has been issued for it. The manufacturer submits a Zinc Stearate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Zinc Stearate CEP holder for the record. Additionally, the data presented in the Zinc Stearate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Zinc Stearate DMF.
A Zinc Stearate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Zinc Stearate 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 Zinc Stearate suppliers with CEP (COS) on PharmaCompass.
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